European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide - Local Development build (v1.0.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

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Active as of 2025-04-02

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<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="200000029659"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: CodeSystem 200000029659</b></p><a name="200000029659"> </a><a name="hc200000029659"> </a><a name="200000029659-en-US"> </a><p>This case-insensitive code system <code>http://ema.europa.eu/fhir/CodeSystem/200000029659</code> defines the following codes:</p><table class="codes"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td></tr><tr><td style="white-space:nowrap">000000000000<a name="200000029659-000000000000"> </a></td><td>Code for custom sub-sections (reserved)</td></tr><tr><td style="white-space:nowrap">200000029791<a name="200000029659-200000029791"> </a></td><td>SUMMARY OF PRODUCT CHARACTERISTICS</td></tr><tr><td style="white-space:nowrap">200000029792<a name="200000029659-200000029792"> </a></td><td>1. NAME OF THE MEDICINAL PRODUCT</td></tr><tr><td style="white-space:nowrap">200000029793<a name="200000029659-200000029793"> </a></td><td>2. QUALITATIVE AND QUANTITATIVE COMPOSITION</td></tr><tr><td style="white-space:nowrap">200000029794<a name="200000029659-200000029794"> </a></td><td>2.1 General description</td></tr><tr><td style="white-space:nowrap">200000029795<a name="200000029659-200000029795"> </a></td><td>2.2 Qualitative and quantitative composition</td></tr><tr><td style="white-space:nowrap">200000029796<a name="200000029659-200000029796"> </a></td><td>Excipient(s) with known effect</td></tr><tr><td style="white-space:nowrap">200000029797<a name="200000029659-200000029797"> </a></td><td>3. PHARMACEUTICAL FORM</td></tr><tr><td style="white-space:nowrap">200000029798<a name="200000029659-200000029798"> </a></td><td>4. CLINICAL PARTICULARS</td></tr><tr><td style="white-space:nowrap">200000029799<a name="200000029659-200000029799"> </a></td><td>4.1 Therapeutic indications</td></tr><tr><td style="white-space:nowrap">200000029800<a name="200000029659-200000029800"> </a></td><td>4.2 Posology and method of administration</td></tr><tr><td style="white-space:nowrap">200000029801<a name="200000029659-200000029801"> </a></td><td>Posology</td></tr><tr><td style="white-space:nowrap">200000029802<a name="200000029659-200000029802"> </a></td><td>Paediatric population</td></tr><tr><td style="white-space:nowrap">200000029803<a name="200000029659-200000029803"> </a></td><td>Method of administration</td></tr><tr><td style="white-space:nowrap">200000029804<a name="200000029659-200000029804"> </a></td><td>Precautions to be taken before handling or administering the medicinal product</td></tr><tr><td style="white-space:nowrap">200000029805<a name="200000029659-200000029805"> </a></td><td>4.3 Contraindications</td></tr><tr><td style="white-space:nowrap">200000029806<a name="200000029659-200000029806"> </a></td><td>4.4 Special warnings and precautions for use</td></tr><tr><td style="white-space:nowrap">200000029807<a name="200000029659-200000029807"> </a></td><td>Traceability</td></tr><tr><td style="white-space:nowrap">200000029808<a name="200000029659-200000029808"> </a></td><td>Paediatric population</td></tr><tr><td style="white-space:nowrap">200000029809<a name="200000029659-200000029809"> </a></td><td>4.5 Interaction with other medicinal products and other forms of interaction</td></tr><tr><td style="white-space:nowrap">200000029810<a name="200000029659-200000029810"> </a></td><td>Paediatric population</td></tr><tr><td style="white-space:nowrap">200000029811<a name="200000029659-200000029811"> </a></td><td>4.6 Fertility, pregnancy and lactation</td></tr><tr><td style="white-space:nowrap">200000029812<a name="200000029659-200000029812"> </a></td><td>Pregnancy</td></tr><tr><td style="white-space:nowrap">200000029813<a name="200000029659-200000029813"> </a></td><td>Breast-feeding</td></tr><tr><td style="white-space:nowrap">200000029814<a name="200000029659-200000029814"> </a></td><td>Fertility</td></tr><tr><td style="white-space:nowrap">200000029815<a name="200000029659-200000029815"> </a></td><td>4.7 Effects on ability to drive and use machines</td></tr><tr><td style="white-space:nowrap">200000029816<a name="200000029659-200000029816"> </a></td><td>4.8 Undesirable effects</td></tr><tr><td style="white-space:nowrap">200000029817<a name="200000029659-200000029817"> </a></td><td>Paediatric population</td></tr><tr><td style="white-space:nowrap">200000029818<a name="200000029659-200000029818"> </a></td><td>Reporting of suspected adverse reactions</td></tr><tr><td style="white-space:nowrap">200000029819<a name="200000029659-200000029819"> </a></td><td>4.9 Overdose</td></tr><tr><td style="white-space:nowrap">200000029820<a name="200000029659-200000029820"> </a></td><td>Paediatric population</td></tr><tr><td style="white-space:nowrap">200000029821<a name="200000029659-200000029821"> </a></td><td>5. PHARMACOLOGICAL PROPERTIES</td></tr><tr><td style="white-space:nowrap">200000029822<a name="200000029659-200000029822"> </a></td><td>5.1 Pharmacodynamic properties</td></tr><tr><td style="white-space:nowrap">200000029823<a name="200000029659-200000029823"> </a></td><td>Mechanism of action</td></tr><tr><td style="white-space:nowrap">200000029824<a name="200000029659-200000029824"> </a></td><td>Pharmacodynamic effects</td></tr><tr><td style="white-space:nowrap">200000029825<a name="200000029659-200000029825"> </a></td><td>Clinical efficacy and safety</td></tr><tr><td style="white-space:nowrap">200000029826<a name="200000029659-200000029826"> </a></td><td>Paediatric population</td></tr><tr><td style="white-space:nowrap">200000029827<a name="200000029659-200000029827"> </a></td><td>5.2 Pharmacokinetic properties</td></tr><tr><td style="white-space:nowrap">200000029828<a name="200000029659-200000029828"> </a></td><td>Absorption</td></tr><tr><td style="white-space:nowrap">200000029829<a name="200000029659-200000029829"> </a></td><td>Distribution</td></tr><tr><td style="white-space:nowrap">200000029830<a name="200000029659-200000029830"> </a></td><td>Biotransformation</td></tr><tr><td style="white-space:nowrap">200000029831<a name="200000029659-200000029831"> </a></td><td>Elimination</td></tr><tr><td style="white-space:nowrap">200000029832<a name="200000029659-200000029832"> </a></td><td>Linearity/non-linearity</td></tr><tr><td style="white-space:nowrap">200000029833<a name="200000029659-200000029833"> </a></td><td>Pharmacokinetic/pharmacodynamic relationship(s)</td></tr><tr><td style="white-space:nowrap">200000029834<a name="200000029659-200000029834"> </a></td><td>5.3 Preclinical safety data</td></tr><tr><td style="white-space:nowrap">200000029835<a name="200000029659-200000029835"> </a></td><td>Environmental risk assessment (ERA)</td></tr><tr><td style="white-space:nowrap">200000029836<a name="200000029659-200000029836"> </a></td><td>6. PHARMACEUTICAL PARTICULARS</td></tr><tr><td style="white-space:nowrap">200000029837<a name="200000029659-200000029837"> </a></td><td>6.1 List of excipients</td></tr><tr><td style="white-space:nowrap">200000029838<a name="200000029659-200000029838"> </a></td><td>6.2 Incompatibilities</td></tr><tr><td style="white-space:nowrap">200000029839<a name="200000029659-200000029839"> </a></td><td>6.3 Shelf life</td></tr><tr><td style="white-space:nowrap">200000029840<a name="200000029659-200000029840"> </a></td><td>6.4 Special precautions for storage</td></tr><tr><td style="white-space:nowrap">200000029841<a name="200000029659-200000029841"> </a></td><td>6.5 Nature and contents of container [and special equipment for use, administration or implantation]</td></tr><tr><td style="white-space:nowrap">200000029842<a name="200000029659-200000029842"> </a></td><td>6.6 Special precautions for disposal [and other handling]</td></tr><tr><td style="white-space:nowrap">200000029843<a name="200000029659-200000029843"> </a></td><td>Use in the paediatric population</td></tr><tr><td style="white-space:nowrap">200000029844<a name="200000029659-200000029844"> </a></td><td>7. MARKETING AUTHORISATION HOLDER</td></tr><tr><td style="white-space:nowrap">200000029845<a name="200000029659-200000029845"> </a></td><td>8. MARKETING AUTHORISATION NUMBER(S)</td></tr><tr><td style="white-space:nowrap">200000029846<a name="200000029659-200000029846"> </a></td><td>9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION</td></tr><tr><td style="white-space:nowrap">200000029847<a name="200000029659-200000029847"> </a></td><td>10. DATE OF REVISION OF THE TEXT</td></tr><tr><td style="white-space:nowrap">200000029848<a name="200000029659-200000029848"> </a></td><td>11. DOSIMETRY</td></tr><tr><td style="white-space:nowrap">200000029849<a name="200000029659-200000029849"> </a></td><td>12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS</td></tr><tr><td style="white-space:nowrap">200000029850<a name="200000029659-200000029850"> </a></td><td>ANNEX II</td></tr><tr><td style="white-space:nowrap">200000029851<a name="200000029659-200000029851"> </a></td><td>A. [MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND] MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE</td></tr><tr><td style="white-space:nowrap">200000029852<a name="200000029659-200000029852"> </a></td><td>B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE</td></tr><tr><td style="white-space:nowrap">200000029853<a name="200000029659-200000029853"> </a></td><td>Official batch release</td></tr><tr><td style="white-space:nowrap">200000029854<a name="200000029659-200000029854"> </a></td><td>C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION</td></tr><tr><td style="white-space:nowrap">200000029855<a name="200000029659-200000029855"> </a></td><td>Periodic safety update reports (PSURs)</td></tr><tr><td style="white-space:nowrap">200000029856<a name="200000029659-200000029856"> </a></td><td>D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT</td></tr><tr><td style="white-space:nowrap">200000029857<a name="200000029659-200000029857"> </a></td><td>Risk management plan (RMP)</td></tr><tr><td style="white-space:nowrap">200000029858<a name="200000029659-200000029858"> </a></td><td>Additional risk minimisation measures</td></tr><tr><td style="white-space:nowrap">200000029859<a name="200000029659-200000029859"> </a></td><td>Obligation to conduct post-authorisation measures</td></tr><tr><td style="white-space:nowrap">200000029860<a name="200000029659-200000029860"> </a></td><td>E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR [THE CONDITIONAL MARKETING AUTHORISATION] [THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES</td></tr><tr><td style="white-space:nowrap">200000029861<a name="200000029659-200000029861"> </a></td><td>LABELLING</td></tr><tr><td style="white-space:nowrap">200000029862<a name="200000029659-200000029862"> </a></td><td>PARTICULARS TO APPEAR ON [THE OUTER PACKAGING] [AND] [THE IMMEDIATE PACKAGING] {NATURE/TYPE}</td></tr><tr><td style="white-space:nowrap">200000029863<a name="200000029659-200000029863"> </a></td><td>1. NAME OF THE MEDICINAL PRODUCT</td></tr><tr><td style="white-space:nowrap">200000029864<a name="200000029659-200000029864"> </a></td><td>2. STATEMENT OF ACTIVE SUBSTANCE(S)</td></tr><tr><td style="white-space:nowrap">200000029865<a name="200000029659-200000029865"> </a></td><td>3. LIST OF EXCIPIENTS</td></tr><tr><td style="white-space:nowrap">200000029866<a name="200000029659-200000029866"> </a></td><td>4. PHARMACEUTICAL FORM AND CONTENTS</td></tr><tr><td style="white-space:nowrap">200000029867<a name="200000029659-200000029867"> </a></td><td>5. METHOD AND ROUTE(S) OF ADMINISTRATION</td></tr><tr><td style="white-space:nowrap">200000029868<a name="200000029659-200000029868"> </a></td><td>6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN</td></tr><tr><td style="white-space:nowrap">200000029869<a name="200000029659-200000029869"> </a></td><td>7. OTHER SPECIAL WARNING(S), IF NECESSARY</td></tr><tr><td style="white-space:nowrap">200000029870<a name="200000029659-200000029870"> </a></td><td>8. EXPIRY DATE</td></tr><tr><td style="white-space:nowrap">200000029871<a name="200000029659-200000029871"> </a></td><td>9. SPECIAL STORAGE CONDITIONS</td></tr><tr><td style="white-space:nowrap">200000029872<a name="200000029659-200000029872"> </a></td><td>10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE</td></tr><tr><td style="white-space:nowrap">200000029873<a name="200000029659-200000029873"> </a></td><td>11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER</td></tr><tr><td style="white-space:nowrap">200000029874<a name="200000029659-200000029874"> </a></td><td>12. MARKETING AUTHORISATION NUMBER(S)</td></tr><tr><td style="white-space:nowrap">200000029875<a name="200000029659-200000029875"> </a></td><td>13. BATCH NUMBER[, DONATION AND PRODUCT CODES]</td></tr><tr><td style="white-space:nowrap">200000029876<a name="200000029659-200000029876"> </a></td><td>14. GENERAL CLASSIFICATION FOR SUPPLY</td></tr><tr><td style="white-space:nowrap">200000029877<a name="200000029659-200000029877"> </a></td><td>15. INSTRUCTIONS ON USE</td></tr><tr><td style="white-space:nowrap">200000029878<a name="200000029659-200000029878"> </a></td><td>16. INFORMATION IN BRAILLE</td></tr><tr><td style="white-space:nowrap">200000029879<a name="200000029659-200000029879"> </a></td><td>17. UNIQUE IDENTIFIER - 2D BARCODE</td></tr><tr><td style="white-space:nowrap">200000029880<a name="200000029659-200000029880"> </a></td><td>18. UNIQUE IDENTIFIER - HUMAN READABLE DATA</td></tr><tr><td style="white-space:nowrap">200000029881<a name="200000029659-200000029881"> </a></td><td>MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {NATURE/TYPE}</td></tr><tr><td style="white-space:nowrap">200000029882<a name="200000029659-200000029882"> </a></td><td>1. NAME OF THE MEDICINAL PRODUCT</td></tr><tr><td style="white-space:nowrap">200000029883<a name="200000029659-200000029883"> </a></td><td>2. NAME OF THE MARKETING AUTHORISATION HOLDER</td></tr><tr><td style="white-space:nowrap">200000029884<a name="200000029659-200000029884"> </a></td><td>3. EXPIRY DATE</td></tr><tr><td style="white-space:nowrap">200000029885<a name="200000029659-200000029885"> </a></td><td>4. BATCH NUMBER[, DONATION AND PRODUCT CODES]</td></tr><tr><td style="white-space:nowrap">200000029886<a name="200000029659-200000029886"> </a></td><td>5. OTHER</td></tr><tr><td style="white-space:nowrap">200000029887<a name="200000029659-200000029887"> </a></td><td>MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {NATURE/TYPE}</td></tr><tr><td style="white-space:nowrap">200000029888<a name="200000029659-200000029888"> </a></td><td>1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION</td></tr><tr><td style="white-space:nowrap">200000029889<a name="200000029659-200000029889"> </a></td><td>2. METHOD OF ADMINISTRATION</td></tr><tr><td style="white-space:nowrap">200000029890<a name="200000029659-200000029890"> </a></td><td>3. EXPIRY DATE</td></tr><tr><td style="white-space:nowrap">200000029891<a name="200000029659-200000029891"> </a></td><td>4. BATCH NUMBER[, DONATION AND PRODUCT CODES]</td></tr><tr><td style="white-space:nowrap">200000029892<a name="200000029659-200000029892"> </a></td><td>5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT</td></tr><tr><td style="white-space:nowrap">200000029893<a name="200000029659-200000029893"> </a></td><td>6. OTHER</td></tr><tr><td style="white-space:nowrap">200000029894<a name="200000029659-200000029894"> </a></td><td>PACKAGE LEAFLET</td></tr><tr><td style="white-space:nowrap">200000029895<a name="200000029659-200000029895"> </a></td><td>1. What X is and what it is used for</td></tr><tr><td style="white-space:nowrap">200000029896<a name="200000029659-200000029896"> </a></td><td>2. What you need to know before you [take] [use] X</td></tr><tr><td style="white-space:nowrap">200000029897<a name="200000029659-200000029897"> </a></td><td>Do not [take] [use] X</td></tr><tr><td style="white-space:nowrap">200000029898<a name="200000029659-200000029898"> </a></td><td>Warnings and precautions</td></tr><tr><td style="white-space:nowrap">200000029899<a name="200000029659-200000029899"> </a></td><td>Children [and adolescents]</td></tr><tr><td style="white-space:nowrap">200000029900<a name="200000029659-200000029900"> </a></td><td>Other medicines and X</td></tr><tr><td style="white-space:nowrap">200000029901<a name="200000029659-200000029901"> </a></td><td>X with [food] [and] [,] [drink] [and] [alcohol]</td></tr><tr><td style="white-space:nowrap">200000029902<a name="200000029659-200000029902"> </a></td><td>Pregnancy [and] [,] breast-feeding [and fertility]</td></tr><tr><td style="white-space:nowrap">200000029903<a name="200000029659-200000029903"> </a></td><td>Driving and using machines</td></tr><tr><td style="white-space:nowrap">200000029904<a name="200000029659-200000029904"> </a></td><td>X contains {name the excipient(s)}</td></tr><tr><td style="white-space:nowrap">200000029905<a name="200000029659-200000029905"> </a></td><td>3. How to [take] [use] X</td></tr><tr><td style="white-space:nowrap">200000029906<a name="200000029659-200000029906"> </a></td><td>Use in children [and adolescents]</td></tr><tr><td style="white-space:nowrap">200000029907<a name="200000029659-200000029907"> </a></td><td>If you [take] [use] more X than you should</td></tr><tr><td style="white-space:nowrap">200000029908<a name="200000029659-200000029908"> </a></td><td>If you forget to [take] [use] X</td></tr><tr><td style="white-space:nowrap">200000029909<a name="200000029659-200000029909"> </a></td><td>If you stop [taking] [using] X</td></tr><tr><td style="white-space:nowrap">200000029910<a name="200000029659-200000029910"> </a></td><td>4. Possible side effects</td></tr><tr><td style="white-space:nowrap">200000029911<a name="200000029659-200000029911"> </a></td><td>Additional side effects in children [and adolescents]</td></tr><tr><td style="white-space:nowrap">200000029912<a name="200000029659-200000029912"> </a></td><td>Reporting of side effects</td></tr><tr><td style="white-space:nowrap">200000029913<a name="200000029659-200000029913"> </a></td><td>5. How to store X</td></tr><tr><td style="white-space:nowrap">200000029914<a name="200000029659-200000029914"> </a></td><td>6. Contents of the pack and other information</td></tr><tr><td style="white-space:nowrap">200000029915<a name="200000029659-200000029915"> </a></td><td>What X contains</td></tr><tr><td style="white-space:nowrap">200000029916<a name="200000029659-200000029916"> </a></td><td>What X looks like and contents of the pack</td></tr><tr><td style="white-space:nowrap">200000029917<a name="200000029659-200000029917"> </a></td><td>Marketing Authorisation Holder and Manufacturer</td></tr><tr><td style="white-space:nowrap">200000029918<a name="200000029659-200000029918"> </a></td><td>This medicine is authorised in the Member States of the European Economic Area [and in the United Kingdom (Northern Ireland)] under the following names:</td></tr><tr><td style="white-space:nowrap">200000029919<a name="200000029659-200000029919"> </a></td><td>This leaflet was last revised in [{MM/YYYY}][{month YYYY}].</td></tr><tr><td style="white-space:nowrap">200000029920<a name="200000029659-200000029920"> </a></td><td>Other sources of information</td></tr><tr><td style="white-space:nowrap">200000029921<a name="200000029659-200000029921"> </a></td><td>The following information is intended for healthcare professionals only:</td></tr><tr><td style="white-space:nowrap">200000044346<a name="200000029659-200000044346"> </a></td><td>Level=H3 PL custom subsection</td></tr><tr><td style="white-space:nowrap">200000044333<a name="200000029659-200000044333"> </a></td><td>Level=H4 SmPC custom subsection</td></tr><tr><td style="white-space:nowrap">200000044347<a name="200000029659-200000044347"> </a></td><td>Level=H5 SmPC custom subsection</td></tr></table><p><b>Additional Language Displays</b></p><table class="codes"><tr><td><b>Code</b></td><td><b>Bulgarian (bg)</b></td><td><b>Czech (cs)</b></td><td><b>Dansk (Danish, da)</b></td><td><b>Deutsch (German, de)</b></td><td><b>Greek (el)</b></td><td><b>English (English, en)</b></td><td><b>Spanish (es)</b></td><td><b>Estonian (et)</b></td><td><b>Finnish (fi)</b></td><td><b>French (fr)</b></td><td><b>ga</b></td><td><b>Croatian (hr)</b></td><td><b>hu</b></td><td><b>Icelandic (is)</b></td><td><b>Italian (it)</b></td><td><b>Lithuanian (lt)</b></td><td><b>Latvian (lv)</b></td><td><b>mt</b></td><td><b>Nederlands (Dutch, nl)</b></td><td><b>Norwegian (no)</b></td><td><b>Polskie (Polish, pl)</b></td><td><b>Portuguese (pt)</b></td><td><b>Romanian (ro)</b></td><td><b>Slovakian (sk)</b></td><td><b>Slovenian (sl)</b></td><td><b>Swedish (sv)</b></td></tr><tr><td>000000000000</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>200000029791</td><td>КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА</td><td>SOUHRN ÚDAJŮ O PŘÍPRAVKU</td><td>PRODUKTRESUMÉ</td><td>ZUSAMMENFASSUNG DER MERKMALE DES ARZNEIMITTELS</td><td>ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ</td><td>SUMMARY OF PRODUCT CHARACTERISTICS</td><td>FICHA TÉCNICA O RESUMEN DE LAS CARACTERÍSTICAS DEL PRODUCTO</td><td>RAVIMI OMADUSTE KOKKUVÕTE</td><td>VALMISTEYHTEENVETO</td><td>RÉSUMÉ DES CARACTÉRISTIQUES DU PRODUIT</td><td>ACHOIMRE AR SHAINTRÉITHE AN TÁIRGE</td><td>SAŽETAK OPISA SVOJSTAVA LIJEKA</td><td>ALKALMAZÁSI ELŐÍRÁS</td><td>SAMANTEKT Á EIGINLEIKUM LYFS</td><td>RIASSUNTO DELLE CARATTERISTICHE DEL PRODOTTO</td><td>PREPARATO CHARAKTERISTIKŲ SANTRAUKA</td><td>ZĀĻU APRAKSTS</td><td>SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT</td><td>SAMENVATTING VAN DE PRODUCTKENMERKEN</td><td>PREPARATOMTALE</td><td>CHARAKTERYSTYKA PRODUKTU LECZNICZEGO</td><td>RESUMO DAS CARACTERÍSTICAS DO MEDICAMENTO</td><td>REZUMATUL CARACTERISTICILOR PRODUSULUI</td><td>SÚHRN CHARAKTERISTICKÝCH VLASTNOSTÍ LIEKU</td><td>POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA</td><td>PRODUKTRESUMÉ</td></tr><tr><td>200000029792</td><td>1. ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ</td><td>1. NÁZEV PŘÍPRAVKU</td><td>1. LÆGEMIDLETS NAVN</td><td>1. BEZEICHNUNG DES ARZNEIMITTELS</td><td>1. ΟΝΟΜΑΣΙΑ ΤΟΥ ΦΑΡΜΑΚΕΥΤΙΚΟΥ ΠΡΟΪΟΝΤΟΣ</td><td>1. NAME OF THE MEDICINAL PRODUCT</td><td>1. NOMBRE DEL MEDICAMENTO</td><td>1. RAVIMPREPARAADI NIMETUS</td><td>1. LÄÄKEVALMISTEEN NIMI</td><td>1. DÉNOMINATION DU MÉDICAMENT</td><td>1. AINM AN TÁIRGE ÍOCSHLÁINTE</td><td>1. NAZIV LIJEKA</td><td>1. A GYÓGYSZER NEVE</td><td>1. HEITI LYFS</td><td>1. DENOMINAZIONE DEL MEDICINALE</td><td>1. VAISTINIO PREPARATO PAVADINIMAS</td><td>1. ZĀĻU NOSAUKUMS</td><td>1. ISEM IL-PRODOTT MEDIĊINALI</td><td>1. NAAM VAN HET GENEESMIDDEL</td><td>1. LEGEMIDLETS NAVN</td><td>1. NAZWA PRODUKTU LECZNICZEGO</td><td>1. NOME DO MEDICAMENTO</td><td>1. DENUMIREA COMERCIALĂ A MEDICAMENTULUI</td><td>1. NÁZOV LIEKU</td><td>1. IME ZDRAVILA</td><td>1. LÄKEMEDLETS NAMN</td></tr><tr><td>200000029793</td><td>2. КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ</td><td>2. KVALITATIVNÍ A KVANTITATIVNÍ SLOŽENÍ</td><td>2. KVALITATIV OG KVANTITATIV SAMMENSÆTNING</td><td>2. QUALITATIVE UND QUANTITATIVE ZUSAMMENSETZUNG</td><td>2. ΠΟΙΟΤΙΚΗ ΚΑΙ ΠΟΣΟΤΙΚΗ ΣΥΝΘΕΣΗ</td><td>2. QUALITATIVE AND QUANTITATIVE COMPOSITION</td><td>2. COMPOSICIÓN CUALITATIVA Y CUANTITATIVA</td><td>2. KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS</td><td>2. VAIKUTTAVAT AINEET JA NIIDEN MÄÄRÄT</td><td>2. COMPOSITION QUALITATIVE ET QUANTITATIVE</td><td>2. COMHDHÉANAMH CÁILÍOCHTÚIL AGUS CAINNÍOCHTÚIL</td><td>2. KVALITATIVNI I KVANTITATIVNI SASTAV</td><td>2. MINŐSÉGI ÉS MENNYISÉGI ÖSSZETÉTEL</td><td>2. INNIHALDSLÝSING</td><td>2. COMPOSIZIONE QUALITATIVA E QUANTITATIVA</td><td>2. KOKYBINĖ IR KIEKYBINĖ SUDĖTIS</td><td>2. KVALITATĪVAIS UN KVANTITATĪVAIS SASTĀVS</td><td>2. GĦAMLA KWALITATTIVA U KWANTITATTIVA</td><td>2. KWALITATIEVE EN KWANTITATIEVE SAMENSTELLING</td><td>2. KVALITATIV OG KVANTITATIV SAMMENSETNING</td><td>2. SKŁAD JAKOŚCIOWY I ILOŚCIOWY</td><td>2. COMPOSIÇÃO QUALITATIVA E QUANTITATIVA</td><td>2. COMPOZIȚIA CALITATIVĂ ȘI CANTITATIVĂ</td><td>2. KVALITATÍVNE A KVANTITATÍVNE ZLOŽENIE</td><td>2. KAKOVOSTNA IN KOLIČINSKA SESTAVA</td><td>2. KVALITATIV OCH KVANTITATIV SAMMANSÄTTNING</td></tr><tr><td>200000029794</td><td>2.1 Общо описание</td><td>2.1 Obecný popis</td><td>2.1 Generel beskrivelse</td><td>2.1 Allgemeine Beschreibung</td><td>2.1 Γενική περιγραφή</td><td>2.1 General description</td><td>2.1 Descripción general</td><td>2.1 Üldkirjeldus</td><td>2.1 Yleiskuvaus</td><td>2.1 Description générale</td><td>2.1 Cur síos ginearálta</td><td>2.1 Opći opis</td><td>2.1 Általános leírás</td><td>2.1 Almenn lýsing</td><td>2.1 Descrizione generale</td><td>2.1 Bendras aprašymas</td><td>2.1. Vispārējs apraksts</td><td>2.1 Deskrizzjoni ġenerali</td><td>2.1 Algemene beschrijving</td><td>2.1 Generell beskrivelse</td><td>2.1 Opis ogólny</td><td>2.1 Descrição geral</td><td>2.1 Descriere generală</td><td>2.1 Všeobecný opis</td><td>2.1 Splošen opis</td><td>2.1 Allmän beskrivning</td></tr><tr><td>200000029795</td><td>2.2 Качествен и количествен състав</td><td>2.2 Kvalitativní a kvantitativní složení</td><td>2.2 Kvalitativ og kvantitativ sammensætning</td><td>2.2 Qualitative und quantitative Zusammensetzung</td><td>2.2 Ποιοτική και ποσοτική σύνθεση</td><td>2.2 Qualitative and quantitative composition</td><td>2.2 Composición cualitativa y cuantitativa</td><td>2.2 Kvalitatiivne ja kvantitatiivne koostis</td><td>2.2 Vaikuttavat aineet ja niiden määrät</td><td>2.2 Composition qualitative et quantitative</td><td>2.2 Comhdhéanamh cáilíochtúil agus cainníochtúil</td><td>2.2 Kvalitativni i kvantitativni sastav</td><td>2.2 Minőségi és mennyiségi összetétel</td><td>2.2 Innihaldslýsing</td><td>2.2 Composizione qualitativa e quantitativa</td><td>2.2 Kokybinė ir kiekybinė sudėtis</td><td>2.2. Kvalitatīvais un kvantitatīvais sastāvs</td><td>2.2. Għamla kwalitattiva u kwantitattiva</td><td>2.2 Kwalitatieve en kwantitatieve samenstelling</td><td>2.2 Kvalitativ og kvantitativ sammensetning</td><td>2.2 Skład jakościowy i ilościowy</td><td>2.2 Composição qualitativa e quantitativa</td><td>2.2 Compoziția calitativă și cantitativă</td><td>2.2 Kvalitatívne a kvantitatívne zloženie</td><td>2.2 Kakovostna in količinska sestava</td><td>2.2 Kvalitativ och kvantitativ sammansättning</td></tr><tr><td>200000029796</td><td>Помощно(и) вещество(а) с известно действие</td><td>[Pomocná látka] [Pomocné látky] se známým účinkem</td><td>Hjælpestof(fer), som behandleren skal være opmærksom på</td><td>Sonstige(r) Bestandteil(e) mit bekannter Wirkung</td><td>Έκδοχο(α) με γνωστή δράση</td><td>Excipient(s) with known effect</td><td>Excipiente(s) con efecto conocido</td><td>Teadaolevat toimet omav(ad) abiaine(d)</td><td>Apuaine(et), joiden vaikutus tunnetaan</td><td>Excipient(s) à effet notoire:</td><td>Támhán nó támháin a bhfuil éifeacht aitheanta aige nó acu</td><td>Pomoćna(e) tvar(i) s poznatim učinkom</td><td>Ismert hatású segédanyag(ok)</td><td>Hjálparefni með þekkta verkun</td><td>Eccipiente(i) con effetti noti</td><td>Pagalbinė (-s) medžiaga (-os), kurios (-ių) poveikis žinomas</td><td>Palīgviela(-s) ar zināmu iedarbību</td><td>Eċċipjent(i) b’effett magħruf</td><td>Hulpstof(fen) met bekend effect</td><td>Hjelpestoff(er) med kjent effekt</td><td>Substancja pomocnicza] [Substancje pomocnicze] o znanym działaniu</td><td>Excipiente(s) com efeito conhecido</td><td>Excipient(ți) cu efect cunoscut</td><td>[Pomocná látka] [Pomocné látky] so známym účinkom</td><td>Pomožna(e) snov(i) z znanim učinkom:</td><td>Hjälpämne(n) med känd effekt</td></tr><tr><td>200000029797</td><td>3. ЛЕКАРСТВЕНА ФОРМА</td><td>3. LÉKOVÁ FORMA</td><td>3. LÆGEMIDDELFORM</td><td>3. DARREICHUNGSFORM</td><td>3. ΦΑΡΜΑΚΟΤΕΧΝΙΚΗ ΜΟΡΦΗ</td><td>3. PHARMACEUTICAL FORM</td><td>3. FORMA FARMACÉUTICA</td><td>3. RAVIMVORM</td><td>3. LÄÄKEMUOTO</td><td>3. FORME PHARMACEUTIQUE</td><td>3. FOIRM CHÓGAISÍOCHTA</td><td>3. FARMACEUTSKI OBLIK</td><td>3. GYÓGYSZERFORMA</td><td>3. LYFJAFORM</td><td>3. FORMA FARMACEUTICA</td><td>3. FARMACINĖ FORMA</td><td>3. ZĀĻU FORMA</td><td>3. GĦAMLA FARMAĊEWTIKA</td><td>3. FARMACEUTISCHE VORM</td><td>3. LEGEMIDDELFORM</td><td>3. POSTAĆ FARMACEUTYCZNA</td><td>3. FORMA FARMACÊUTICA</td><td>3. FORMA FARMACEUTICĂ</td><td>3. LIEKOVÁ FORMA</td><td>3. FARMACEVTSKA OBLIKA</td><td>3. LÄKEMEDELSFORM</td></tr><tr><td>200000029798</td><td>4. КЛИНИЧНИ ДАННИ</td><td>4. KLINICKÉ ÚDAJE</td><td>4. KLINISKE OPLYSNINGER</td><td>4. KLINISCHE ANGABEN</td><td>4. ΚΛΙΝΙΚΕΣ ΠΛΗΡΟΦΟΡΙΕΣ</td><td>4. CLINICAL PARTICULARS</td><td>4. DATOS CLÍNICOS</td><td>4. KLIINILISED ANDMED</td><td>4. KLIINISET TIEDOT</td><td>4. INFORMATIONS CLINIQUES</td><td>4. SONRAÍ CLINICIÚLA</td><td>4. KLINIČKI PODACI</td><td>4. KLINIKAI JELLEMZŐK</td><td>4. KLÍNÍSKAR UPPLÝSINGAR</td><td>4. INFORMAZIONI CLINICHE</td><td>4. KLINIKINĖ INFORMACIJA</td><td>4. KLĪNISKĀ INFORMĀCIJA</td><td>4. TAGĦRIF KLINIKU</td><td>4. KLINISCHE GEGEVENS</td><td>4. KLINISKE OPPLYSNINGER</td><td>4. SZCZEGÓŁOWE DANE KLINICZNE</td><td>4. INFORMAÇÕES CLÍNICAS</td><td>4. DATE CLINICE</td><td>4. KLINICKÉ ÚDAJE</td><td>4. KLINIČNI PODATKI</td><td>4. KLINISKA UPPGIFTER</td></tr><tr><td>200000029799</td><td>4.1 Терапевтични показания</td><td>4.1 Terapeutické indikace</td><td>4.1 Terapeutiske indikationer</td><td>4.1 Anwendungsgebiete</td><td>4.1 Θεραπευτικές ενδείξεις</td><td>4.1 Therapeutic indications</td><td>4.1 Indicaciones terapéuticas</td><td>4.1 Näidustused</td><td>4.1 Käyttöaiheet</td><td>4.1 Indications thérapeutiques</td><td>4.1 Tásca teiripeacha</td><td>4.1 Terapijske indikacije</td><td>4.1 Terápiás javallatok</td><td>4.1 Ábendingar</td><td>4.1 Indicazioni terapeutiche</td><td>4.1 Terapinės indikacijos</td><td>4.1. Terapeitiskās indikācijas</td><td>4.1 Indikazzjonijiet terapewtiċi</td><td>4.1 Therapeutische indicaties</td><td>4.1 Indikasjon(er)</td><td>4.1 Wskazania do stosowania</td><td>4.1 Indicações terapêuticas</td><td>4.1 Indicații terapeutice</td><td>4.1 Terapeutické indikácie</td><td>4.1 Terapevtske indikacije</td><td>4.1 Terapeutiska indikationer</td></tr><tr><td>200000029800</td><td>4.2 Дозировка и начин на приложение</td><td>4.2 Dávkování a způsob podání</td><td>4.2 Dosering og administration</td><td>4.2 Dosierung und Art der Anwendung</td><td>4.2 Δοσολογία και τρόπος χορήγησης</td><td>4.2 Posology and method of administration</td><td>4.2 Posología y forma de administración</td><td>4.2 Annustamine ja manustamisviis</td><td>4.2 Annostus ja antotapa</td><td>4.2 Posologie et mode d’administration</td><td>4.2 Poseolaíocht agus modh tabhartha</td><td>4.2 Doziranje i način primjene</td><td>4.2 Adagolás és alkalmazás</td><td>4.2 Skammtar og lyfjagjöf</td><td>4.2 Posologia e modo di somministrazione</td><td>4.2 Dozavimas ir vartojimo metodas</td><td>4.2. Devas un lietošanas veids</td><td>4.2 Pożoloġija u metodu ta’ kif għandu jingħata</td><td>4.2 Dosering en wijze van toediening</td><td>4.2 Dosering og administrasjonsmåte</td><td>4.2 Dawkowanie i sposób podawania</td><td>4.2 Posologia e modo de administração</td><td>4.2 Doze și mod de administrare</td><td>4.2 Dávkovanie a spôsob podávania</td><td>4.2 Odmerjanje in način uporabe</td><td>4.2 Dosering och administreringssätt</td></tr><tr><td>200000029801</td><td>Дозировка</td><td>Dávkování</td><td>Dosering</td><td>Dosierung</td><td>Δοσολογία</td><td>Posology</td><td>Posología</td><td>Annustamine</td><td>Annostus</td><td>Posologie</td><td>Poseolaíocht</td><td>Doziranje</td><td>Adagolás</td><td>Skammtar</td><td>Posologia</td><td>Dozavimas</td><td>Devas</td><td>Pożoloġija</td><td>Dosering</td><td>Dosering</td><td>Dawkowanie</td><td>Posologia</td><td>Doze</td><td>Dávkovanie</td><td>Odmerjanje</td><td>Dosering</td></tr><tr><td>200000029802</td><td>Педиатрична популация</td><td>Pediatrická populace</td><td>Pædiatrisk population</td><td>Kinder und Jugendliche</td><td>Παιδιατρικός πληθυσμός</td><td>Paediatric population</td><td>Población pediátrica</td><td>Lapsed</td><td>Pediatriset potilaat</td><td>Population pédiatrique</td><td>Daonra péidiatrach</td><td>Pedijatrijska populacija</td><td>Gyermekek és serdülők</td><td>Börn</td><td>Popolazione pediatrica</td><td>Vaikų populiacija</td><td>Pediatriskā populācija</td><td>Popolazzjoni pedjatrika</td><td>Pediatrische patiënten</td><td>Pediatrisk populasjon</td><td>Dzieci i młodzież</td><td>População pediátrica</td><td>Copii și adolescenți</td><td>Pediatrická populácia</td><td>Pediatrična populacija</td><td>Pediatrisk population</td></tr><tr><td>200000029803</td><td>Начин на приложение</td><td>Způsob podání</td><td>Administration</td><td>Art der Anwendung</td><td>Τρόπος χορήγησης</td><td>Method of administration</td><td>Forma de administración</td><td>Manustamisviis</td><td>Antotapa</td><td>Mode d’administration</td><td>Modh tabhartha</td><td>Način primjene</td><td>Az alkalmazás módja</td><td>Lyfjagjöf</td><td>Modo di somministrazione</td><td>Vartojimo metodas</td><td>Lietošanas veids</td><td>Metodu ta’ kif għandu jingħata</td><td>Wijze van toediening</td><td>Administrasjonsmåte</td><td>Sposób podawania</td><td>Modo de administração</td><td>Mod de administrare</td><td>Spôsob podávania</td><td>Način uporabe</td><td>Administreringssätt</td></tr><tr><td>200000029804</td><td>Предпазни мерки, които трябва да бъдат взети преди работа със или приложение на лекарствения продукт</td><td>Opatření, která je nutno učinit před zacházením s léčivým přípravkem nebo před jeho podáním</td><td>Sikkerhedsforanstaltninger, der skal tages før håndtering og administration af lægemidlet</td><td>Vorsichtsmaßnahmen vor / bei der Handhabung bzw. vor / während der Anwendung des Arzneimittels</td><td>Προφυλάξεις που πρέπει να ληφθούν πριν από τον χειρισμό ή τη χορήγηση του φαρμακευτικού προϊόντος</td><td>Precautions to be taken before handling or administering the medicinal product</td><td>Precauciones que se deben tomar antes de manipular o administrar el medicamento</td><td>Enne ravimi käsitsemist või manustamist tuleb järgida ettevaatusabinõusid</td><td>Ennen lääkkeen käsittelyä tai antoa huomioon otettavat varotoimet</td><td>Précautions à prendre avant la manipulation ou l’administration du médicament</td><td>Réamhchúraimí le déanamh sula ndéantar an táirge íocshláinte a láimhsiú nó a thabhairt</td><td>Mjere opreza koje je potrebno poduzeti prije rukovanja ili primjene lijeka.</td><td>Óvintézkedések a gyógyszer felhasználása vagy alkalmazása előtt</td><td>Varúðarráðstafanir sem þarf að gera áður en lyfið er meðhöndlað eða gefið</td><td>Precauzioni che devono essere prese prima della manipolazione o della somministrazione del medicinale</td><td>Atsargumo priemonės prieš ruošiant ar vartojant šį vaistinį preparatą</td><td>Piesardzības pasākumi pirms zāļu lietošanas vai rīkošanās ar tām</td><td>Prekawzjonijiet li għandhom jittieħdu qabel tmiss il-prodott mediċinali jew qabel tagћti l-prodott mediċinali</td><td>Te nemen voorzorgen voorafgaand aan gebruik of toediening van het geneesmiddel</td><td>Forholdsregler før håndtering eller administrering av dette legemidlet</td><td>Środki ostrożności, które należy podjąć przed użyciem lub podaniem produktu leczniczego</td><td>Precauções a ter em conta antes de manusear ou administrar o medicamento</td><td>Precauții care trebuie luate înainte de manipularea sau administrarea medicamentului</td><td>Opatrenia pred zaobchádzaním alebo podaním lieku</td><td>Previdnostni ukrepi, potrebni pred ravnanjem z zdravilom ali dajanjem zdravila</td><td>Försiktighetsåtgärder före hantering eller administrering av läkemedlet</td></tr><tr><td>200000029805</td><td>4.3 Противопоказания</td><td>4.3 Kontraindikace</td><td>4.3 Kontraindikationer</td><td>4.3 Gegenanzeigen</td><td>4.3 Αντενδείξεις</td><td>4.3 Contraindications</td><td>4.3 Contraindicaciones</td><td>4.3 Vastunäidustused</td><td>4.3 Vasta-aiheet</td><td>4.3 Contre-indications</td><td>4.3 Fritásca</td><td>4.3 Kontraindikacije</td><td>4.3 Ellenjavallatok</td><td>4.3 Frábendingar</td><td>4.3 Controindicazioni</td><td>4.3 Kontraindikacijos</td><td>4.3. Kontrindikācijas</td><td>4.3 Kontraindikazzjonijiet</td><td>4.3 Contra-indicaties</td><td>4.3 Kontraindikasjoner</td><td>4.3 Przeciwwskazania</td><td>4.3 Contraindicações</td><td>4.3 Contraindicații</td><td>4.3 Kontraindikácie</td><td>4.3 Kontraindikacije</td><td>4.3 Kontraindikationer</td></tr><tr><td>200000029806</td><td>4.4 Специални предупреждения и предпазни мерки при употреба</td><td>4.4 Zvláštní upozornění a opatření pro použitív</td><td>4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen</td><td>4.4 Besondere Warnhinweise und Vorsichtsmaßnahmen für die Anwendung</td><td>4.4 Ειδικές προειδοποιήσεις και προφυλάξεις κατά τη χρήση</td><td>4.4 Special warnings and precautions for use</td><td>4.4 Advertencias y precauciones especiales de empleo</td><td>4.4 Erihoiatused ja ettevaatusabinõud kasutamisel</td><td>4.4 Varoitukset ja käyttöön liittyvät varotoimet</td><td>4.4 Mises en garde spéciales et précautions d’emploi</td><td>4.4 Rabhaidh speisialta agus réamhchúraimí úsáide</td><td>4.4 Posebna upozorenja i mjere opreza pri uporabi</td><td>4.4 Különleges figyelmeztetések és az alkalmazással kapcsolatos óvintézkedések</td><td>4.4 Sérstök varnaðarorð og varúðarreglur við notkun</td><td>4.4 Avvertenze speciali e precauzioni d’impiego</td><td>4.4 Specialūs įspėjimai ir atsargumo priemonės</td><td>4.4. Īpaši brīdinājumi un piesardzība lietošanā</td><td>4.4 Twissijiet speċjali u prekawzjonijiet għall-użu</td><td>4.4 Bijzondere waarschuwingen en voorzorgen bij gebruik</td><td>4.4 Advarsler og forsiktighetsregler</td><td>4.4 Specjalne ostrzeżenia i środki ostrożności dotyczące stosowania</td><td>4.4 Advertências e precauções especiais de utilização</td><td>4.4 Atenționări și precauții speciale pentru utilizare</td><td>4.4 Osobitné upozornenia a opatrenia pri používaní</td><td>4.4 Posebna opozorila in previdnostni ukrepi</td><td>4.4 Varningar och försiktighet</td></tr><tr><td>200000029807</td><td>Проследимост</td><td>Sledovatelnost</td><td>Sporbarhed</td><td>Rückverfolgbarkeit</td><td>Ιχνηλασιμότητα</td><td>Traceability</td><td>Trazabilidad</td><td>Jälgitavus</td><td>Jäljitettävyys</td><td>Traçabilité</td><td>Inrianaitheacht</td><td>Sljedivost</td><td>Nyomonkövethetőség</td><td>Rekjanleiki</td><td>Tracciabilità</td><td>Atsekamumas</td><td>Izsekojamība</td><td>Traċċabilità</td><td>Terugvinden herkomst</td><td>Sporbarhet</td><td>Identyfikowalność</td><td>Rastreabilidade</td><td>Trasabilitate</td><td>Sledovateľnosť</td><td>Sledljivost</td><td>Spårbarhet</td></tr><tr><td>200000029808</td><td>Педиатрична популация</td><td>Pediatrická populace</td><td>Pædiatrisk population</td><td>Kinder und Jugendliche</td><td>Παιδιατρικός πληθυσμός</td><td>Paediatric population</td><td>Población pediátrica</td><td>Lapsed</td><td>Pediatriset potilaat</td><td>Population pédiatrique</td><td>Daonra péidiatrach</td><td>Pedijatrijska populacija</td><td>Gyermekek és serdülők</td><td>Börn</td><td>Popolazione pediatrica</td><td>Vaikų populiacija</td><td>Pediatriskā populācija</td><td>Popolazzjoni pedjatrika</td><td>Pediatrische patiënten</td><td>Pediatrisk populasjon</td><td>Dzieci i młodzież</td><td>População pediátrica</td><td>Copii și adolescenți</td><td>Pediatrická populácia</td><td>Pediatrična populacija</td><td>Pediatrisk population</td></tr><tr><td>200000029809</td><td>4.5 Взаимодействие с други лекарствени продукти и други форми на взаимодействие</td><td>4.5 Interakce s jinými léčivými přípravky a jiné formy interakce</td><td>4.5 Interaktion med andre lægemidler og andre former for interaktion</td><td>4.5 Wechselwirkungen mit anderen Arzneimitteln und sonstige Wechselwirkungen</td><td>4.5 Αλληλεπιδράσεις με άλλα φαρμακευτικά προϊόντα και άλλες μορφές αλληλεπίδρασης</td><td>4.5 Interaction with other medicinal products and other forms of interaction</td><td>4.5 Interacción con otros medicamentos y otras formas de interacción</td><td>4.5 Koostoimed teiste ravimitega ja muud koostoimed</td><td>4.5 Yhteisvaikutukset muiden lääkevalmisteiden kanssa sekä muut yhteisvaikutukset</td><td>4.5 Interactions avec d’autres médicaments et autres formes d’interactions</td><td>4.5 Idirghníomhaíocht le táirgí íocshláinte eile agus cineálacha eile idirghníomhaíochta</td><td>4.5 Interakcije s drugim lijekovima i drugi oblici interakcija</td><td>4.5 Gyógyszerkölcsönhatások és egyéb interakciók</td><td>4.5 Milliverkanir við önnur lyf og aðrar milliverkanir</td><td>4.5 Interazioni con altri medicinali ed altre forme d’interazione</td><td>4.5 Sąveika su kitais vaistiniais preparatais ir kitokia sąveika</td><td>4.5. Mijiedarbība ar citām zālēm un citi mijiedarbības veidi</td><td>4.5 Interazzjoni ma’ prodotti mediċinali oħra u forom oħra ta’ interazzjoni</td><td>4.5 Interacties met andere geneesmiddelen en andere vormen van interactie</td><td>4.5 Interaksjon med andre legemidler og andre former for interaksjon</td><td>4.5 Interakcje z innymi produktami leczniczymi i inne rodzaje interakcji</td><td>4.5 Interações medicamentosas e outras formas de interação</td><td>4.5 Interacțiuni cu alte medicamente și alte forme de interacțiune</td><td>4.5 Liekové a iné interakcie</td><td>4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij</td><td>4.5 Interaktioner med andra läkemedel och övriga interaktioner</td></tr><tr><td>200000029810</td><td>Педиатрична популация</td><td>Pediatrická populace</td><td>Pædiatrisk population</td><td>Kinder und Jugendliche</td><td>Παιδιατρικός πληθυσμός</td><td>Paediatric population</td><td>Población pediátrica</td><td>Lapsed</td><td>Pediatriset potilaat</td><td>Population pédiatrique</td><td>Daonra péidiatrach</td><td>Pedijatrijska populacija</td><td>Gyermekek és serdülők</td><td>Börn</td><td>Popolazione pediatrica</td><td>Vaikų populiacija</td><td>Pediatriskā populācija</td><td>Popolazzjoni pedjatrika</td><td>Pediatrische patiënten</td><td>Pediatrisk populasjon</td><td>Dzieci i młodzież</td><td>População pediátrica</td><td>Copii și adolescenți</td><td>Pediatrická populácia</td><td>Pediatrična populacija</td><td>Pediatrisk population</td></tr><tr><td>200000029811</td><td>4.6 Фертилитет, бременност и кърмене</td><td>4.6 Fertilita, těhotenství a kojení</td><td>4.6 Fertilitet, graviditet og amning</td><td>4.6 Fertilität, Schwangerschaft und Stillzeit</td><td>4.6 Γονιμότητα, κύηση και γαλουχία</td><td>4.6 Fertility, pregnancy and lactation</td><td>4.6 Fertilidad, embarazo y lactancia</td><td>4.6 Fertiilsus, rasedus ja imetamine</td><td>4.6 Hedelmällisyys, raskaus ja imetys</td><td>4.6 Fertilité, grossesse et allaitement</td><td>4.6 Torthúlacht, toircheas agus lachtadh</td><td>4.6 Plodnost, trudnoća i dojenje</td><td>4.6 Termékenység, terhesség és szoptatás</td><td>4.6 Frjósemi, meðganga og brjóstagjöf</td><td>4.6 Fertilità, gravidanza e allattamento</td><td>4.6 Vaisingumas, nėštumo ir žindymo laikotarpis</td><td>4.6. Fertilitāte, grūtniecība un barošana ar krūti</td><td>4.6 Fertilità, tqala u treddigħ</td><td>4.6 Vruchtbaarheid, zwangerschap en borstvoeding</td><td>4.6 Fertilitet, graviditet og amming</td><td>4.6 Wpływ na płodność, ciążę i laktację</td><td>4.6 Fertilidade, gravidez e aleitamento</td><td>4.6 Fertilitatea, sarcina și alăptarea</td><td>4.6 Fertilita, gravidita a laktácia</td><td>4.6 Plodnost, nosečnost in dojenje</td><td>4.6 Fertilitet, graviditet och amning</td></tr><tr><td>200000029812</td><td>Бременност</td><td>Těhotenství</td><td>Graviditet</td><td>Schwangerschaft</td><td>Κύηση</td><td>Pregnancy</td><td>Embarazo</td><td>Rasedus</td><td>Raskaus</td><td>Grossesse</td><td>Toircheas</td><td>Trudnoća</td><td>Terhesség</td><td>Meðganga</td><td>Gravidanza</td><td>Nėštumas</td><td>Grūtniecība</td><td>Tqala</td><td>Zwangerschap</td><td>Graviditet</td><td>Ciąża</td><td>Gravidez</td><td>Sarcina</td><td>Gravidita</td><td>Nosečnost</td><td>Graviditet</td></tr><tr><td>200000029813</td><td>Кърмене</td><td>Kojení</td><td>Amning</td><td>Stillzeit</td><td>Θηλασμός</td><td>Breast-feeding</td><td>Lactancia</td><td>Imetamine</td><td>Imetys</td><td>Allaitement</td><td>Beathú cíche</td><td>Dojenje</td><td>Szoptatás</td><td>Brjóstagjöf</td><td>Allattamento</td><td>Žindymas</td><td>Barošana ar krūti</td><td>Treddigħ</td><td>Borstvoeding</td><td>Amming</td><td>Karmienie piersią</td><td>Amamentação</td><td>Alăptarea</td><td>Dojčenie</td><td>Dojenje</td><td>Amning</td></tr><tr><td>200000029814</td><td>Фертилитет</td><td>Fertilita</td><td>Fertilitet</td><td>Fertilität</td><td>Γονιμότητα</td><td>Fertility</td><td>Fertilidad</td><td>Fertiilsus</td><td>Hedelmällisyys</td><td>Fertilité</td><td>Torthúlacht</td><td>Plodnost</td><td>Termékenység</td><td>Frjósemi</td><td>Fertilità</td><td>Vaisingumas</td><td>Fertilitāte</td><td>Fertilità</td><td>Vruchtbaarheid</td><td>Fertilitet</td><td>Płodność</td><td>Fertilidade</td><td>Fertilitatea</td><td>Fertilita</td><td>Plodnost</td><td>Fertilitet</td></tr><tr><td>200000029815</td><td>4.7 Ефекти върху способността за шофиране и работа с машини</td><td>4.7 Účinky na schopnost řídit a obsluhovat stroje</td><td>4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner</td><td>4.7 Auswirkungen auf die Verkehrstüchtigkeit und die Fähigkeit zum Bedienen von Maschinen</td><td>4.7 Επιδράσεις στην ικανότητα οδήγησης και χειρισμού μηχανημάτων</td><td>4.7 Effects on ability to drive and use machines</td><td>4.7 Efectos sobre la capacidad para conducir y utilizar máquinas</td><td>4.7 Toime reaktsioonikiirusele</td><td>4.7 Vaikutus ajokykyyn ja koneidenkäyttökykyyn</td><td>4.7 Effets sur l’aptitude à conduire des véhicules et à utiliser des machines</td><td>4.7 Éifeachtaí ar an gcumas tiomána agus úsáide inneall</td><td>4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima</td><td>4.7 A készítmény hatásai a gépjárművezetéshez és a gépek kezeléséhez szükséges képességekre</td><td>4.7 Áhrif á hæfni til aksturs og notkunar véla</td><td>4.7 Effetti sulla capacità di guidare veicoli e sull’uso di macchinari</td><td>4.7 Poveikis gebėjimui vairuoti ir valdyti mechanizmus</td><td>4.7. Ietekme uz spēju vadīt transportlīdzekļus un apkalpot mehānismus</td><td>4.7 Effetti fuq il-ħila biex issuq u tħaddem magni</td><td>4.7 Beïnvloeding van de rijvaardigheid en het vermogen om machines te bedienen</td><td>4.7 Påvirkning av evnen til å kjøre bil og bruke maskiner</td><td>4.7 Wpływ na zdolność prowadzenia pojazdów i obsługiwania maszyn</td><td>4.7 Efeitos sobre a capacidade de conduzir e utilizar máquinas</td><td>4.7 Efecte asupra capacității de a conduce vehicule și de a folosi utilaje</td><td>4.7 Ovplyvnenie schopnosti viesť vozidlá a obsluhovať stroje</td><td>4.7 Vpliv na sposobnost vožnje in upravljanja strojev</td><td>4.7 Effekter på förmågan att framföra fordon och använda maskiner</td></tr><tr><td>200000029816</td><td>4.8 Нежелани лекарствени реакции</td><td>4.8 Nežádoucí účinky</td><td>4.8 Bivirkninger</td><td>4.8 Nebenwirkungen</td><td>4.8 Ανεπιθύμητες ενέργειες</td><td>4.8 Undesirable effects</td><td>4.8 Reacciones adversas</td><td>4.8 Kõrvaltoimed</td><td>4.8 Haittavaikutukset</td><td>4.8 Effets indésirables</td><td>4.8 Éifeachtaí neamh-inmhianaithe</td><td>4.8 Nuspojave</td><td>4.8 Nemkívánatos hatások, mellékhatások</td><td>4.8 Aukaverkanir</td><td>4.8 Effetti indesiderati</td><td>4.8 Nepageidaujamas poveikis</td><td>4.8. Nevēlamās blakusparādības</td><td>4.8 Effetti mhux mixtieqa</td><td>4.8 Bijwerkingen</td><td>4.8 Bivirkninger</td><td>4.8 Działania niepożądane</td><td>4.8 Efeitos indesejáveis</td><td>4.8 Reacții adverse</td><td>4.8 Nežiaduce účinky</td><td>4.8 Neželeni učinki</td><td>4.8 Biverkningar</td></tr><tr><td>200000029817</td><td>Педиатрична популация</td><td>Pediatrická populace</td><td>Pædiatrisk population</td><td>Kinder und Jugendliche</td><td>Παιδιατρικός πληθυσμός</td><td>Paediatric population</td><td>Población pediátrica</td><td>Lapsed</td><td>Pediatriset potilaat</td><td>Population pédiatrique</td><td>Daonra péidiatrach</td><td>Pedijatrijska populacija</td><td>Gyermekek és serdülők</td><td>Börn</td><td>Popolazione pediatrica</td><td>Vaikų populiacija</td><td>Pediatriskā populācija</td><td>Popolazzjoni pedjatrika</td><td>Pediatrische patiënten</td><td>Pediatrisk populasjon</td><td>Dzieci i młodzież</td><td>População pediátrica</td><td>Copii și adolescenți</td><td>Pediatrická populácia</td><td>Pediatrična populacija</td><td>Pediatrisk population</td></tr><tr><td>200000029818</td><td>Съобщаване на подозирани нежелани реакции</td><td>Hlášení podezření na nežádoucí účinky</td><td>Indberetning af formodede bivirkninger</td><td>Meldung des Verdachts auf Nebenwirkungen</td><td>Αναφορά πιθανολογούμενων ανεπιθύμητων ενεργειών</td><td>Reporting of suspected adverse reactions</td><td>Notificación de sospechas de reacciones adversas</td><td>Võimalikest kõrvaltoimetest teatamine</td><td>Epäillyistä haittavaikutuksista ilmoittaminen</td><td>Déclaration des effets indésirables suspectés</td><td>Tuairisciú ar fhrithghníomhartha díobhálacha amhrasta</td><td>Prijavljivanje sumnji na nuspojavu</td><td>Feltételezett mellékhatások bejelentése</td><td>Tilkynning aukaverkana sem grunur er um að tengist lyfinu</td><td>Segnalazione delle reazioni avverse sospette</td><td>Pranešimas apie įtariamas nepageidaujamas reakcijas</td><td>Ziņošana par iespējamām nevēlamām blakusparādībām</td><td>Rappurtar ta’ reazzjonijiet avversi suspettati</td><td>Melding van vermoedelijke bijwerkingen</td><td>Melding av mistenkte bivirkninger</td><td>Zgłaszanie podejrzewanych działań niepożądanych</td><td>Notificação de suspeitas de reações adversas</td><td>Raportarea reacțiilor adverse suspectate</td><td>Hlásenie podozrení na nežiaduce reakcie</td><td>Poročanje o domnevnih neželenih učinkih</td><td>Rapportering av misstänkta biverkningar</td></tr><tr><td>200000029819</td><td>4.9 Предозиране</td><td>4.9 Předávkování</td><td>4.9 Overdosering</td><td>4.9 Überdosierung</td><td>4.9 Υπερδοσολογία</td><td>4.9 Overdose</td><td>4.9 Sobredosis</td><td>4.9 Üleannustamine</td><td>4.9 Yliannostus</td><td>4.9 Surdosage</td><td>4.9 Ródháileog</td><td>4.9 Predoziranje</td><td>4.9 Túladagolás</td><td>4.9 Ofskömmtun</td><td>4.9 Sovradosaggio</td><td>4.9 Perdozavimas</td><td>4.9. Pārdozēšana</td><td>4.9 Doża eċċessiva</td><td>4.9 Overdosering</td><td>4.9 Overdosering</td><td>4.9 Przedawkowanie</td><td>4.9 Sobredosagem</td><td>4.9 Supradozaj</td><td>4.9 Predávkovanie</td><td>4.9 Preveliko odmerjanje</td><td>4.9 Överdosering</td></tr><tr><td>200000029820</td><td>Педиатрична популация</td><td>Pediatrická populace</td><td>Pædiatrisk population</td><td>Kinder und Jugendliche</td><td>Παιδιατρικός πληθυσμός</td><td>Paediatric population</td><td>Población pediátrica</td><td>Lapsed</td><td>Pediatriset potilaat</td><td>Population pédiatrique</td><td>Daonra péidiatrach</td><td>Pedijatrijska populacija</td><td>Gyermekek és serdülők</td><td>Börn</td><td>Popolazione pediatrica</td><td>Vaikų populiacija</td><td>Pediatriskā populācija</td><td>Popolazzjoni pedjatrika</td><td>Pediatrische patiënten</td><td>Pediatrisk populasjon</td><td>Dzieci i młodzież</td><td>População pediátrica</td><td>Copii și adolescenți</td><td>Pediatrická populácia</td><td>Pediatrična populacija</td><td>Pediatrisk population</td></tr><tr><td>200000029821</td><td>5. ФАРМАКОЛОГИЧНИ СВОЙСТВА</td><td>5. FARMAKOLOGICKÉ VLASTNOSTI</td><td>5. FARMAKOLOGISKE EGENSKABER</td><td>5. PHARMAKOLOGISCHE EIGENSCHAFTEN</td><td>5. ΦΑΡΜΑΚΟΛΟΓΙΚΕΣ ΙΔΙΟΤΗΤΕΣ</td><td>5. PHARMACOLOGICAL PROPERTIES</td><td>5. PROPIEDADES FARMACOLÓGICAS</td><td>5. FARMAKOLOOGILISED OMADUSED</td><td>5. FARMAKOLOGISET OMINAISUUDET</td><td>5. PROPRIÉTÉS PHARMACOLOGIQUES</td><td>5. AIRÍONNA CÓGASEOLAÍOCHA</td><td>5. FARMAKOLOŠKA SVOJSTVA</td><td>5. FARMAKOLÓGIAI TULAJDONSÁGOK</td><td>5. LYFJAFRÆÐILEGAR UPPLÝSINGAR</td><td>5. PROPRIETÀ FARMACOLOGICHE</td><td>5. FARMAKOLOGINĖS SAVYBĖS</td><td>5. FARMAKOLOĢISKĀS ĪPAŠĪBAS</td><td>5. PROPRJETAJIET FARMAKOLOĠIĊI</td><td>5. FARMACOLOGISCHE EIGENSCHAPPEN</td><td>5. FARMAKOLOGISKE EGENSKAPER</td><td>5. WŁAŚCIWOŚCI FARMAKOLOGICZNE</td><td>5. PROPRIEDADES FARMACOLÓGICAS</td><td>5. PROPRIETĂȚI FARMACOLOGICE</td><td>5. FARMAKOLOGICKÉ VLASTNOSTI</td><td>5. FARMAKOLOŠKE LASTNOSTI</td><td>5. FARMAKOLOGISKA EGENSKAPER</td></tr><tr><td>200000029822</td><td>5.1 Фармакодинамични свойства</td><td>5.1 Farmakodynamické vlastnosti</td><td>5.1 Farmakodynamiske egenskaber</td><td>5.1 Pharmakodynamische Eigenschaften</td><td>5.1 Φαρμακοδυναμικές ιδιότητες</td><td>5.1 Pharmacodynamic properties</td><td>5.1 Propiedades farmacodinámicas</td><td>5.1 Farmakodünaamilised omadused</td><td>5.1 Farmakodynamiikka</td><td>5.1 Propriétés pharmacodynamiques</td><td>5.1 Airíonna cógasdinimiciúla</td><td>5.1 Farmakodinamička svojstva</td><td>5.1 Farmakodinámiás tulajdonságok</td><td>5.1 Lyfhrif</td><td>5.1 Proprietà farmacodinamiche</td><td>5.1 Farmakodinaminės savybės</td><td>5.1. Farmakodinamiskās īpašības</td><td>5.1 Proprjetajiet farmakodinamiċi</td><td>5.1 Farmacodynamische eigenschappen</td><td>5.1 Farmakodynamiske egenskaper</td><td>5.1 Właściwości farmakodynamiczne</td><td>5.1 Propriedades farmacodinâmicas</td><td>5.1 Proprietăți farmacodinamice</td><td>5.1 Farmakodynamické vlastnosti</td><td>5.1 Farmakodinamične lastnosti</td><td>5.1 Farmakodynamiska egenskaper</td></tr><tr><td>200000029823</td><td>Механизъм на действие</td><td>Mechanismus účinku</td><td>Virkningsmekanisme</td><td>Wirkmechanismus</td><td>Μηχανισμός δράσης</td><td>Mechanism of action</td><td>Mecanismo de acción</td><td>Toimemehhanism</td><td>Vaikutusmekanismi</td><td>Mécanisme d’action</td><td>Meicníocht gníomhaíochta</td><td>Mehanizam djelovanja</td><td>Hatásmechanizmus</td><td>Verkunarháttur</td><td>Meccanismo d’azione</td><td>Veikimo mechanizmas</td><td>Darbības mehānisms</td><td>Mekkaniżmu ta’ azzjoni</td><td>Werkingsmechanisme</td><td>Virkningsmekanisme</td><td>Mechanizm działania</td><td>Mecanismo de ação</td><td>Mecanism de acțiune</td><td>Mechanizmus účinku</td><td>Mehanizem delovanja</td><td>Verkningsmekanism</td></tr><tr><td>200000029824</td><td>Фармакодинамични ефекти</td><td>Farmakodynamické účinky</td><td>Farmakodynamisk virkning</td><td>Pharmakodynamische Wirkungen</td><td>Φαρμακοδυναμικές επιδράσεις</td><td>Pharmacodynamic effects</td><td>Efectos farmacodinámicos</td><td>Farmakodünaamilised toimed</td><td>Farmakodynaamiset vaikutukset</td><td>Effets pharmacodynamiques</td><td>Éifeachtaí cógasdinimiciúla</td><td>Farmakodinamički učinci</td><td>Farmakodinámiás hatások</td><td>Lyfhrif</td><td>Effetti farmacodinamici</td><td>Farmakodinaminis poveikis</td><td>Farmakodinamiskā iedarbība</td><td>Effetti farmakodinamiċi</td><td>Farmacodynamische effecten</td><td>Farmakodynamiske effekter</td><td>Działanie farmakodynamiczne</td><td>Efeitos farmacodinâmicos</td><td>Efecte farmacodinamice</td><td>Farmakodynamické účinky</td><td>Farmakodinamični učinki</td><td>Farmakodynamisk effekt</td></tr><tr><td>200000029825</td><td>Клинична ефикасност и безопасност</td><td>Klinická účinnost a bezpečnost</td><td>Klinisk virkning og sikkerhed</td><td>Klinische Wirksamkeit und Sicherheit</td><td>Κλινική αποτελεσματικότητα και ασφάλεια</td><td>Clinical efficacy and safety</td><td>Eficacia clínica y seguridad</td><td>Kliiniline efektiivsus ja ohutus</td><td>Kliininen teho ja turvallisuus</td><td>Efficacité et sécurité cliniques</td><td>Éifeachtúlacht chliniciúil agus sábháilteacht</td><td>Klinička djelotvornost i sigurnost</td><td>Klinikai hatásosság és biztonságosság</td><td>Verkun og öryggi</td><td>Efficacia e sicurezza clinica</td><td>Klinikinis veiksmingumas ir saugumas</td><td>Klīniskā efektivitāte un drošums</td><td>Effikaċja klinika u sigurtà</td><td>Klinische werkzaamheid en veiligheid</td><td>Klinisk effekt og sikkerhet</td><td>Skuteczność kliniczna i bezpieczeństwo stosowania</td><td>Eficácia e segurança clínicas</td><td>Eficacitate și siguranță clinică</td><td>Klinická účinnosť a bezpečnosť</td><td>Klinična učinkovitost in varnost</td><td>Klinisk effekt och säkerhet</td></tr><tr><td>200000029826</td><td>Педиатрична популация</td><td>Pediatrická populace</td><td>Pædiatrisk population</td><td>Kinder und Jugendliche</td><td>Παιδιατρικός πληθυσμός</td><td>Paediatric population</td><td>Población pediátrica</td><td>Lapsed</td><td>Pediatriset potilaat</td><td>Population pédiatrique</td><td>Daonra péidiatrach</td><td>Pedijatrijska populacija</td><td>Gyermekek és serdülők</td><td>Börn</td><td>Popolazione pediatrica</td><td>Vaikų populiacija</td><td>Pediatriskā populācija</td><td>Popolazzjoni pedjatrika</td><td>Pediatrische patiënten</td><td>Pediatrisk populasjon</td><td>Dzieci i młodzież</td><td>População pediátrica</td><td>Copii și adolescenți</td><td>Pediatrická populácia</td><td>Pediatrična populacija</td><td>Pediatrisk population</td></tr><tr><td>200000029827</td><td>5.2 Фармакокинетични свойства</td><td>5.2 Farmakokinetické vlastnosti</td><td>5.2 Farmakokinetiske egenskaber</td><td>5.2 Pharmakokinetische Eigenschaften</td><td>5.2 Φαρμακοκινητικές ιδιότητες</td><td>5.2 Pharmacokinetic properties</td><td>5.2 Propiedades farmacocinéticas</td><td>5.2 Farmakokineetilised omadused</td><td>5.2 Farmakokinetiikka</td><td>5.2 Propriétés pharmacocinétiques</td><td>5.2 Airíonna cógaschinéiteacha</td><td>5.2 Farmakokinetička svojstva</td><td>5.2 Farmakokinetikai tulajdonságok</td><td>5.2 Lyfjahvörf</td><td>5.2 Proprietà farmacocinetiche</td><td>5.2 Farmakokinetinės savybėsv</td><td>5.2. Farmakokinētiskās īpašības</td><td>5.2 Tagħrif farmakokinetiku</td><td>5.2 Farmacokinetische eigenschappen</td><td>5.2 Farmakokinetiske egenskaper</td><td>5.2 Właściwości farmakokinetyczne</td><td>5.2 Propriedades farmacocinéticas</td><td>5.2 Proprietăți farmacocinetice</td><td>5.2 Farmakokinetické vlastnosti</td><td>5.2 Farmakokinetične lastnosti</td><td>5.2 Farmakokinetiska egenskaper</td></tr><tr><td>200000029828</td><td>Абсорбция</td><td>Absorpce</td><td>Absorption</td><td>Resorption</td><td>Απορρόφηση</td><td>Absorption</td><td>Absorción</td><td>Imendumine</td><td>Imeytyminen</td><td>Absorption</td><td>Ionsú</td><td>Apsorpcija</td><td>Felszívódás</td><td>Frásog</td><td>Assorbimento</td><td>Absorbcija</td><td>Uzsūkšanā</td><td>Assorbiment</td><td>Absorptie</td><td>Absorpsjon</td><td>Wchłanianie</td><td>Absorção</td><td>Absorbție</td><td>Absorpcia</td><td>Absorpcija</td><td>Absorption</td></tr><tr><td>200000029829</td><td>Разпределение</td><td>Distribuce</td><td>Fordeling</td><td>Verteilung</td><td>Κατανομή</td><td>Distribution</td><td>Distribución</td><td>Jaotumine</td><td>Jakautuminen</td><td>Distribution</td><td>Dáileachán</td><td>Distribucija</td><td>Eloszlás</td><td>Dreifing</td><td>Distribuzione</td><td>Pasiskirstymas</td><td>Izkliede</td><td>Distribuzzjoni</td><td>Distributie</td><td>Distribusjon</td><td>Dystrybucja</td><td>Distribuição</td><td>Distribuție</td><td>Distribúcia</td><td>Porazdelitev</td><td>Distribution</td></tr><tr><td>200000029830</td><td>Биотрансформация</td><td>Biotransformace</td><td>Biotransformation</td><td>Biotransformation</td><td>Βιομετασχηματισμός</td><td>Biotransformation</td><td>Biotransformación</td><td>Biotransformatsioon</td><td>Biotransformaatio</td><td>Biotransformation</td><td>Bithchlaochlú</td><td>Biotransformacija</td><td>Biotranszformáció</td><td>Umbrot</td><td>Biotrasformazione</td><td>Biotransformacija</td><td>Biotransformācija</td><td>Bijotrasformazzjoni</td><td>Biotransformatie</td><td>Biotransformasjon</td><td>Metabolizm</td><td>Biotransformação</td><td>Metabolizare</td><td>Biotransformácia</td><td>Biotransformacija</td><td>Metabolism</td></tr><tr><td>200000029831</td><td>Елиминиране</td><td>Eliminace</td><td>Elimination</td><td>Elimination</td><td>Αποβολή</td><td>Elimination</td><td>Eliminación</td><td>Eritumine</td><td>Eliminaatio</td><td>Élimination</td><td>Díbirt</td><td>Eliminacija</td><td>Elimináció</td><td>Brotthvarf</td><td>Eliminazione</td><td>Eliminacija</td><td>Eliminācija</td><td>Eliminazzjoni</td><td>Eliminatie</td><td>Eliminasjon</td><td>Eliminacja</td><td>Eliminação</td><td>Eliminare</td><td>Eliminácia</td><td>Izločanje</td><td>Eliminering</td></tr><tr><td>200000029832</td><td>Линейност/нелинейност</td><td>Linearita/nelinearita</td><td>Linearitet/non-linearitet</td><td>Linearität/Nicht-Linearität</td><td>Γραμμικότητα/μη γραμμικότητα</td><td>Linearity/non-linearity</td><td>Linealidad/No linealidad</td><td>Lineaarsus/mittelineaarsus</td><td>Lineaarisuus/ei-lineaarisuus</td><td>Linéarité/non-linéarité</td><td>Líneacht/neamhlíneacht</td><td>Linearnost/nelinearnost</td><td>Linearitás/nonlinearitás</td><td>Línulegt/ólínulegt samband</td><td>Linearità/Non linearità</td><td>Tiesinis / netiesinis pobūdis</td><td>Linearitāte/nelinearitāte</td><td>Linearità/nuqqas ta’ linearità</td><td>Lineariteit/non-lineariteit</td><td>Linearitet/ikke-linearitet</td><td>Liniowość lub nieliniowość</td><td>Linearidade/não linearidade</td><td>Liniaritate/Non-liniaritate</td><td>Linearita/nelinearita</td><td>Linearnost/nelinearnost</td><td>Linjäritet/icke-linjäritet</td></tr><tr><td>200000029833</td><td>Връзка(и) фармакокинетика-фармакодинамика</td><td>Farmakokinetické/farmakodynamické vztahy</td><td>Farmakokinetiske/farmakodynamiske forhold</td><td>Pharmakokinetische/pharmakodynamische Zusammenhänge</td><td>Φαρμακοκινητικές/φαρμακοδυναμικές σχέσεις</td><td>Pharmacokinetic/pharmacodynamic relationship(s)</td><td>Relación(es) farmacocinéticas/farmacodinámica(s)</td><td>Farmakokineetilised/farmakodünaamilised toimed</td><td>Farmakokineettiset/farmakodynaamiset suhteet</td><td>Relations pharmacocinétique/pharmacodynamique</td><td>Caidreamh cógaschinéiteach/cógasdinimiciúil</td><td>Farmakokinetički/farmakodinamički odnos(i)</td><td>Farmakokinetikai/farmakodinámiás összefüggés(ek)</td><td>Tengsl lyfjahvarfa og lyfhrifa</td><td>Relazione(i) farmacocinetica(che)/farmacodinamica(che)</td><td>Santykis tarp farmakokinetikos ir farmakodinamikos</td><td>Farmakokinētiskā(-s)/farmakodinamiskā(-s) attiecība(-s)</td><td>Relazzjoni(-jiet) farmakokinetika(ċi)/farmakodinamika(ċi)</td><td>Farmacokinetische/farmacodynamische relatie(s)</td><td>Farmakokinetiske/farmakodynamiske forhold</td><td>Zależności farmakokinetyczno-farmakodynamiczne</td><td>Relação(ões) farmacocinética/farmacodinâmica</td><td>Relație(i) farmacocinetică(e)/farmacodinamică(e)</td><td>Farmakokinetický/farmakodynamický vzťah</td><td>Farmakokinetično/farmakodinamično razmerje</td><td>Farmakokinetiskt (Farmakokinetiska)/farmakodynamiskt (farmakodynamiska) förhållande(n)</td></tr><tr><td>200000029834</td><td>5.3 Предклинични данни за безопасност</td><td>5.3 Předklinické údaje vztahující se k bezpečnosti</td><td>5.3 Non-kliniske sikkerhedsdata</td><td>5.3 Präklinische Daten zur Sicherheit</td><td>5.3 Προκλινικά δεδομένα για την ασφάλεια</td><td>5.3 Preclinical safety data</td><td>5.3 Datos preclínicos sobre seguridad</td><td>5.3 Prekliinilised ohutusandmedv</td><td>5.3 Prekliiniset tiedot turvallisuudesta</td><td>5.3 Données de sécurité préclinique</td><td>5.3 Sonraí sábháilteachta réamhchliniciúla</td><td>5.3 Neklinički podaci o sigurnosti primjene</td><td>5.3 A preklinikai biztonságossági vizsgálatok eredményei</td><td>5.3 Forklínískar upplýsingar</td><td>5.3 Dati preclinici di sicurezza</td><td>5.3 Ikiklinikinių saugumo tyrimų duomenys</td><td>5.3. Preklīniskie dati par drošumu</td><td>5.3 Tagħrif ta' qabel l-użu kliniku dwar is-sigurtà</td><td>5.3 Gegevens uit het preklinisch veiligheidsonderzoek</td><td>5.3 Prekliniske sikkerhetsdata</td><td>5.3 Przedkliniczne dane o bezpieczeństwie</td><td>5.3 Dados de segurança pré-clínica</td><td>5.3 Date preclinice de siguranță</td><td>5.3 Predklinické údaje o bezpečnosti</td><td>5.3 Predklinični podatki o varnosti</td><td>5.3 Prekliniska säkerhetsuppgifter</td></tr><tr><td>200000029835</td><td>Оценка на риска за околната среда (ERA)</td><td>Posouzení rizika pro životní prostředí</td><td>Miljørisikovurdering</td><td>Beurteilung der Risiken für die Umwelt (Environmental risk assessment [ERA])</td><td>Αξιολόγηση περιβαλλοντικού κινδύνου</td><td>Environmental risk assessment (ERA)</td><td>Evaluación del riesgo medioambiental (ERA, por sus siglas en inglés)</td><td>Keskkonnariski hindamine</td><td>Ympäristöön kohdistuvien riskien arviointi</td><td>Évaluation du risque environnemental</td><td>Measúnú riosca don chomhshaoil (MRC)</td><td>Procjena rizika za okoliš (ERA)</td><td>Becsült környezeti kockázat</td><td>Mat á áhættu fyrir lífríkið</td><td>Valutazione del rischio ambientale (Environmental risk assessment, ERA)</td><td>Pavojaus aplinkai vertinimas (PAV)</td><td>Vides riska novērtējums (VRN)</td><td>Valutazzjoni tar-riskju ambjentali (ERA)</td><td>Environmental Risk Assessment (ERA)</td><td>Evaluering av miljørisiko (Environmental risk assessment, ERA)</td><td>Ocena ryzyka dla środowiska</td><td>Avaliação do risco ambiental (ARA)</td><td>Evaluarea riscului de mediu (ERM)</td><td>Hodnotenie environmentálneho rizika (ERA)</td><td>Ocena tveganja za okolje</td><td>Miljöriskbedömning</td></tr><tr><td>200000029836</td><td>6. ФАРМАЦЕВТИЧНИ ДАННИ</td><td>6. FARMACEUTICKÉ ÚDAJE</td><td>6. FARMACEUTISKE OPLYSNINGER</td><td>6. PHARMAZEUTISCHE ANGABEN</td><td>6. ΦΑΡΜΑΚΕΥΤΙΚΕΣ ΠΛΗΡΟΦΟΡΙΕΣ</td><td>6. PHARMACEUTICAL PARTICULARS</td><td>6. DATOS FARMACÉUTICOS</td><td>6. FARMATSEUTILISED ANDMED</td><td>6. FARMASEUTTISET TIEDOT</td><td>6. DONNÉES PHARMACEUTIQUES</td><td>6. SONRAÍ CÓGAISÍOCHTA</td><td>6. FARMACEUTSKI PODACI</td><td>6. GYÓGYSZERÉSZETI JELLEMZŐK</td><td>6. LYFJAGERÐARFRÆÐILEGAR UPPLÝSINGAR</td><td>6. INFORMAZIONI FARMACEUTICHE</td><td>6. FARMACINĖ INFORMACIJA</td><td>6. FARMACEITISKĀ INFORMĀCIJA</td><td>6. TAGĦRIF FARMAĊEWTIKU</td><td>6. FARMACEUTISCHE GEGEVENS</td><td>6. FARMASØYTISKE OPPLYSNINGER</td><td>6. DANE FARMACEUTYCZNE</td><td>6. INFORMAÇÕES FARMACÊUTICAS</td><td>6. PROPRIETĂȚI FARMACEUTICE</td><td>6. FARMACEUTICKÉ INFORMÁCIE</td><td>6. FARMACEVTSKI PODATKI</td><td>6. FARMACEUTISKA UPPGIFTER</td></tr><tr><td>200000029837</td><td>6.1 Списък на помощните вещества</td><td>6.1 Seznam pomocných látek</td><td>6.1 Hjælpestoffer</td><td>6.1 Liste der sonstigen Bestandteile</td><td>6.1 Κατάλογος εκδόχων</td><td>6.1 List of excipients</td><td>6.1 Lista de excipientes</td><td>6.1 Abiainete loetelu</td><td>6.1 Apuaineet</td><td>6.1 Liste des excipients</td><td>6.1 Liosta de na támháin</td><td>6.1 Popis pomoćnih tvari</td><td>6.1 Segédanyagok felsorolása</td><td>6.1 Hjálparefni</td><td>6.1 Elenco degli eccipienti</td><td>6.1 Pagalbinių medžiagų sąrašas</td><td>6.1. Palīgvielu saraksts</td><td>6.1 Lista ta’ eċċipjenti</td><td>6.1 Lijst van hulpstoffen</td><td>6.1 Hjelpestoffer</td><td>6.1 Wykaz substancji pomocniczych</td><td>6.1 Lista dos excipientes</td><td>6.1 Lista excipienților</td><td>6.1 Zoznam pomocných látok</td><td>6.1 Seznam pomožnih snovi</td><td>6.1 Förteckning över hjälpämnen</td></tr><tr><td>200000029838</td><td>6.2 Несъвместимости</td><td>6.2 Inkompatibility</td><td>6.2 Uforligeligheder</td><td>6.2 Inkompatibilitäten</td><td>6.2 Ασυμβατότητες</td><td>6.2 Incompatibilities</td><td>6.2 Incompatibilidades</td><td>6.2 Sobimatus</td><td>6.2 Yhteensopimattomuudet</td><td>6.2 Incompatibilités</td><td>6.2 Neamh-chomhoiriúnachtaí</td><td>6.2 Inkompatibilnosti</td><td>6.2 Inkompatibilitások</td><td>6.2 Ósamrýmanleiki</td><td>6.2 Incompatibilità</td><td>6.2 Nesuderinamumas</td><td>6.2. Nesaderība</td><td>6.2 Inkompatibbiltajiet</td><td>6.2 Gevallen van onverenigbaarheid</td><td>6.2 Uforlikeligheter</td><td>6.2 Niezgodności farmaceutyczne</td><td>6.2 Incompatibilidades</td><td>6.2 Incompatibilități</td><td>6.2 Inkompatibility</td><td>6.2 Inkompatibilnosti</td><td>6.2 Inkompatibiliteter</td></tr><tr><td>200000029839</td><td>6.3 Срок на годност</td><td>6.3 Doba použitelnosti</td><td>6.3 Opbevaringstid</td><td>6.3 Dauer der Haltbarkeit</td><td>6.3 Διάρκεια ζωής</td><td>6.3 Shelf life</td><td>6.3 Periodo de validez</td><td>6.3 Kõlblikkusaeg</td><td>6.3 Kestoaika</td><td>6.3 Durée de conservation</td><td>6.3 Seilfré</td><td>6.3 Rok valjanosti</td><td>6.3 Felhasználhatósági időtartam</td><td>6.3 Geymsluþol</td><td>6.3 Periodo di validità</td><td>6.3 Tinkamumo laikas</td><td>6.3. Uzglabāšanas laiks</td><td>6.3 Żmien kemm idum tajjeb il-prodott mediċinali</td><td>6.3 Houdbaarheid</td><td>6.3 Holdbarhet</td><td>6.3 Okres ważności</td><td>6.3 Prazo de validade</td><td>6.3 Perioada de valabilitate</td><td>6.3 Čas použiteľnosti</td><td>6.3 Rok uporabnosti</td><td>6.3 Hållbarhet</td></tr><tr><td>200000029840</td><td>6.4 Специални условия на съхранение</td><td>6.4 Zvláštní opatření pro uchovávání</td><td>6.4 Særlige opbevaringsforhold</td><td>6.4 Besondere Vorsichtsmaßnahmen für die Aufbewahrung</td><td>6.4 Ιδιαίτερες προφυλάξεις κατά τη φύλαξη του προϊόντος</td><td>6.4 Special precautions for storage</td><td>6.4 Precauciones especiales de conservación</td><td>6.4 Säilitamise eritingimused</td><td>6.4 Säilytys</td><td>6.4 Précautions particulières de conservation</td><td>6.4 Réamhchúraimí stórála ar leith</td><td>6.4 Posebne mjere pri čuvanju lijeka</td><td>6.4 Különleges tárolási előírások</td><td>6.4 Sérstakar varúðarreglur við geymslu</td><td>6.4 Precauzioni particolari per la conservazione</td><td>6.4 Specialios laikymo sąlygos</td><td>6.4. Īpaši uzglabāšanas nosacījumi</td><td>6.4 Prekawzjonijiet speċjali għall-ħażna</td><td>6.4 Speciale voorzorgsmaatregelen bij bewaren</td><td>6.4 Oppbevaringsbetingelser</td><td>6.4 Specjalne środki ostrożności podczas przechowywania</td><td>6.4 Precauções especiais de conservação</td><td>6.4 Precauții speciale pentru păstrare</td><td>6.4 Špeciálne upozornenia na uchovávanie</td><td>6.4 Posebna navodila za shranjevanje</td><td>6.4 Särskilda förvaringsanvisningar</td></tr><tr><td>200000029841</td><td>6.5 Вид и съдържание на опаковката [и специални приспособления за употреба, приложение или имплантиране]</td><td>6.5 Druh obalu a obsah balení [a zvláštní vybavení pro použití, podání nebo implantaci]</td><td>6.5 Emballagetype og pakningsstørrelser [og specielt udstyr til anvendelse, administration eller implantation]</td><td>6.5 Art und Inhalt des Behältnisses [und spezielles Zubehör für den Gebrauch, die Anwendung oder die Implantation]</td><td>6.5 Φύση και συστατικά του περιέκτη [και ειδικός εξοπλισμός για τη χρήση, τη χορήγηση ή την εμφύτευση]</td><td>6.5 Nature and contents of container [and special equipment for use, administration or implantation]</td><td>6.5 Naturaleza y contenido del envase [y de los equipos especiales para su utilización, administración o implantación]</td><td>6.5 Pakendi iseloomustus ja sisu [ja kasutamise, manustamise või implanteerimise erivahendid]</td><td>6.5 Pakkaustyyppi ja pakkauskoko (pakkauskoot) [sekä erityiset välineet lääkkeen käyttöä, antoa tai paikalleen asettamista varten]</td><td>6.5 Nature et contenu de l’emballage extérieur [et équipement spécial pour l’utilisation, l’administration ou la greffe]</td><td>6.5 An cineál coimeádáin agus a bhfuil ann [agus trealamh speisialta lena úsáid, lena thabhairt nó lena ionphlandú]</td><td>6.5 Vrsta i sadržaj spremnika [i posebna oprema za uporabu, primjenu ili ugradnju]</td><td>6.5 Csomagolás típusa és kiszerelése [, valamint speciális eszköz(ök) a használathoz, alkalmazáshoz vagy az implantációhoz]</td><td>6.5 Gerð íláts og innihald[, sérstakur búnaður til notkunar lyfsins, lyfjagjafar eða ísetningar þess]</td><td>6.5 Natura e contenuto del contenitore [e strumentazione particolare per l’uso, la somministrazione o l’impianto]</td><td>6.5 Talpyklės pobūdis ir jos turinys [bei speciali vartojimo ar implantavimo įranga]</td><td>6.5. Iepakojuma veids un saturs [un īpašs aprīkojums lietošanai, ievadīšanai vai implantēšanai]</td><td>6.5 In-natura tal-kontenitur u ta’ dak li hemm ġo fih [u apparat speċjali għall-użu, għall- amministrazzjoni jew għall-impjant]</td><td>6.5 Aard en inhoud van de verpakking [en speciale benodigdheden voor gebruik, toediening of implantatie]</td><td>6.5 Emballasje (type og innhold) [og spesielt utstyr for bruk, administrering eller implantasjon]</td><td>6.5 Rodzaj i zawartość opakowania [oraz specjalistyczny sprzęt, służący do używania, podawania lub implantacji]</td><td>6.5 Natureza e conteúdo do recipiente [e equipamento especial para utilização, administração ou implantação]</td><td>6.5 Natura și conținutul ambalajului [și echipamente speciale pentru utilizare, administrare sau implantare]</td><td>6.5 Druh obalu a obsah balenia [a špeciálne zariadenie na použitie, podanie alebo implantáciu]</td><td>6.5 Vrsta ovojnine in vsebina [ter posebna oprema za uporabo, dajanje ali implantacijo]</td><td>6.5 Förpackningstyp och innehåll [och utrustning för användning, administrering eller implantation]</td></tr><tr><td>200000029842</td><td>6.6 Специални предпазни мерки при изхвърляне [и работа]</td><td>6.6 Zvláštní opatření pro likvidaci přípravku [a pro zacházení s ním]</td><td>6.6 Regler for bortskaffelse [og anden håndtering]</td><td>6.6 Besondere Vorsichtsmaßnahmen für die Beseitigung [und sonstige Hinweise zur Handhabung]</td><td>6.6 Ιδιαίτερες προφυλάξεις απόρριψης [και άλλος χειρισμός]</td><td>6.6 Special precautions for disposal [and other handling]</td><td>6.6 Precauciones especiales de eliminación [y otras manipulaciones]</td><td>6.6 Erihoiatused ravimpreparaadi hävitamiseks [ja käsitlemiseks]</td><td>6.6 Erityiset varotoimet hävittämiselle [ja muut käsittelyohjeet]</td><td>6.6 Précautions particulières d’élimination [et manipulation]</td><td>6.6 Réamhchúraimí ar leith maidir le diúscairt [agus láimhsiú eile]</td><td>6.6 Posebne mjere za zbrinjavanje [i druga rukovanja lijekom]</td><td>6.6 A megsemmisítésre vonatkozó különleges óvintézkedések [és egyéb, a készítmény kezelésével kapcsolatos információk]</td><td>6.6 Sérstakar varúðarráðstafanir við förgun [og önnur meðhöndlun]</td><td>6.6 Precauzioni particolari per lo smaltimento [e la manipolazione]</td><td>6.6 Specialūs reikalavimai atliekoms tvarkyti [ir vaistiniam preparatui ruošti]</td><td>6.6. Īpaši norādījumi atkritumu likvidēšanai [un citi norādījumi par rīkošanos]</td><td>6.6 Prekawzjonijiet speċjali għar-rimi u għal immaniġġar ieħor</td><td>6.6 Speciale voorzorgsmaatregelen voor het verwijderen [en andere instructies]</td><td>6.6 Spesielle forholdsregler for destruksjon [og annen håndtering]</td><td>6.6 Specjalne środki ostrożności dotyczące usuwania [i przygotowania produktu leczniczego do stosowania]</td><td>6.6 Precauções especiais de eliminação [e manuseamento]</td><td>6.6 Precauții speciale pentru eliminarea reziduurilor [și alte instrucțiuni de manipulare]</td><td>6.6 Špeciálne opatrenia na likvidáciu [a iné zaobchádzanie s liekom]</td><td>6.6 Posebni varnostni ukrepi za odstranjevanje [in rokovanje z zdravilom]</td><td>6.6 Särskilda anvisningar för destruktion [och övrig hantering]</td></tr><tr><td>200000029843</td><td>Употреба при педиатричната популация</td><td>Použití u pediatrické populace</td><td>Brug i den pædiatriske population</td><td>Anwendung bei Kindern und Jugendlichen</td><td>Χρήση στον παιδιατρικό πληθυσμό.</td><td>Use in the paediatric population</td><td>Uso en la población pediátrica</td><td>Kasutamine lastel</td><td>Käyttö pediatrisille potilaille</td><td>Utilisation dans la population pédiatrique</td><td>Úsáid sa daonra péidiatrach</td><td>Primjena u pedijatrijskoj populaciji</td><td>Alkalmazása gyermekek és serdülők esetén</td><td>Ef lyfið er notað handa börnum</td><td>Uso nella popolazione pediatrica</td><td>Vartojimas vaikų populiacijai</td><td>Lietošana pediatriskā populācijā</td><td>Użu fil-popolazzjoni pedjatrika</td><td>Gebruik bij pediatrische patiënten</td><td>Bruk i den pediatriske populasjonen</td><td>Stosowanie u dzieci i młodzieży</td><td>Utilização na população pediátrica</td><td>Utilizare la copii și adolescenți</td><td>Použitie v pediatrickej populácii</td><td>Uporaba pri pediatrični populaciji</td><td>Användning i den pediatriska populationen</td></tr><tr><td>200000029844</td><td>7. ПРИТЕЖАТЕЛ НА РАЗРЕШЕНИЕТО ЗА УПОТРЕБА</td><td>7. DRŽITEL ROZHODNUTÍ O REGISTRACI</td><td>7. INDEHAVER AF MARKEDSFØRINGSTILLADELSEN</td><td>7. INHABER DER ZULASSUNG</td><td>7. ΚΑΤΟΧΟΣ ΤΗΣ ΑΔΕΙΑΣ ΚΥΚΛΟΦΟΡΙΑΣ</td><td>7. MARKETING AUTHORISATION HOLDER</td><td>7. TITULAR DE LA AUTORIZACIÓN DE COMERCIALIZACIÓN</td><td>7. MÜÜGILOA HOIDJA</td><td>7. MYYNTILUVAN HALTIJA</td><td>7. TITULAIRE DE L’AUTORISATION DE MISE SUR LE MARCHÉ</td><td>7. SEALBHÓIR AN ÚDARAITHE MARGAÍOCHTA</td><td>7. NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET</td><td>7. A FORGALOMBA HOZATALI ENGEDÉLY JOGOSULTJA</td><td>7. MARKAÐSLEYFISHAFI</td><td>7. TITOLARE DELL’AUTORIZZAZIONE ALL’IMMISSIONE IN COMMERCIO</td><td>7. REGISTRUOTOJAS</td><td>7. REĢISTRĀCIJAS APLIECĪBAS ĪPAŠNIEKS</td><td>7. DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ</td><td>7. HOUDER VAN DE VERGUNNING VOOR HET IN DE HANDEL BRENGEN</td><td>7. INNEHAVER AV MARKEDSFØRINGSTILLATELSEN</td><td>7. PODMIOT ODPOWIEDZIALNY POSIADAJĄCY POZWOLENIE NA DOPUSZCZENIE DO OBROTU</td><td>7. TITULAR DA AUTORIZAÇÃO DE INTRODUÇÃO NO MERCADO</td><td>7. DEȚINĂTORUL AUTORIZAȚIEI DE PUNERE PE PIAȚĂ</td><td>7. DRŽITEĽ ROZHODNUTIA O REGISTRÁCII</td><td>7. IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM</td><td>7. INNEHAVARE AV GODKÄNNANDE FÖR FÖRSÄLJNING</td></tr><tr><td>200000029845</td><td>8. НОМЕР(А) НА РАЗРЕШЕНИЕТО ЗА УПОТРЕБА</td><td>8. REGISTRAČNÍ ČÍSLO/REGISTRAČNÍ ČÍSLA</td><td>8. MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE)</td><td>8. ZULASSUNGSNUMMER(N)</td><td>8. ΑΡΙΘΜΟΣ(ΟΙ) ΑΔΕΙΑΣ ΚΥΚΛΟΦΟΡΙΑΣ</td><td>8. MARKETING AUTHORISATION NUMBER(S)</td><td>8. NÚMERO(S) DE AUTORIZACIÓN DE COMERCIALIZACIÓN</td><td>8. MÜÜGILOA NUMBER (NUMBRID)</td><td>8. MYYNTILUVAN NUMERO(T)</td><td>8. NUMÉRO(S) D’AUTORISATION DE MISE SUR LE MARCHÉ</td><td>8. UIMHIR/UIMHREACHA AN ÚDARAITHE MARGAÍOCHTA</td><td>8. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET</td><td>8. A FORGALOMBA HOZATALI ENGEDÉLY SZÁMA(I)</td><td>8. MARKAÐSLEYFISNÚMER</td><td>8. NUMERO(I) DELL’AUTORIZZAZIONE ALL’IMMISSIONE IN COMMERCIO</td><td>8. REGISTRACIJOS PAŽYMĖJIMO NUMERIS (-IAI)</td><td>8. REĢISTRĀCIJAS APLIECĪBAS NUMURS(-I)</td><td>8. NUMRU(I) TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ</td><td>8. NUMMER(S) VAN DE VERGUNNING VOOR HET IN DE HANDEL BRENGEN</td><td>8. MARKEDSFØRINGSTILLATELSESNUMMER (NUMRE)</td><td>8. [NUMER POZWOLENIA] [NUMERY POZWOLEŃ] NA DOPUSZCZENIE DO OBROTU</td><td>8. NÚMERO(S) DA AUTORIZAÇÃO DE INTRODUÇÃO NO MERCADO</td><td>8. NUMĂRUL(ELE) AUTORIZAȚIEI DE PUNERE PE PIAȚĂ</td><td>8. REGISTRAČNÉ [ČÍSLO] [ČÍSLA]</td><td>8. ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM</td><td>8. NUMMER PÅ GODKÄNNANDE FÖR FÖRSÄLJNING</td></tr><tr><td>200000029846</td><td>9. ДАТА НА ПЪРВО РАЗРЕШАВАНЕ/ПОДНОВЯВАНЕ НА РАЗРЕШЕНИЕТО ЗА УПОТРЕБА</td><td>9. DATUM PRVNÍ REGISTRACE/PRODLOUŽENÍ REGISTRACE</td><td>9. DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN</td><td>9. DATUM DER ERTEILUNG DER ZULASSUNG/VERLÄNGERUNG DER ZULASSUNG</td><td>9. ΗΜΕΡΟΜΗΝΙΑ ΠΡΩΤΗΣ ΕΓΚΡΙΣΗΣ/ΑΝΑΝΕΩΣΗΣ ΤΗΣ ΑΔΕΙΑΣ</td><td>9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION</td><td>9. FECHA DE LA PRIMERA AUTORIZACIÓN/RENOVACIÓN DE LA AUTORIZACIÓN</td><td>9. ESMASE MÜÜGILOA VÄLJASTAMISE/MÜÜGILOA UUENDAMISE KUUPÄEV</td><td>9. MYYNTILUVAN MYÖNTÄMISPÄIVÄMÄÄRÄ/UUDISTAMISPÄIVÄMÄÄRÄ</td><td>9. DATE DE PREMIÈRE AUTORISATION/DE RENOUVELLEMENT DE L’AUTORISATION</td><td>9. DÁTA AN CHÉAD ÚDARAITHE/ATHNUACHAN AN ÚDARAITHE</td><td>9. DATUM PRVOG ODOBRENJA / DATUM OBNOVE ODOBRENJA</td><td>9. A FORGALOMBA HOZATALI ENGEDÉLY ELSŐ KIADÁSÁNAK/ MEGÚJÍTÁSÁNAK DÁTUMA</td><td>9. DAGSETNING FYRSTU ÚTGÁFU MARKAÐSLEYFIS / ENDURNÝJUNAR MARKAÐSLEYFIS</td><td>9. DATA DELLA PRIMA AUTORIZZAZIONE/RINNOVO DELL’AUTORIZZAZIONE</td><td>9. REGISTRAVIMO / PERREGISTRAVIMO DATA</td><td>9. PIRMĀS REĢISTRĀCIJAS/PĀRREĢISTRĀCIJAS DATUMS</td><td>9. DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI</td><td>9. DATUM VAN EERSTE VERLENING VAN DE VERGUNNING/VERLENGING VAN DE VERGUNNING</td><td>9. DATO FOR FØRSTE MARKEDSFØRINGSTILLATELSE / SISTE FORNYELSE</td><td>9. DATA WYDANIA PIERWSZEGO POZWOLENIA NA DOPUSZCZENIE DO OBROTU I DATA PRZEDŁUŻENIA POZWOLENIA</td><td>9. DATA DA PRIMEIRA AUTORIZAÇÃO/RENOVAÇÃO DA AUTORIZAÇÃO DE INTRODUÇÃO NO MERCADO</td><td>9. DATA PRIMEI AUTORIZĂRI SAU A REÎNNOIRII AUTORIZAȚIEI</td><td>9. DÁTUM PRVEJ REGISTRÁCIE/PREDĹŽENIA REGISTRÁCIE</td><td>9. DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM</td><td>9. DATUM FÖR FÖRSTA GODKÄNNANDE/FÖRNYAT GODKÄNNANDE</td></tr><tr><td>200000029847</td><td>10. ДАТА НА АКТУАЛИЗИРАНЕ НА ТЕКСТА</td><td>10. DATUM REVIZE TEXTU</td><td>10. DATO FOR ÆNDRING AF TEKSTEN</td><td>10. STAND DER INFORMATION</td><td>10. ΗΜΕΡΟΜΗΝΙΑ ΑΝΑΘΕΩΡΗΣΗΣ ΤΟΥ ΚΕΙΜΕΝΟΥ</td><td>10. DATE OF REVISION OF THE TEXT</td><td>10. FECHA DE LA REVISIÓN DEL TEXTO</td><td>10. TEKSTI LÄBIVAATAMISE KUUPÄEV</td><td>10. TEKSTIN MUUTTAMISPÄIVÄMÄÄRÄ</td><td>10. DATE DE MISE À JOUR DU TEXTE</td><td>10. DÁTA ATHBHREITHNITHE AN TÉACS</td><td>10. DATUM REVIZIJE TEKSTA</td><td>10. A SZÖVEG ELLENŐRZÉSÉNEK DÁTUMA</td><td>10. DAGSETNING ENDURSKOÐUNAR TEXTANS</td><td>10. DATA DI REVISIONE DEL TESTO</td><td>10. TEKSTO PERŽIŪROS DATA</td><td>10. TEKSTA PĀRSKATĪŠANAS DATUMS</td><td>10. DATA TA’ REVIŻJONI TAT-TEST</td><td>10. DATUM VAN HERZIENING VAN DE TEKST</td><td>10. OPPDATERINGSDATO</td><td>10. DATA ZATWIERDZENIA LUB CZĘŚCIOWEJ ZMIANY TEKSTU CHARAKTERYSTYKI PRODUKTU LECZNICZEGO</td><td>10. DATA DA REVISÃO DO TEXTO</td><td>10. DATA REVIZUIRII TEXTULUI</td><td>10. DÁTUM REVÍZIE TEXTU</td><td>10. DATUM ZADNJE REVIZIJE BESEDILA</td><td>10. DATUM FÖR ÖVERSYN AV PRODUKTRESUMÉN</td></tr><tr><td>200000029848</td><td>11. ДОЗИМЕТРИЯ</td><td>11. DOZIMETRIE</td><td>11. DOSIMETRI</td><td>11. DOSIMETRIE</td><td>11. ΔΟΣΙΜΕΤΡΙΑ</td><td>11. DOSIMETRY</td><td>11. DOSIMETRÍA</td><td>11. DOSIMEETRIA</td><td>11. DOSIMETRIA</td><td>11. DOSIMÉTRIE</td><td>11. DÁILEOGMHÉADRACHT</td><td>11. DOZIMETRIJA</td><td>11. VÁRHATÓ SUGÁRTERHELÉS</td><td>11. GEISLUNARMÆLINGAR</td><td>11. DOSIMETRIA</td><td>11. DOZIMETRIJA</td><td>11. DOZIMETRIJA</td><td>11. DOŻIMETRIJA</td><td>11. DOSIMETRIE</td><td>11. DOSIMETRI</td><td>11. DOZYMETRIA</td><td>11. DOSIMETRIA</td><td>11. DOZIMETRIE</td><td>11. DOZIMETRIA</td><td>11. DOZIMETRIJA</td><td>11. ABSORBERAD DOS OCH EFFEKTIV DOS</td></tr><tr><td>200000029849</td><td>12. ИНСТРУКЦИИ ЗА ПРИГОТВЯНЕ НА РАДИОФАРМАЦЕВТИЦИ</td><td>12. NÁVOD PRO PŘÍPRAVU RADIOFARMAK</td><td>12. INSTRUKTIONER FOR FREMSTILLING AF RADIOAKTIVE LÆGEMIDLER</td><td>12. ANWEISUNGEN ZUR ZUBEREITUNG VON RADIOAKTIVEN ARZNEIMITTELN</td><td>12. ΟΔΗΓΙΕΣ ΠΑΡΑΣΚΕΥΗΣ ΡΑΔΙΟΦΑΡΜΑΚΩΝ</td><td>12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS</td><td>12. INSTRUCCIONES PARA LA PREPARACIÓN DE RADIOFÁRMACOS</td><td>12. RADIOFARMATSEUTILISE PREPARAADI VALMISTAMISE JUHEND</td><td>12. RADIOFARMASEUTTISTEN VALMISTEIDEN VALMISTUSOHJEET</td><td>12. INSTRUCTIONS POUR LA PRÉPARATION DES RADIOPHARMACEUTIQUES</td><td>12. TREORACHA CHUN RADACHÓGAIS A ULLMHÚ</td><td>12. UPUTE ZA PRIPREMU RADIOFARMACEUTIKA</td><td>12. RADIOAKTÍV GYÓGYSZEREK ELKÉSZÍTÉSÉRE VONATKOZÓ ÚTMUTATÁSOK</td><td>12. LEIÐBEININGAR UM BLÖNDUN GEISLAVIRKRA LYFJA</td><td>12. ISTRUZIONI PER LA PREPARAZIONE DI RADIOFARMACI</td><td>12. RADIOFARMACINIŲ PREPARATŲ RUOŠIMO INSTRUKCIJA</td><td>12. NORĀDĪJUMI PAR RADIOFARMACEITISKO ZĀĻU SAGATAVOŠANU</td><td>12. ISTRUZZJONIJIET GĦALL-PREPARAZZJONI TA’ PRODOTTI RADJUFARMAĊEWTIĊI</td><td>12. INSTRUCTIES VOOR DE BEREIDING VAN RADIOACTIEVE GENEESMIDDELEN</td><td>12. INSTRUKSJONER FOR TILBEREDELSE AV RADIOFARMAKA</td><td>12. INSTRUKCJA PRZYGOTOWANIA PRODUKTÓW RADIOFARMACEUTYCZNYCH</td><td>12. INSTRUÇÕES PARA A PREPARAÇÃO DE RADIOFÁRMACOS</td><td>12. INSTRUCȚIUNI PRIVIND PREPARAREA MEDICAMENTELOR RADIOFARMACEUTICE</td><td>12. POKYNY NA PRÍPRAVU RÁDIOFARMÁK</td><td>12. NAVODILA ZA PRIPRAVO RADIOFARMAKOV</td><td>12. INSTRUKTION FÖR BEREDNING AV RADIOFARMAKA</td></tr><tr><td>200000029850</td><td>ПРИЛОЖЕНИЕ II</td><td>PŘÍLOHA II</td><td>BILAG II</td><td>ANHANG II</td><td>ΠΑΡΑΡΤΗΜΑ ΙΙ</td><td>ANNEX II</td><td>ANEXO II</td><td>II LISA</td><td>LIITE II</td><td>ANNEXE II</td><td>IARSCRÍBHINN II</td><td>PRILOG II.</td><td>II. MELLÉKLET</td><td>VIÐAUKI II</td><td>ALLEGATO II</td><td>II PRIEDAS</td><td>II PIELIKUMS</td><td>ANNESS II</td><td>BIJLAGE II</td><td>VEDLEGG II</td><td>ANEKS II</td><td>ANEXO II</td><td>ANEXA II</td><td>PRÍLOHA II</td><td>PRILOGA II</td><td>BILAGA II</td></tr><tr><td>200000029851</td><td>A. [ПРОИЗВОДИТЕЛ(И) НА БИОЛОГИЧНО АКТИВНОТО(ИТЕ) ВЕЩЕСТВО(А) И]ПРОИЗВОДИТЕЛ(И), ОТГОВОРЕН(НИ) ЗА ОСВОБОЖДАВАНЕ НА ПАРТИДИ</td><td>A. [VÝROBCE/VÝROBCI BIOLOGICKÉ LÉČIVÉ LÁTKY/BIOLOGICKÝCH LÉČIVÝCH LÁTEK A] VÝROBCE ODPOVĚDNÝ/VÝROBCI ODPOVĚDNÍ ZA PROPOUŠTĚNÍ ŠARŽÍ</td><td>A. [FREMSTILLER(E) AF DET (DE) BIOLOGISK AKTIVE STOF(FER) OG] FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE</td><td>A. [HERSTELLER DES WIRKSTOFFS/DER WIRKSTOFFE BIOLOGISCHEN URSPRUNGS UND] HERSTELLER, DER (DIE) FÜR DIE CHARGENFREIGABE VERANTWORTLICH IST (SIND)</td><td>Α. [ ΠΑΡΑΣΚΕΥΑΣΤΗΣ(ΕΣ) ΤΗΣ(ΤΩΝ) ΒΙΟΛΟΓΙΚΩΣ ΔΡΑΣΤΙΚΗΣ(ΩΝ) ΟΥΣΙΑΣ(ΩΝ) ΚΑΙ] ΠΑΡΑΣΚΕΥΑΣΤΗΣ(ΕΣ) ΥΠΕΥΘΥΝΟΣ(ΟΙ) ΓΙΑ ΤΗΝ ΑΠΟΔΕΣΜΕΥΣΗ ΤΩΝ ΠΑΡΤΙΔΩΝ</td><td>A. [MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND] MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE</td><td>A. [FABRICANTE(S) DEL (DE LOS) PRINCIPIO(S) ACTIVO(S) BIOLÓGICO(S) Y] FABRICANTE(S) RESPONSABLE(S) DE LA LIBERACIÓN DE LOS LOTES</td><td>A. [BIOLOOGILIS(T)E TOIMEAINE(TE) TOOTJA(D) JA] RAVIMIPARTII KASUTAMISEKS VABASTAMISE EEST VASTUTAV(AD) TOOTJA(D)</td><td>A. [BIOLOGISEN (BIOLOGISTEN) VAIKUTTAVAN (VAIKUTTAVIEN) AINEEN (AINEIDEN) VALMISTAJA (VALMISTAJAT) JA] ERÄN VAPAUTTAMISESTA VASTAAVA(T) VALMISTAJA(T)</td><td>A. [FABRICANT(S) DE LA/DES SUBSTANCE(S) ACTIVE(S) D’ORIGINE BIOLOGIQUE ET ] FABRICANT(S) RESPONSABLE(S) DE LA LIBÉRATION DES LOTS</td><td>A. [MONARÓIR(Í) NA SUBSTAINTE GNÍOMHAÍ BITHEOLAÍCHE/NA SUBSTAINTÍ GNÍOMHACHA BITHEOLAÍOCHA AGUS] MONARÓIR(Í) ATÁ FREAGRACH AS BAISCEANNA A SCAOILEADH</td><td>A. [PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I] PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET</td><td>A. [A BIOLÓGIAI EREDETŰ HATÓANYAG(OK) GYÁRTÓJA/GYÁRTÓI ÉS]A GYÁRTÁSI TÉTELEK VÉGFELSZABADÍTÁSÁÉRT FELELŐS GYÁRTÓ(K)</td><td>A. [FRAMLEIÐENDUR LÍFFRÆÐILEGRA VIRKRA EFNA OG ]FRAMLEIÐENDUR SEM ERU ÁBYRGIR FYRIR LOKASAMÞYKKT</td><td>A. [PRODUTTORE(I) DEL(DEI) PRINCIPIO(I) ATTIVO(I) BIOLOGICO(I) E] PRODUTTORE(I) RESPONSABILE(I) DEL RILASCIO DEI LOTTI</td><td>A. [BIOLOGINĖS (-IŲ) VEIKLIOSIOS (-IŲJŲ) MEDŽIAGOS (-Ų) GAMINTOJAS (-AI) IR] GAMINTOJAS (-AI), ATSAKINGAS (-I) UŽ SERIJŲ IŠLEIDIMĄ</td><td>A. [BIOLOĢISKI AKTĪVĀS(-O) VIELAS (-U) RAŽOTĀJS(-I) UN] RAŽOTĀJS(-I), KAS ATBILD PAR SĒRIJAS IZLAIDI</td><td>A. [MANIFATTUR(I) TAS-SUSTANZA/I) BIJOLOĠIKA(ĊI ATTIVA/I U] MANIFATTUR(I) RESPONSABBLI GĦALL-ĦRUĠ TAL-LOTT</td><td>A. [FABRIKANT(EN) VAN DE BIOLOGISCH WERKZAME STOF(FEN) EN ]FABRIKANT(EN) VERANTWOORDELIJK VOOR VRIJGIFTE</td><td>A. [TILVIRKER(E) AV BIOLOGISK (E) VIRKESTOFF(ER) OG] TILVIRKER(E) ANSVARLIG FOR BATCH RELEASE</td><td>A. [WYTWÓRCA] [WYTWÓRCY] [BIOLOGICZNEJ SUBSTANCJI CZYNNEJ] [BIOLOGICZNYCH SUBSTANCJI CZYNNYCH] ORAZ] [WYTWÓRCA ODPOWIEDZIALNY] [WYTWÓRCY ODPOWIEDZIALNI] ZA ZWOLNIENIE SERII</td><td>A. [FABRICANTE(S) DA(S) SUBSTÂNCIA(S) ATIVA(S) DE ORIGEM BIOLÓGICA E]FABRICANTE(S) RESPONSÁVEL(VEIS) PELA LIBERTAÇÃO DO LOTE</td><td>A. [FABRICANTUL(FABRICANȚII) SUBSTANȚEI(LOR) BIOLOGIC ACTIVE ȘI] FABRICANTUL (FABRICANȚII) RESPONSABIL(I) PENTRU ELIBERAREA SERIEI</td><td>A. [VÝROBCA (VÝROBCOVIA) BIOLOGICKÉHO LIEČIVA (BIOLOGICKÝCH LIEČIV) A]VÝROBCA (VÝROBCOVIA) ZODPOVEDNÝ (ZODPOVEDNÍ) ZA UVOĽNENIE ŠARŽE</td><td>A. [PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN] PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ</td><td>A. [ TILLVERKARE AV DEN (DE) AKTIVA SUBSTANSEN (SUBSTANSERNA) AV BIOLOGISKT URSPRUNG OCH ] TILLVERKARE SOM ANSVARAR FÖR FRISLÄPPANDE AV TILLVERKNINGSSATS</td></tr><tr><td>200000029852</td><td>Б. УСЛОВИЯ ИЛИ ОГРАНИЧЕНИЯ ЗА ДОСТАВКА И УПОТРЕБА</td><td>B. PODMÍNKY NEBO OMEZENÍ VÝDEJE A POUŽITÍ</td><td>B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE</td><td>B. BEDINGUNGEN ODER EINSCHRÄNKUNGEN FÜR DIE ABGABE UND DEN GEBRAUCH</td><td>Β. ΟΡΟΙ Ή ΠΕΡΙΟΡΙΣΜΟΙ ΣΧΕΤΙΚΑ ΜΕ ΤΗ ΔΙΑΘΕΣΗ ΚΑΙ ΤΗ ΧΡΗΣΗ</td><td>B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE</td><td>B. CONDICIONES O RESTRICCIONES DE SUMINISTRO Y USO</td><td>B. HANKE- JA KASUTUSTINGIMUSED VÕI PIIRANGUD</td><td>B. TOIMITTAMISEEN JA KÄYTTÖÖN LIITTYVÄT EHDOT TAI RAJOITUKSET</td><td>B. CONDITIONS OU RESTRICTIONS DE DÉLIVRANCE ET D’UTILISATION</td><td>B. COINNÍOLLACHA NÓ SRIANTA MAIDIR LE SOLÁTHAR AGUS ÚSÁID</td><td>B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU</td><td>B. A KIADÁSRA ÉS A FELHASZNÁLÁSRA VONATKOZÓ FELTÉTELEK VAGY KORLÁTOZÁSOK</td><td>B. FORSENDUR FYRIR, EÐA TAKMARKANIR Á, AFGREIÐSLU OG NOTKUN</td><td>B. CONDIZIONI O LIMITAZIONI DI FORNITURA E UTILIZZO</td><td>B. TIEKIMO IR VARTOJIMO SĄLYGOS AR APRIBOJIMAI</td><td>B. IZSNIEGŠANAS KĀRTĪBAS UN LIETOŠANAS NOSACĪJUMI VAI IEROBEŽOJUMI</td><td>B. KONDIZZJONIJIET JEW RESTRIZZJONIJIET RIGWARD IL-PROVVISTA U L-UŻU</td><td>B. VOORWAARDEN OF BEPERKINGEN TEN AANZIEN VAN LEVERING EN GEBRUIK</td><td>B. VILKÅR ELLER RESTRIKSJONER VEDRØRENDE LEVERANSE OG BRUK</td><td>B. WARUNKI LUB OGRANICZENIA DOTYCZĄCE ZAOPATRZENIA I STOSOWANIA</td><td>B. CONDIÇÕES OU RESTRIÇÕES RELATIVAS AO FORNECIMENTO E UTILIZAÇÃO</td><td>B. CONDIȚII SAU RESTRICȚII PRIVIND FURNIZAREA ȘI UTILIZAREA</td><td>B. PODMIENKY ALEBO OBMEDZENIA TÝKAJÚCE SA VÝDAJA A POUŽITIA</td><td>B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE</td><td>B. VILLKOR ELLER BEGRÄNSNINGAR FÖR TILLHANDAHÅLLANDE OCH ANVÄNDNING</td></tr><tr><td>200000029853</td><td>Официално освобождаване на партиди</td><td>Úřední propouštění šarží</td><td>Officiel batchfrigivelse</td><td>Amtliche Chargenfreigabe</td><td>Επίσημη αποδέσμευση παρτίδων</td><td>Official batch release</td><td>Liberación oficial de los lotes</td><td>Ravimipartii ametlik kasutamiseks vabastamine</td><td>Erän virallinen vapauttaminen</td><td>Libération officielle des lots</td><td>Scaoileadh baisce oifigiúil</td><td>Službeno puštanje serije lijeka u promet</td><td>Gyártási tételek hivatalos végfelszabadítása</td><td>Opinber lokasamþykkt</td><td>Rilascio ufficiale dei lotti</td><td>Oficialus serijų išleidimas</td><td>Oficiāla sērijas izlaide</td><td>Ħruġ tal-lott uffiċjali</td><td>Officiële vrijgifte van de batch</td><td>Offisiell batch release</td><td>Oficjalne zwalnianie serii</td><td>Libertação oficial do lote</td><td>Eliberarea oficială a seriei</td><td>Oficiálne uvoľnenie šarže</td><td>Uradna sprostitev serije:</td><td>Officiellt frisläppande av tillverkningssats</td></tr><tr><td>200000029854</td><td>В. ДРУГИ УСЛОВИЯ И ИЗИСКВАНИЯ НА РАЗРЕШЕНИЕТО ЗА УПОТРЕБА</td><td>C. DALŠÍ PODMÍNKY A POŽADAVKY REGISTRACE</td><td>C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN</td><td>C. SONSTIGE BEDINGUNGEN UND AUFLAGEN DER GENEHMIGUNG FÜR DAS INVERKEHRBRINGEN]</td><td>Γ. ΑΛΛΟΙ ΟΡΟΙ ΚΑΙ ΑΠΑΙΤΗΣΕΙΣ ΤΗΣ ΑΔΕΙΑΣ ΚΥΚΛΟΦΟΡΙΑΣ</td><td>C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION</td><td>C. OTRAS CONDICIONES Y REQUISITOS DE LA AUTORIZACIÓN DE COMERCIALIZACIÓN</td><td>C. MÜÜGILOA MUUD TINGIMUSED JA NÕUDED</td><td>C. MYYNTILUVAN MUUT EHDOT JA EDELLYTYKSET</td><td>C. AUTRES CONDITIONS ET OBLIGATIONS DE L’AUTORISATION DE MISE SUR LE MARCHÉ</td><td>C. COINNÍOLLACHA AGUS CEANGLAIS EILE DE CHUID AN ÚDARAITHE MARGAÍOCHTA</td><td>C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET</td><td>C. A FORGALOMBA HOZATALI ENGEDÉLYBEN FOGLALT EGYÉB FELTÉTELEK ÉS KÖVETELMÉNYEK</td><td>C. AÐRAR FORSENDUR OG SKILYRÐI MARKAÐSLEYFIS</td><td>C. ALTRE CONDIZIONI E REQUISITI DELL’AUTORIZZAZIONE ALL’IMMISSIONE IN COMMERCIO</td><td>C. KITOS SĄLYGOS IR REIKALAVIMAI REGISTRUOTOJUI</td><td>C. CITI REĢISTRĀCIJAS NOSACĪJUMI UN PRASĪBAS</td><td>C. KONDIZZJONIJIET U REKWIŻITI OĦRA TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ</td><td>C. ANDERE VOORWAARDEN EN EISEN DIE DOOR DE HOUDER VAN DE HANDELSVERGUNNING MOETEN WORDEN NAGEKOMEN</td><td>C. ANDRE VILKÅR OG KRAV TIL MARKEDSFØRINGSTILLATELSEN</td><td>C. INNE WARUNKI I WYMAGANIA DOTYCZĄCE DOPUSZCZENIA DO OBROTU</td><td>C. OUTRAS CONDIÇÕES E REQUISITOS DA AUTORIZAÇÃO DE INTRODUÇÃO NO MERCADO</td><td>C. ALTE CONDIȚII ȘI CERINȚE ALE AUTORIZAȚIEI DE PUNERE PE PIAȚĂ</td><td>C. ĎALŠIE PODMIENKY A POŽIADAVKY REGISTRÁCIE</td><td>C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM</td><td>C. ÖVRIGA VILLKOR OCH KRAV FÖR GODKÄNNANDET FÖR FÖRSÄLJNING</td></tr><tr><td>200000029855</td><td>Периодични актуализирани доклади за безопасност (ПАДБ)</td><td>Pravidelně aktualizované zprávy o bezpečnosti (PSUR)</td><td>Periodiske, opdaterede sikkerhedsindberetninger (PSUR’er)</td><td>Regelmäßig aktualisierte Unbedenklichkeitsberichte [Periodic Safety Update Reports (PSURs)]</td><td>Εκθέσεις περιοδικής παρακολούθησης της ασφάλειας (PSURs)</td><td>Periodic safety update reports (PSURs)</td><td>Informes periódicos de seguridad (IPSs)</td><td>Perioodilised ohutusaruanded</td><td>Määräaikaiset turvallisuuskatsaukset</td><td>Rapports périodiques actualisés de sécurité (PSURs)</td><td>Tuarascálacha tréimhsiúla chun dáta maidir le sábháilteacht (PSURanna)</td><td>Periodička izvješća o neškodljivosti lijeka (PSUR-evi)</td><td>Időszakos gyógyszerbiztonsági jelentések (Periodic safety update report, PSUR)</td><td>Samantektir um öryggi lyfsins (PSUR)</td><td>Rapporti periodici di aggiornamento sulla sicurezza (PSUR)</td><td>Periodiškai atnaujinami saugumo protokolai (PASP)</td><td>Periodiski atjaunojamais drošuma ziņojums (PSUR)</td><td>Rapporti perjodiċi aġġornati dwar is-sigurtà (PSURs)</td><td>Periodieke veiligheidsverslagen</td><td>Periodiske sikkerhetsoppdateringsrapporter (PSUR-er)</td><td>Okresowe raporty o bezpieczeństwie stosowania (ang. Periodic safety update reports, PSURs)</td><td>Relatórios periódicos de segurança (RPS)</td><td>Rapoartele periodice actualizate privind siguranța (RPAS)</td><td>Periodicky aktualizované správy o bezpečnosti (Periodic safety update reports, PSUR)</td><td>Redno posodobljena poročila o varnosti zdravila (PSUR)</td><td>Periodiska säkerhetsrapporter</td></tr><tr><td>200000029856</td><td>Г. УСЛОВИЯ ИЛИ ОГРАНИЧЕНИЯ ЗА БЕЗОПАСНА И ЕФЕКТИВНА УПОТРЕБА НА ЛЕКАРСТВЕНИЯ ПРОДУКТ</td><td>D. PODMÍNKY NEBO OMEZENÍ S OHLEDEM NA BEZPEČNÉ A ÚČINNÉ POUŽÍVÁNÍ LÉČIVÉHO PŘÍPRAVKU</td><td>D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET</td><td>D. BEDINGUNGEN ODER EINSCHRÄNKUNGEN FÜR DIE SICHERE UND WIRKSAME ANWENDUNG DES ARZNEIMITTELS</td><td>Δ. ΟΡΟΙ Ή ΠΕΡΙΟΡΙΣΜΟΙ ΣΧΕΤΙΚΑ ΜΕ ΤΗΝ ΑΣΦΑΛΗ ΚΑΙ ΑΠΟΤΕΛΕΣΜΑΤΙΚΗ ΧΡΗΣΗ ΤΟΥ ΦΑΡΜΑΚΕΥΤΙΚΟΥ ΠΡΟΪΟΝΤΟΣ</td><td>D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT</td><td>D. CONDICIONES O RESTRICCIONES EN RELACIÓN CON LA UTILIZACIÓN SEGURA Y EFICAZ DEL MEDICAMENTO</td><td>D. RAVIMPREPARAADI OHUTU JA EFEKTIIVSE KASUTAMISE TINGIMUSED JA PIIRANGUD</td><td>D. EHDOT TAI RAJOITUKSET, JOTKA KOSKEVAT LÄÄKEVALMISTEEN TURVALLISTA JA TEHOKASTA KÄYTTÖÄ</td><td>D. CONDITIONS OU RESTRICTIONS EN VUE D’UNE UTILISATION SÛRE ET EFFICACE DU MÉDICAMENT</td><td>D. COINNÍOLLACHA NÓ SRIANTA MAIDIR LE hÚSÁID SHÁBHÁILTE ÉIFEACHTACH AN TÁIRGE ÍOCSHLÁINTE</td><td>D. UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA</td><td>D. A GYÓGYSZER BIZTONSÁGOS ÉS HATÉKONY ALKALMAZÁSÁRA VONATKOZÓ FELTÉTELEK VAGY KORLÁTOZÁSOK</td><td>D. FORSENDUR EÐA TAKMARKANIR ER VARÐA ÖRYGGI OG VERKUN VIÐ NOTKUN LYFSINS</td><td>D. CONDIZIONI O LIMITAZIONI PER QUANTO RIGUARDA L’USO SICURO ED EFFICACE DEL MEDICINALE</td><td>D. SĄLYGOS AR APRIBOJIMAI, SKIRTI SAUGIAM IR VEIKSMINGAM VAISTINIO PREPARATO VARTOJIMUI UŽTIKRINTI</td><td>D. NOSACĪJUMI VAI IEROBEŽOJUMI ATTIECĪBĀ UZ DROŠU UN EFEKTĪVU ZĀĻU LIETOŠANU</td><td>D. KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TAL-UŻU SIGUR U EFFIKAĊI TAL-PRODOTT MEDIĊINALI</td><td>D. VOORWAARDEN OF BEPERKINGEN MET BETREKKING TOT EEN VEILIG EN DOELTREFFEND GEBRUIK VAN HET GENEESMIDDEL</td><td>D. VILKÅR ELLER RESTRIKSJONER VEDRØRENDE SIKKER OG EFFEKTIV BRUK AV LEGEMIDLET</td><td>D. WARUNKI LUB OGRANICZENIA DOTYCZĄCE BEZPIECZNEGO I SKUTECZNEGO STOSOWANIA PRODUKTU LECZNICZEGO</td><td>D. CONDIÇÕES OU RESTRIÇÕES RELATIVAS À UTILIZAÇÃO SEGURA E EFICAZ DO MEDICAMENTO</td><td>D. CONDIȚII SAU RESTRICȚII CU PRIVIRE LA UTILIZAREA SIGURĂ ȘI EFICACE A MEDICAMENTULUI</td><td>D. PODMIENKY ALEBO OBMEDZENIA TÝKAJÚCE SA BEZPEČNÉHO A ÚČINNÉHO POUŽÍVANIA LIEKU</td><td>D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA</td><td>D. VILLKOR ELLER BEGRÄNSNINGAR AVSEENDE EN SÄKER OCH EFFEKTIV ANVÄNDNING AV LÄKEMEDLET</td></tr><tr><td>200000029857</td><td>План за управление на риска (ПУР)</td><td>Plán řízení rizik (RMP)</td><td>Risikostyringsplan (RMP)</td><td>Risikomanagement-Plan (RMP)</td><td>Σχέδιο διαχείρισης κινδύνου (ΣΔΚ)</td><td>Risk management plan (RMP)</td><td>Plan de gestión de riesgos (PGR)</td><td>Riskijuhtimiskava</td><td>Riskienhallintasuunnitelma (RMP)</td><td>Plan de gestion des risques (PGR)</td><td>Plean bainistithe riosca (PBR)</td><td>Plan upravljanja rizikom (RMP)</td><td>Kockázatkezelési terv</td><td>Áætlun um áhættustjórnun</td><td>Piano di gestione del rischio (RMP)</td><td>Rizikos valdymo planas (RVP)</td><td>Riska pārvaldības plāns (RPP)</td><td>Pjan tal-ġestjoni tar-riskju (RMP)</td><td>Risk Management Plan (RMP)</td><td>Risikohåndteringsplan (RMP)</td><td>Plan zarządzania ryzykiem (ang. Risk Management Plan, RMP)</td><td>Plano de gestão do risco (PGR)</td><td>Planul de management al riscului (PMR)</td><td>Plán riadenia rizík (RMP)</td><td>Načrt za obvladovanje tveganj (RMP)</td><td>Riskhanteringsplan</td></tr><tr><td>200000029858</td><td>Допълнителни мерки за свеждане на риска до минимум</td><td>Další opatření k minimalizaci rizik</td><td>Yderligere risikominimeringsforanstaltninger</td><td>Zusätzliche Maßnahmen zur Risikominimierung</td><td>Επιπρόσθετα μέτρα ελαχιστοποίησης κινδύνου</td><td>Additional risk minimisation measures</td><td>Medidas adicionales de minimización de riesgos</td><td>Riski minimeerimise lisameetmed</td><td>Lisätoimenpiteet riskien minimoimiseksi</td><td>Mesures additionnelles de réduction du risque</td><td>Bearta breise íoslaghdaithe riosca</td><td>Dodatne mjere minimizacije rizika</td><td>Kockázatminimalizálásra irányuló további intézkedések</td><td>Viðbótaraðgerðir til að lágmarka áhættu</td><td>Misure aggiuntive di minimizzazione del rischio</td><td>Papildomos rizikos mažinimo priemonės</td><td>Papildu riska mazināšanas pasākumi</td><td>Miżuri addizzjonali għall-minimizzazzjoni tar-riskji</td><td>Extra risicobeperkende maatregelen</td><td>Andre risikominimeringsaktiviteter</td><td>Dodatkowe działania w celu minimalizacji ryzyka</td><td>Medidas adicionais de minimização do risco</td><td>Măsuri suplimentare de reducere la minimum a riscului</td><td>Nadstavbové opatrenia na minimalizáciu rizika</td><td>Dodatni ukrepi za zmanjševanje tveganj</td><td>Ytterligare riskminimeringsåtgärder</td></tr><tr><td>200000029859</td><td>Задължение за провеждане на мерки след разрешаване за употреба</td><td>Povinnost uskutečnit poregistrační opatření</td><td>Forpligtelse til at gennemføre foranstaltninger efter udstedelse af markedsføringstilladelse</td><td>Verpflichtung zur Durchführung von Maßnahmen nach der Zulassung</td><td>Υποχρέωση λήψης μετεγκριτικών μέτρων</td><td>Obligation to conduct post-authorisation measures</td><td>Obligación de llevar a cabo medidas posautorización</td><td>Müügiloajärgsed kohustused</td><td>Velvoite toteuttaa myyntiluvan myöntämisen jälkeisiä toimenpiteitä</td><td>Obligation de mise en place de mesures post-autorisation</td><td>An oibleagáid bearta iar-údaraithe a dhéanamh</td><td>Obveza provođenja mjera nakon davanja odobrenja</td><td>Forgalomba hozatalt követő intézkedések teljesítésére vonatkozó speciális kötelezettség</td><td>Skylda til aðgerða eftir útgáfu markaðsleyfis</td><td>Obbligo di condurre attività post-autorizzative</td><td>Įpareigojimas vykdyti poregistracines užduotis</td><td>Saistības veikt pēcreģistrācijas pasākumus</td><td>Obbligu biex jitwettqu miżuri ta’ wara l-awtorizzazzjoni</td><td>Verplichting tot het nemen van maatregelen na toekenning van de handelsvergunning</td><td>Forpliktelse til å utføre tiltak etter autorisasjon</td><td>Zobowiązania do wypełnienia po wprowadzeniu do obrotu</td><td>Obrigação de concretizar as medidas de pós-autorização</td><td>Obligații pentru îndeplinirea măsurilor post-autorizare</td><td>Povinnosť vykonať postregistračné opatrenia</td><td>Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet</td><td>Skyldighet att vidta åtgärder efter godkännande för försäljning</td></tr><tr><td>200000029860</td><td>Д. КОНКРЕТНО ЗАДЪЛЖЕНИЕ ЗА ИЗПЪЛНЕНИЕ НА МЕРКИ СЛЕД [РАЗРЕШАВАНЕ ЗА УПОТРЕБА ПОД УСЛОВИЕ] [РАЗРЕШАВАНЕ ЗА УПОТРЕБА ПРИ ИЗВЪНРЕДНИ ОБСТОЯТЕЛСТВА]</td><td>E. ZVLÁŠTNÍ POVINNOST USKUTEČNIT POREGISTRAČNÍ OPATŘENÍ PRO [PODMÍNEČNOU REGISTRACI PŘÍPRAVKU] [REGISTRACI PŘÍPRAVKU ZA VÝJIMEČNÝCH OKOLNOSTÍ]</td><td>E. SÆRLIG FORPLIGTELSE TIL AT GENNEMFØRE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER GODKENDT UNDER [BETINGEDE OMSTÆNDIGHEDER] [SÆRLIGE VILKÅR]</td><td>E. SPEZIFISCHE VERPFLICHTUNG ZUM ABSCHLUSS VON MASSNAHMEN NACH DER ZULASSUNG [UNTER „BESONDEREN BEDINGUNGEN“] [UNTER „AUSSERGEWÖHNLICHEN UMSTÄNDEN“]</td><td>Ε. ΕΙΔΙΚΗ ΥΠΟΧΡΕΩΣΗ ΟΛΟΚΛΗΡΩΣΗΣ ΜΕΤΕΓΚΡΙΤΙΚΩΝ ΜΕΤΡΩΝ ΓΙΑ [ΤΗΝ ΑΔΕΙΑ ΚΥΚΛΟΦΟΡΙΑΣ ΜΕ ΕΓΚΡΙΣΗ ΥΠΟ ΟΡΟΥΣ] [ΤΗΝ ΑΔΕΙΑ ΚΥΚΛΟΦΟΡΙΑΣ ΥΠΟ ΕΞΑΙΡΕΤΙΚΕΣ ΠΕΡΙΣΤΑΣΕΙΣ]</td><td>E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR [THE CONDITIONAL MARKETING AUTHORISATION] [THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES</td><td>E. OBLIGACIÓN ESPECÍFICA DE LLEVAR A CABO MEDIDAS POSAUTORIZACIÓN EN RELACIÓN [CON UNA AUTORIZACIÓN DE COMERCIALIZACIÓN CONDICIONAL][CON UNA AUTORIZACIÓN DE COMERCIALIZACIÓN EN CIRCUNSTANCIAS EXCEPCIONALES]</td><td>E. ERIKOHUSTUSED [TINGIMUSLIKU MÜÜGILOA] [ERANDLIKEL ASJAOLUDEL VÄLJAANTUD MÜÜGILOA] JÄRGSETE MEETMETE TÄITMISEKS</td><td>E. ERITYISVELVOITE TOTEUTTAA MYYNTILUVAN MYÖNTÄMISEN JÄLKEISIÄ TOIMENPITEITÄ, KUN KYSEESSÄ ON [EHDOLLINEN MYYNTILUPA] [POIKKEUSOLOSUHTEISSA MYÖNNETTY MYYNTILUPA ]</td><td>E. OBLIGATION SPÉCIFIQUE RELATIVE AUX MESURES POST-AUTORISATION CONCERNANT [L’AUTORISATION DE MISE SUR LE MARCHÉ CONDITIONNELLE] [L’AUTORISATION DE MISE SUR LE MARCHÉ «SOUS CIRCONSTANCES EXCEPTIONNELLES»]</td><td>E. OIBLEAGÁID SHONRACH BEARTA IAR-ÚDARAITHE A DHÉANAMH FAOI CHOINNE [ÚDARÚ MARGAÍOCHTA COINNÍOLLACH] [ÚDARÚ MARGAÍOCHTA FAOI IMTHOSCA EISCEACHTÚLA]</td><td>E. POSEBNE OBVEZE ZA PROVEDBE MJERA NAKON DAVANJA ODOBRENJA KOD [UVJETNOG ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET] [ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET U IZNIMNIM OKOLNOSTIMA]</td><td>E. KÜLÖNLEGES KÖTELEZETTSÉGVÁLLALÁS FORGALOMBA HOZATALT KÖVETŐ INTÉZKEDÉSEK TELJESÍTÉSÉRE [FELTÉTELES FORGALOMBA HOZATALI ENGEDÉLY][KIVÉTELES KÖRÜLMÉNYEK KÖZÖTT MEGADOTT FORGALOMBA HOZATALI ENGEDÉLY] ESETÉN]</td><td>E. SÉRSTÖK SKYLDA TIL AÐ LJÚKA AÐGERÐUM EFTIR ÚTGÁFU [SKILYRTS MARKAÐSLEYFIS][MARKAÐSLEYFIS SEM GEFIÐ HEFUR VERIÐ ÚT SAMKVÆMT FERLI UM UNDANTEKNINGARTILVIK]</td><td>E. OBBLIGO SPECIFICO DI COMPLETARE LE ATTIVITA' POST-AUTORIZZATIVE PER [L’AUTORIZZAZIONE ALL’IMMISSIONE IN COMMERCIO SUBORDINATA A CONDIZIONI] [L’AUTORIZZAZIONE ALL’IMMISSIONE IN COMMERCIO RILASCIATA IN CIRCOSTANZE ECCEZIONALI]</td><td>E. SPECIFINIS ĮPAREIGOJIMAS ĮVYKDYTI POREGISTRACINES UŽDUOTIS [SĄLYGINĖS REGISTRACIJOS ATVEJU] [REGISTRACIJOS IŠIMTINĖMIS SĄLYGOMIS ATVEJU]</td><td>E. ĪPAŠAS SAISTĪBAS, LAI VEIKTU PĒCREĢISTRĀCIJAS PASĀKUMUS [ZĀLĒM, KAS REĢISTRĒTAS AR NOSACĪJUMIEM][ZĀLĒM, KAS REĢISTRĒTAS „IZŅĒMUMA KĀRTĀ”]</td><td>E. OBBLIGU SPEĊIFIKU BIEX MIŻURI TA’ WARA L-AWTORIZZAZJONI JIĠU KOMPLUTI GĦAL [L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ KONDIZZJONALI] [L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ TAĦT ĊIRKUSTANZI EĊĊEZZJONALI]</td><td>E. SPECIFIEKE VERPLICHTINGEN WAARAAN NA TOEKENNING VAN EEN [VOORWAARDELIJKE VERGUNNING] [VERGUNNING ONDER UITZONDERLIJKE VOORWAARDEN] MOET WORDEN VOLDAAN</td><td>E. SPESIFIKK FORPLIKTELSE TIL Å FULLFØRE TILTAK ETTER AUTORISASJON FOR [DEN BETINGEDE MARKEDSFØRINGSTILLATELSEN] [MARKEDSFØRINGSTILLATELSEN GITT PÅ SÆRSKILT GRUNNLAG]</td><td>E. SZCZEGÓLNE ZOBOWIĄZANIA DO WYKONANIA PO WPROWADZENIU DO OBROTU, GDY POZWOLENIE NA WPROWADZENIE DO OBROTU [JEST UDZIELONE W PROCEDURZE DOPUSZCZENIA WARUNKOWEGO] [JEST UDZIELONE W PROCEDURZE DOPUSZCZENIA W WYJĄTKOWYCH OKOLICZNOŚCIACH]</td><td>E. OBRIGAÇÕES ESPECÍFICAS PARA COMPLETAR AS MEDIDAS DE PÓS-AUTORIZAÇÃO [DA AUTORIZAÇÃO DE INTRODUÇÃO NO MERCADO CONDICIONAL] [DA AUTORIZAÇÃO DE INTRODUÇÃO NO MERCADO EM CIRCUNSTÂNCIAS EXCECIONAIS]</td><td>E. OBLIGAȚII SPECIFICE PENTRU ÎNDEPLINIREA MĂSURILOR POST-AUTORIZARE ÎN CAZUL [AUTORIZĂRII PRIN APROBARE CONDIȚIONATĂ][AUTORIZĂRII ÎN CONDIȚII EXCEPȚIONALE]</td><td>E. OSOBITNÉ POŽIADAVKY NA SPLNENIE POSTREGISTRAČNÝCH OPATRENÍ [PRI REGISTRÁCII S PODMIENKOU] [PRI REGISTRÁCII ZA MIMORIADNYCH OKOLNOSTÍ]</td><td>E. 	SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI [POGOJNEGA DOVOLJENJA ZA PROMET Z ZDRAVILOM] [DOVOLJENJA ZA PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH]</td><td>E. SÄRSKILDA VILLKOR SOM SKA KOMPLETTERA ÅTAGANDEN EFTER GODKÄNNANDET FÖR FÖRSÄLJNING [FÖR DET VILLKORADE GODKÄNNANDET] [FÖR GODKÄNNANDET I UNDANTAGSFALL]</td></tr><tr><td>200000029861</td><td>ДАННИ ВЪРХУ ОПАКОВКАТА</td><td>OZNAČENÍ NA OBALU</td><td>ETIKETTERING</td><td>ETIKETTIERUNG</td><td>ΕΠΙΣΗΜΑΝΣΗ</td><td>LABELLING</td><td>ETIQUETADO</td><td>PAKENDI MÄRGISTUS</td><td>MYYNTIPÄÄLLYSMERKINNÄT</td><td>ÉTIQUETAGE</td><td>LIPÉADÚ</td><td>OZNAČIVANJE</td><td>CÍMKESZÖVEG</td><td>ÁLETRANIR</td><td>ETICHETTATURA</td><td>ŽENKLINIMAS</td><td>MARĶĒJUMA TEKSTS</td><td>TIKKETTAR</td><td>ETIKETTERING</td><td>MERKING</td><td>OZNAKOWANIE OPAKOWAŃ</td><td>ROTULAGEM</td><td>ETICHETAREA</td><td>OZNAČENIE OBALU</td><td>OZNAČEVANJE</td><td>MÄRKNING</td></tr><tr><td>200000029862</td><td>ДАННИ, КОИТО ТРЯБВА ДА СЪДЪРЖА [ВТОРИЧНАТА ОПАКОВКА] [И] [ПЪРВИЧНАТА ОПАКОВКА] {ВИД/ТИП}</td><td>ÚDAJE UVÁDĚNÉ NA [VNĚJŠÍM OBALU] [A] [VNITŘNÍM OBALU] {DRUH/TYP}</td><td>MÆRKNING, DER SKAL ANFØRES [PÅ DEN YDRE EMBALLAGE] [OG] [PÅ DEN INDRE EMBALLAGE] {ART/TYPE}</td><td>ANGABEN [AUF DER ÄUSSEREN UMHÜLLUNG] [UND] [AUF DEM BEHÄLTNIS] {ART/TYP}</td><td>ΕΝΔΕΙΞΕΙΣ ΠΟΥ ΠΡΕΠΕΙ ΝΑ ΑΝΑΓΡΑΦΟΝΤΑΙ [ΣΤΗΝ ΕΞΩΤΕΡΙΚΗ ΣΥΣΚΕΥΑΣΙΑ] [ΚΑΙ] [ ΣΤΗ ΣΤΟΙΧΕΙΩΔΗ ΣΥΣΚΕΥΑΣΙΑ] {ΜΟΡΦΗ/ΕΙΔΟΣ}</td><td>PARTICULARS TO APPEAR ON [THE OUTER PACKAGING] [AND] [THE IMMEDIATE PACKAGING] {NATURE/TYPE}</td><td>INFORMACIÓN QUE DEBE FIGURAR EN [EL EMBALAJE EXTERIOR][Y][EL ACONDICIONAMIENTO PRIMARIO] {NATURALEZA/TIPO}</td><td>[VÄLISPAKENDIL] [JA] [SISEPAKENDIL] PEAVAD OLEMA JÄRGMISED ANDMED {OLEMUS/TÜÜP}</td><td>[ULKOPAKKAUKSESSA] [JA] [SISÄPAKKAUKSESSA] ON OLTAVA SEURAAVAT MERKINNÄT {PAKKAUSTYYPPI}</td><td>MENTIONS DEVANT FIGURER SUR [L’EMBALLAGE EXTÉRIEUR] [ET SUR] [LE CONDITIONNEMENT PRIMAIRE] {NATURE/TYPE}</td><td>SONRAÍ LE CUR AR [AN bhFORPHACÁISTÍOCHT] [AGUS] [AN NEASPHACÁISTÍOCHT] {CINEÁL}</td><td>PODACI KOJI SE MORAJU NALAZITI NA [ VANJSKOM PAKIRANJU] [I] [UNUTARNJEM PAKIRANJU] {VRSTA/TIP}</td><td>A [KÜLSŐ CSOMAGOLÁSON][ÉS][A KÖZVETLEN CSOMAGOLÁSON] FELTÜNTETENDŐ ADATOK {A CSOMAGOLÁS TÍPUSA}</td><td>UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á [YTRI UMBÚÐUM] [OG] [INNRI UMBÚÐUM] {GERÐ/TEGUND}</td><td>INFORMAZIONI DA APPORRE [SUL CONFEZIONAMENTO SECONDARIO] [E] [SUL CONFEZIONAMENTO PRIMARIO] {NATURA/TIPO}</td><td>INFORMACIJA ANT [IŠORINĖS] [IR] [VIDINĖS] PAKUOTĖS {POBŪDIS/TIPAS}</td><td>INFORMĀCIJA, KAS JĀNORĀDA UZ [ĀRĒJĀ IEPAKOJUMA ] [UN] [ UZ TIEŠĀ IEPAKOJUMA] {VEIDS/TIPS}</td><td>TAGĦRIF LI GĦANDU JIDHER FUQ [IL-PAKKETT TA’ BARRA] [U] [IL-PAKKETT LI JMISS MAL-PRODOTT] {NATURA/TIP}</td><td>GEGEVENS DIE OP [DE BUITENVERPAKKING][EN] [DE PRIMAIRE VERPAKKING] MOETEN WORDEN VERMELD {AARD/TYPE}</td><td>OPPLYSNINGER SOM SKAL ANGIS PÅ [YTRE EMBALLASJE][OG] [INDRE EMBALLASJE] {TYPE}</td><td>INFORMACJE ZAMIESZCZANE NA [OPAKOWANIACH ZEWNĘTRZNYCH] [ORAZ] [OPAKOWANIACH BEZPOŚREDNICH] {RODZAJ OPAKOWANIA}</td><td>INDICAÇÕES A INCLUIR [NO ACONDICIONAMENTO SECUNDÁRIO] [E] [NO ACONDICIONAMENTO PRIMÁRIO] {NATUREZA/TIPO}</td><td>INFORMAȚII CARE TREBUIE SĂ APARĂ PE [AMBALAJUL SECUNDAR][ȘI][AMBALAJUL PRIMAR] {NATURA/TIPUL AMBALAJULUI}</td><td>ÚDAJE, KTORÉ MAJÚ BYŤ UVEDENÉ NA [VONKAJŠOM OBALE] [A] [VNÚTORNOM OBALE] {DRUH/TYP}</td><td>PODATKI NA [ZUNANJI OVOJNINI] [IN] [PRIMARNI OVOJNINI] {VRSTA/TIP}</td><td>UPPGIFTER SOM SKA FINNAS PÅ [YTTRE FÖRPACKNINGEN] [OCH PÅ] [INNERFÖRPACKNINGEN] {FÖRPACKNINGSTYP}</td></tr><tr><td>200000029863</td><td>1. ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ</td><td>1. NÁZEV LÉČIVÉHO PŘÍPRAVKU</td><td>1. LÆGEMIDLETS NAVN</td><td>1. BEZEICHNUNG DES ARZNEIMITTELS</td><td>1. ΟΝΟΜΑΣΙΑ ΤΟΥ ΦΑΡΜΑΚΕΥΤΙΚΟΥ ΠΡΟΪΟΝΤΟΣ</td><td>1. NAME OF THE MEDICINAL PRODUCT</td><td>1. NOMBRE DEL MEDICAMENTO</td><td>1. RAVIMPREPARAADI NIMETUS</td><td>1. LÄÄKEVALMISTEEN NIMI</td><td>1. DÉNOMINATION DU MÉDICAMENT</td><td>1. AINM AN TÁIRGE ÍOCSHLÁINTE</td><td>1. NAZIV LIJEKA</td><td>1. A GYÓGYSZER NEVE</td><td>1. HEITI LYFS</td><td>1. DENOMINAZIONE DEL MEDICINALE</td><td>1. VAISTINIO PREPARATO PAVADINIMAS</td><td>1. ZĀĻU NOSAUKUMS</td><td>1. ISEM TAL-PRODOTT MEDIĊINALI</td><td>1. NAAM VAN HET GENEESMIDDEL</td><td>1. LEGEMIDLETS NAVN</td><td>1. NAZWA PRODUKTU LECZNICZEGO</td><td>1. NOME DO MEDICAMENTO</td><td>1. DENUMIREA COMERCIALĂ A MEDICAMENTULUI</td><td>1. NÁZOV LIEKU</td><td>1. IME ZDRAVILA</td><td>1. LÄKEMEDLETS NAMN</td></tr><tr><td>200000029864</td><td>2. ОБЯВЯВАНЕ НА АКТИВНОТО(ИТЕ) ВЕЩЕСТВО(А)</td><td>2. OBSAH LÉČIVÉ LÁTKY/LÉČIVÝCH LÁTEK</td><td>2. ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER</td><td>2. WIRKSTOFF(E)</td><td>2. ΣΥΝΘΕΣΗ ΣΕ ΔΡΑΣΤΙΚΗ(ΕΣ) ΟΥΣΙΑ(ΕΣ)</td><td>2. STATEMENT OF ACTIVE SUBSTANCE(S)</td><td>2. PRINCIPIO(S) ACTIVO(S)</td><td>2. TOIMEAINE(TE) SISALDUS</td><td>2. VAIKUTTAVA(T) AINE(ET)</td><td>2. COMPOSITION EN SUBSTANCE(S) ACTIVE(S)</td><td>2. RÁITEAS FAOI NA SUBSTAINTÍ GNÍOMHACHA</td><td>2. NAVOĐENJE DJELATNE(IH) TVARI</td><td>2. HATÓANYAG(OK) MEGNEVEZÉSE</td><td>2. VIRK(T) EFNI</td><td>2. COMPOSIZIONE QUALITATIVA E QUANTITATIVA IN TERMINI DI PRINCIPIO(I) ATTIVO(I)</td><td>2. VEIKLIOJI (-IOS) MEDŽIAGA (-OS) IR JOS (-Ų) KIEKIS (-IAI)</td><td>2. AKTĪVĀS(-O) VIELAS(-U) NOSAUKUMS(-I) UN DAUDZUMS(-I)</td><td>2. DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)</td><td>2. GEHALTE AAN WERKZAME STOF(FEN)</td><td>2. DEKLARASJON AV VIRKESTOFF(ER)</td><td>2. ZAWARTOŚĆ [SUBSTANCJI CZYNNEJ] [SUBSTANCJI CZYNNYCH]</td><td>2. DESCRIÇÃO DA(S) SUBSTÂNCIA(S) ATIVA(S)</td><td>2. DECLARAREA SUBSTANȚEI(SUBSTANȚELOR) ACTIVE</td><td>2. LIEČIVO (LIEČIVÁ)</td><td>2. NAVEDBA ENE ALI VEČ UČINKOVIN</td><td>2. DEKLARATION AV AKTIV(A) SUBSTANS(ER)</td></tr><tr><td>200000029865</td><td>3. СПИСЪК НА ПОМОЩНИТЕ ВЕЩЕСТВА</td><td>3. SEZNAM POMOCNÝCH LÁTEK</td><td>3. LISTE OVER HJÆLPESTOFFER</td><td>3. SONSTIGE BESTANDTEILE</td><td>3. ΚΑΤΑΛΟΓΟΣ ΕΚΔΟΧΩΝ</td><td>3. LIST OF EXCIPIENTS</td><td>3. LISTA DE EXCIPIENTES</td><td>3. ABIAINED</td><td>3. LUETTELO APUAINEISTA</td><td>3. LISTE DES EXCIPIENTS</td><td>3. LIOSTA DE NA TÁMHÁIN</td><td>3. POPIS POMOĆNIH TVARI</td><td>3. SEGÉDANYAGOK FELSOROLÁSA</td><td>3. HJÁLPAREFNI</td><td>3. ELENCO DEGLI ECCIPIENTI</td><td>3. PAGALBINIŲ MEDŽIAGŲ SĄRAŠAS</td><td>3. PALĪGVIELU SARAKSTS</td><td>3. LISTA TA’ EĊĊIPJENTI</td><td>3. LIJST VAN HULPSTOFFEN</td><td>3. LISTE OVER HJELPESTOFFER</td><td>3. WYKAZ SUBSTANCJI POMOCNICZYCH</td><td>3. LISTA DOS EXCIPIENTES</td><td>3. LISTA EXCIPIENȚILOR</td><td>3. ZOZNAM POMOCNÝCH LÁTOK</td><td>3. SEZNAM POMOŽNIH SNOVI</td><td>3. FÖRTECKNING ÖVER HJÄLPÄMNEN</td></tr><tr><td>200000029866</td><td>4. ЛЕКАРСТВЕНА ФОРМА И КОЛИЧЕСТВО В ЕДНА ОПАКОВКА</td><td>4. LÉKOVÁ FORMA A OBSAH BALENÍ</td><td>4. LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE)</td><td>4. DARREICHUNGSFORM UND INHALT</td><td>4. ΦΑΡΜΑΚΟΤΕΧΝΙΚΗ ΜΟΡΦΗ ΚΑΙ ΠΕΡΙΕΧΟΜΕΝΟ</td><td>4. PHARMACEUTICAL FORM AND CONTENTS</td><td>4. FORMA FARMACÉUTICA Y CONTENIDO DEL ENVASE</td><td>4. RAVIMVORM JA PAKENDI SUURUS</td><td>4. LÄÄKEMUOTO JA SISÄLLÖN MÄÄRÄ</td><td>4. FORME PHARMACEUTIQUE ET CONTENU</td><td>4. FOIRM CHÓGAISÍOCHTA AGUS INNEACHAR</td><td>4. FARMACEUTSKI OBLIK I SADRŽAJ</td><td>4. GYÓGYSZERFORMA ÉS TARTALOM</td><td>4. LYFJAFORM OG INNIHALD</td><td>4. FORMA FARMACEUTICA E CONTENUTO</td><td>4. FARMACINĖ FORMA IR KIEKIS PAKUOTĖJE</td><td>4. ZĀĻU FORMA UN SATURS</td><td>4. GĦAMLA FARMAĊEWTIKA U KONTENUT</td><td>4. FARMACEUTISCHE VORM EN INHOUD</td><td>4. LEGEMIDDELFORM OG INNHOLD (PAKNINGSSTØRRELSE)</td><td>4. POSTAĆ FARMACEUTYCZNA I ZAWARTOŚĆ OPAKOWANIA</td><td>4. FORMA FARMACÊUTICA E CONTEÚDO</td><td>4. FORMA FARMACEUTICĂ ȘI CONȚINUTUL</td><td>4. LIEKOVÁ FORMA A OBSAH</td><td>4. FARMACEVTSKA OBLIKA IN VSEBINA</td><td>4. LÄKEMEDELSFORM OCH FÖRPACKNINGSSTORLEK</td></tr><tr><td>200000029867</td><td>5. НАЧИН НА ПРИЛОЖЕНИЕ И ПЪТ(ИЩА) НА ВЪВЕЖДАНЕ</td><td>5. ZPŮSOB A CESTA/CESTY PODÁNÍ</td><td>5. ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E)</td><td>5. HINWEISE ZUR UND ART(EN) DER ANWENDUNG</td><td>5. ΤΡΟΠΟΣ ΚΑΙ ΟΔΟΣ(ΟΙ) ΧΟΡΗΓΗΣΗΣ</td><td>5. METHOD AND ROUTE(S) OF ADMINISTRATION</td><td>5. FORMA Y VÍA(S) DE ADMINISTRACIÓN</td><td>5. MANUSTAMISVIIS JA -TEE(D)</td><td>5. ANTOTAPA JA TARVITTAESSA ANTOREITTI (ANTOREITIT)</td><td>5. MODE ET VOIE(S) D’ADMINISTRATION</td><td>5. MODH AGUS BEALACH/BEALAÍ TABHARTHA</td><td>5. NAČIN I PUT(EVI) PRIMJENE LIJEKA</td><td>5. AZ ALKALMAZÁSSAL KAPCSOLATOS TUDNIVALÓK ÉS AZ ALKALMAZÁS MÓDJA(I)</td><td>5. AÐFERÐ VIÐ LYFJAGJÖF OG ÍKOMULEIÐ(IR)</td><td>5. MODO E VIA(E) DI SOMMINISTRAZIONE</td><td>5. VARTOJIMO METODAS IR BŪDAS (-AI)</td><td>5. LIETOŠANAS UN IEVADĪŠANAS VEIDS(-I)</td><td>5. MOD TA’ KIF U MNEJN JINGĦATA</td><td>5. WIJZE VAN GEBRUIK EN TOEDIENINGSWEG(EN)</td><td>5. ADMINISTRASJONSMÅTE OG -VEI(ER)</td><td>5. SPOSÓB I [DROGA] [DROGI] PODANIA</td><td>5. MODO E VIA(S) DE ADMINISTRAÇÃO</td><td>5. MODUL ȘI CALEA(CĂILE) DE ADMINISTRARE</td><td>5. SPÔSOB A CESTA (CESTY) PODÁVANIA</td><td>5. POSTOPEK IN POT(I) UPORABE ZDRAVILA</td><td>5. ADMINISTRERINGSSÄTT OCH ADMINISTRERINGSVÄG</td></tr><tr><td>200000029868</td><td>6. СПЕЦИАЛНО ПРЕДУПРЕЖДЕНИЕ, ЧЕ ЛЕКАРСТВЕНИЯТ ПРОДУКТ ТРЯБВА ДА СЕ СЪХРАНЯВА НА МЯСТО ДАЛЕЧЕ ОТ ПОГЛЕДА И ДОСЕГА НА ДЕЦА</td><td>6. ZVLÁŠTNÍ UPOZORNĚNÍ, ŽE LÉČIVÝ PŘÍPRAVEK MUSÍ BÝT UCHOVÁVÁN MIMO DOHLED A DOSAH DĚTÍ</td><td>6. SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN</td><td>6. WARNHINWEIS, DASS DAS ARZNEIMITTEL FÜR KINDER UNZUGÄNGLICH AUFZUBEWAHREN IST</td><td>6. ΕΙΔΙΚΗ ΠΡΟΕΙΔΟΠΟΙΗΣΗ ΣΥΜΦΩΝΑ ΜΕ ΤΗΝ ΟΠΟΙΑ ΤΟ ΦΑΡΜΑΚΕΥΤΙΚΟ ΠΡΟΪΟΝ ΠΡΕΠΕΙ ΝΑ ΦΥΛΑΣΣΕΤΑΙ ΣΕ ΘΕΣΗ ΤΗΝ ΟΠΟΙΑ ΔΕΝ ΒΛΕΠΟΥΝ ΚΑΙ ΔΕΝ ΠΡΟΣΕΓΓΙΖΟΥΝ ΤΑ ΠΑΙΔΙΑ</td><td>6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN</td><td>6. ADVERTENCIA ESPECIAL DE QUE EL MEDICAMENTO DEBE MANTENERSE FUERA DE LA VISTA Y DEL ALCANCE DE LOS NIÑOS</td><td>6. ERIHOIATUS, ET RAVIMIT TULEB HOIDA LASTE EEST VARJATUD JA KÄTTESAAMATUS KOHAS</td><td>6. ERITYISVAROITUS VALMISTEEN SÄILYTTÄMISESTÄ POISSA LASTEN ULOTTUVILTA JA NÄKYVILTÄ</td><td>6. MISE EN GARDE SPÉCIALE INDIQUANT QUE LE MÉDICAMENT DOIT ÊTRE CONSERVÉ HORS DE VUE ET DE PORTÉE DES ENFANTS</td><td>6. RABHADH SPEISIALTA GO gCAITHFEAR AN TÁIRGE ÍOCSHLÁINTE A CHOIMEÁD AS RADHARC AGUS AS AIMSIÚ LEANAÍ</td><td>6. POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN POGLEDA I DOHVATA DJECE</td><td>6. KÜLÖN FIGYELMEZTETÉS, MELY SZERINT A GYÓGYSZERT GYERMEKEKTŐL ELZÁRVA KELL TARTANI</td><td>6. SÉRSTÖK VARNAÐARORÐ UM AÐ LYFIÐ SKULI GEYMT ÞAR SEM BÖRN HVORKI NÁ TIL NÉ SJÁ</td><td>6. AVVERTENZA PARTICOLARE CHE PRESCRIVA DI TENERE IL MEDICINALE FUORI DALLA VISTA E DALLA PORTATA DEI BAMBINI</td><td>6. SPECIALUS ĮSPĖJIMAS, KAD VAISTINĮ PREPARATĄ BŪTINA LAIKYTI VAIKAMS NEPASTEBIMOJE IR NEPASIEKIAMOJE VIETOJE</td><td>6. ĪPAŠI BRĪDINĀJUMI PAR ZĀĻU UZGLABĀŠANU BĒRNIEM NEREDZAMĀ UN NEPIEEJAMĀ VIETĀ</td><td>6. TWISSIJA SPEĊJALI LI L-PRODOTT MEDIĊINALI GĦANDU JINŻAMM FEJN MA JIDHIRX U MA JINTLAĦAQX MIT-TFAL</td><td>6. EEN SPECIALE WAARSCHUWING DAT HET GENEESMIDDEL BUITEN HET ZICHT EN BEREIK VAN KINDEREN DIENT TE WORDEN GEHOUDEN</td><td>6. ADVARSEL OM AT LEGEMIDLET SKAL OPPBEVARES UTILGJENGELIG FOR BARN</td><td>6. OSTRZEŻENIE DOTYCZĄCE PRZECHOWYWANIA PRODUKTU LECZNICZEGO W MIEJSCU NIEWIDOCZNYM I NIEDOSTĘPNYM DLA DZIECI</td><td>6. ADVERTÊNCIA ESPECIAL DE QUE O MEDICAMENTO DEVE SER MANTIDO FORA DA VISTA E DO ALCANCE DAS CRIANÇAS</td><td>6. ATENȚIONARE SPECIALĂ PRIVIND FAPTUL CĂ MEDICAMENTUL NU TREBUIE PĂSTRAT LA VEDEREA ȘI ÎNDEMÂNA COPIILOR</td><td>6. ŠPECIÁLNE UPOZORNENIE, ŽE LIEK SA MUSÍ UCHOVÁVAŤ MIMO DOHĽADU A DOSAHU DETÍ</td><td>6. POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK</td><td>6. SÄRSKILD VARNING OM ATT LÄKEMEDLET MÅSTE FÖRVARAS UTOM SYN- OCH RÄCKHÅLL FÖR BARN</td></tr><tr><td>200000029869</td><td>7. ДРУГИ СПЕЦИАЛНИ ПРЕДУПРЕЖДЕНИЯ, АКО Е НЕОБХОДИМО</td><td>7. DALŠÍ ZVLÁŠTNÍ UPOZORNĚNÍ, POKUD JE POTŘEBNÉ</td><td>7. EVENTUELLE ANDRE SÆRLIGE ADVARSLER</td><td>7. WEITERE WARNHINWEISE, FALLS ERFORDERLICH</td><td>7. ΑΛΛΗ(ΕΣ) ΕΙΔΙΚΗ(ΕΣ) ΠΡΟΕΙΔΟΠΟΙΗΣΗ(ΕΙΣ), ΕΑΝ ΕΙΝΑΙ ΑΠΑΡΑΙΤΗΤΗ(ΕΣ)</td><td>7. OTHER SPECIAL WARNING(S), IF NECESSARY</td><td>7. OTRA(S) ADVERTENCIA(S) ESPECIAL(ES), SI ES NECESARIO</td><td>7. TEISED ERIHOIATUSED (VAJADUSEL)</td><td>7. MUU ERITYISVAROITUS (MUUT ERITYISVAROITUKSET), JOS TARPEEN</td><td>7. AUTRE(S) MISE(S) EN GARDE SPÉCIALE(S), SI NÉCESSAIRE</td><td>7. RABHADH/RABHAIDH SPEISIALTA EILE, MÁS GÁ</td><td>7. DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO</td><td>7. TOVÁBBI FIGYELMEZTETÉS(EK), AMENNYIBEN SZÜKSÉGES</td><td>7. ÖNNUR SÉRSTÖK VARNAÐARORÐ, EF MEÐ ÞARF</td><td>7. ALTRA(E) AVVERTENZA(E) PARTICOLARE(I), SE NECESSARIO</td><td>7. KITAS (-I) SPECIALUS (-ŪS) ĮSPĖJIMAS (-AI) (JEI REIKIA)</td><td>7. CITI ĪPAŠI BRĪDINĀJUMI, JA NEPIECIEŠAMS</td><td>7. TWISSIJA(IET) SPEĊJALI OĦRA, JEKK MEĦTIEĠA</td><td>7. ANDERE SPECIALE WAARSCHUWING(EN), INDIEN NODIG</td><td>7. EVENTUELLE ANDRE SPESIELLE ADVARSLER</td><td>7. INNE OSTRZEŻENIA SPECJALNE, JEŚLI KONIECZNE</td><td>7. OUTRAS ADVERTÊNCIAS ESPECIAIS, SE NECESSÁRIO</td><td>7. ALTĂ(E) ATENȚIONARE(ĂRI) SPECIALĂ(E), DACĂ ESTE(SUNT) NECESARĂ(E)</td><td>7. INÉ ŠPECIÁLNE UPOZORNENIE (UPOZORNENIA), AK JE TO POTREBNÉ</td><td>7. DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA</td><td>7. ÖVRIGA SÄRSKILDA VARNINGAR OM SÅ ÄR NÖDVÄNDIGT</td></tr><tr><td>200000029870</td><td>8. ДАТА НА ИЗТИЧАНЕ НА СРОКА НА ГОДНОСТ</td><td>8. POUŽITELNOST</td><td>8. UDLØBSDATO</td><td>8. VERFALLDATUM</td><td>8. ΗΜΕΡΟΜΗΝΙΑ ΛΗΞΗΣ</td><td>8. EXPIRY DATE</td><td>8. FECHA DE CADUCIDAD</td><td>8. KÕLBLIKKUSAEG</td><td>8. VIIMEINEN KÄYTTÖPÄIVÄMÄÄRÄ</td><td>8. DATE DE PÉREMPTION</td><td>8. DÁTA ÉAGA</td><td>8. ROK VALJANOSTI</td><td>8. LEJÁRATI IDŐ</td><td>8. FYRNINGARDAGSETNING</td><td>8. DATA DI SCADENZA</td><td>8. TINKAMUMO LAIKAS</td><td>8. DERĪGUMA TERMIŅŠ</td><td>8. DATA TA’ SKADENZA</td><td>8. UITERSTE GEBRUIKSDATUM</td><td>8. UTLØPSDATO</td><td>8. TERMIN WAŻNOŚCI</td><td>8. PRAZO DE VALIDADE</td><td>8. DATA DE EXPIRARE</td><td>8. DÁTUM EXSPIRÁCIE</td><td>8. DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA</td><td>8. UTGÅNGSDATUM</td></tr><tr><td>200000029871</td><td>9. СПЕЦИАЛНИ УСЛОВИЯ НА СЪХРАНЕНИЕ</td><td>9. ZVLÁŠTNÍ PODMÍNKY PRO UCHOVÁVÁNÍ</td><td>9. SÆRLIGE OPBEVARINGSBETINGELSER</td><td>9. BESONDERE VORSICHTSMASSNAHMEN FÜR DIE AUFBEWAHRUNG</td><td>9. ΕΙΔΙΚΕΣ ΣΥΝΘΗΚΕΣ ΦΥΛΑΞΗΣ</td><td>9. SPECIAL STORAGE CONDITIONS</td><td>9. CONDICIONES ESPECIALES DE CONSERVACIÓN</td><td>9. SÄILITAMISE ERITINGIMUSED</td><td>9. ERITYISET SÄILYTYSOLOSUHTEET</td><td>9. PRÉCAUTIONS PARTICULIÈRES DE CONSERVATION</td><td>9. DÁLAÍ SPEISIALTA STÓRÁLA</td><td>9. POSEBNE MJERE ČUVANJA</td><td>9. KÜLÖNLEGES TÁROLÁSI ELŐÍRÁSOK</td><td>9. SÉRSTÖK GEYMSLUSKILYRÐI</td><td>9. PRECAUZIONI PARTICOLARI PER LA CONSERVAZIONE</td><td>9. SPECIALIOS LAIKYMO SĄLYGOS</td><td>9. ĪPAŠI UZGLABĀŠANAS NOSACĪJUMI</td><td>9. KONDIZZJONIJIET SPEĊJALI TA’ KIF JINĦAŻEN</td><td>9. BIJZONDERE VOORZORGSMAATREGELEN VOOR DE BEWARING</td><td>9. OPPBEVARINGSBETINGELSER</td><td>9. WARUNKI PRZECHOWYWANIA</td><td>9. CONDIÇÕES ESPECIAIS DE CONSERVAÇÃO</td><td>9. CONDIȚII SPECIALE DE PĂSTRARE</td><td>9. ŠPECIÁLNE PODMIENKY NA UCHOVÁVANIE</td><td>9. POSEBNA NAVODILA ZA SHRANJEVANJE</td><td>9. SÄRSKILDA FÖRVARINGSANVISNINGAR</td></tr><tr><td>200000029872</td><td>10. СПЕЦИАЛНИ ПРЕДПАЗНИ МЕРКИ ПРИ ИЗХВЪРЛЯНЕ НА НЕИЗПОЛЗВАНА ЧАСТ ОТ ЛЕКАРСТВЕНИТЕ ПРОДУКТИ ИЛИ ОТПАДЪЧНИ МАТЕРИАЛИ ОТ ТЯХ, АКО СЕ ИЗИСКВАТ ТАКИВА</td><td>10. ZVLÁŠTNÍ OPATŘENÍ PRO LIKVIDACI NEPOUŽITÝCH LÉČIVÝCH PŘÍPRAVKŮ NEBO ODPADU Z NICH, POKUD JE TO VHODNÉ</td><td>10. EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKE ANVENDT LÆGEMIDDEL SAMT AFFALD HERAF</td><td>10. GEGEBENENFALLS BESONDERE VORSICHTSMASSNAHMEN FÜR DIE BESEITIGUNG VON NICHT VERWENDETEM ARZNEIMITTEL ODER DAVON STAMMENDEN ABFALLMATERIALIEN</td><td>10.	ΙΔΙΑΙΤΕΡΕΣ ΠΡΟΦΥΛΑΞΕΙΣ ΓΙΑ ΤΗΝ ΑΠΟΡΡΙΨΗ ΤΩΝ ΜΗ ΧΡΗΣΙΜΟΠΟΙΗΘΕΝΤΩΝ ΦΑΡΜΑΚΕΥΤΙΚΩΝ ΠΡΟΪΟΝΤΩΝ Ή ΤΩΝ ΥΠΟΛΕΙΜΜΑΤΩΝ ΠΟΥ ΠΡΟΕΡΧΟΝΤΑΙ ΑΠΟ ΑΥΤΑ, ΕΦΟΣΟΝ ΑΠΑΙΤΕΙΤΑΙ</td><td>10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE</td><td>10. PRECAUCIONES ESPECIALES DE ELIMINACIÓN DEL MEDICAMENTO NO UTILIZADO Y DE LOS MATERIALES DERIVADOS DE SU USO, CUANDO CORRESPONDA</td><td>10. ERINÕUDED KASUTAMATA JÄÄNUD RAVIMPREPARAADI VÕI SELLEST TEKKINUD JÄÄTMEMATERJALI HÄVITAMISEKS, VASTAVALT VAJADUSELE</td><td>10. ERITYISET VAROTOIMET KÄYTTÄMÄTTÖMIEN LÄÄKEVALMISTEIDEN TAI NIISTÄ PERÄISIN OLEVAN JÄTEMATERIAALIN HÄVITTÄMISEKSI, JOS TARPEEN</td><td>10. PRÉCAUTIONS PARTICULIÈRES D’ÉLIMINATION DES MÉDICAMENTS NON UTILISÉS OU DES DÉCHETS PROVENANT DE CES MÉDICAMENTS S’IL Y A LIEU</td><td>10. RÉAMHCHÚRAIMÍ SPEISIALTA MAIDIR LE DIÚSCAIRT TÁIRGÍ ÍOCSHLÁINTE NEAMHÚSÁIDTE NÓ ÁBHAR DRAMHAÍOLA DÍORTHAITHE Ó NA TÁIRGÍ ÍOCSHLÁINTE SIN, MÁS IOMCHUÍ</td><td>10. POSEBNE MJERE ZA ZBRINJAVANJE NEISKORIŠTENOG LIJEKA ILI OTPADNIH MATERIJALA KOJI POTJEČU OD LIJEKA, AKO JE POTREBNO</td><td>10. KÜLÖNLEGES ÓVINTÉZKEDÉSEK A FEL NEM HASZNÁLT GYÓGYSZEREK VAGY AZ ILYEN TERMÉKEKBŐL KELETKEZETT HULLADÉKANYAGOK ÁRTALMATLANNÁ TÉTELÉRE, HA ILYENEKRE SZÜKSÉG VAN</td><td>10. SÉRSTAKAR VARÚÐARRÁÐSTAFANIR VIÐ FÖRGUN LYFJALEIFA EÐA ÚRGANGS VEGNA LYFSINS ÞAR SEM VIÐ Á</td><td>10. PRECAUZIONI PARTICOLARI PER LO SMALTIMENTO DEL MEDICINALE NON UTILIZZATO O DEI RIFIUTI DERIVATI DA TALE MEDICINALE, SE NECESSARIO</td><td>10. SPECIALIOS ATSARGUMO PRIEMONĖS DĖL NESUVARTOTO VAISTINIO PREPARATO AR JO ATLIEKŲ TVARKYMO (JEI REIKIA)</td><td>10. ĪPAŠI PIESARDZĪBAS PASĀKUMI, IZNĪCINOT NEIZLIETOTĀS ZĀLES VAI IZMANTOTOS MATERIĀLUS, KAS BIJUŠI SASKARĒ AR ŠĪM ZĀLĒM, JA PIEMĒROJAMS</td><td>10. PREKAWZJONIJIET SPEĊJALI GĦAR-RIMI TA’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN</td><td>10. BIJZONDERE VOORZORGSMAATREGELEN VOOR HET VERWIJDEREN VAN NIET-GEBRUIKTE GENEESMIDDELEN OF DAARVAN AFGELEIDE AFVALSTOFFEN (INDIEN VAN TOEPASSING)</td><td>10. EVENTUELLE SPESIELLE FORHOLDSREGLER VED DESTRUKSJON AV UBRUKTE LEGEMIDLER ELLER AVFALL</td><td>10. SPECJALNE ŚRODKI OSTROŻNOŚCI DOTYCZĄCE USUWANIA NIEZUŻYTEGO PRODUKTU LECZNICZEGO LUB POCHODZĄCYCH Z NIEGO ODPADÓW, JEŚLI WŁAŚCIWE</td><td>10. CUIDADOS ESPECIAIS QUANTO À ELIMINAÇÃO DO MEDICAMENTO NÃO UTILIZADO OU DOS RESÍDUOS PROVENIENTES DESSE MEDICAMENTO, SE APLICÁVEL</td><td>10. PRECAUȚII SPECIALE PRIVIND ELIMINAREA MEDICAMENTELOR NEUTILIZATE SAU A MATERIALELOR REZIDUALE PROVENITE DIN ASTFEL DE MEDICAMENTE, DACĂ ESTE CAZUL</td><td>10. ŠPECIÁLNE UPOZORNENIA NA LIKVIDÁCIU NEPOUŽITÝCH LIEKOV ALEBO ODPADOV Z NICH VZNIKNUTÝCH, AK JE TO VHODNÉ</td><td>10. POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI</td><td>10. SÄRSKILDA FÖRSIKTIGHETSÅTGÄRDER FÖR DESTRUKTION AV EJ ANVÄNT LÄKEMEDEL OCH AVFALL I FÖREKOMMANDE FALL</td></tr><tr><td>200000029873</td><td>11. ИМЕ И АДРЕС НА ПРИТЕЖАТЕЛЯ НА РАЗРЕШЕНИЕТО ЗА УПОТРЕБА</td><td>11. NÁZEV A ADRESA DRŽITELE ROZHODNUTÍ O REGISTRACI</td><td>11. NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN</td><td>11. NAME UND ANSCHRIFT DES PHARMAZEUTISCHEN UNTERNEHMERS</td><td>11. ΟΝΟΜΑ ΚΑΙ ΔΙΕΥΘΥΝΣΗ ΚΑΤΟΧΟΥ ΤΗΣ ΑΔΕΙΑΣ ΚΥΚΛΟΦΟΡΙΑΣ</td><td>11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER</td><td>11. NOMBRE Y DIRECCIÓN DEL TITULAR DE LA AUTORIZACIÓN DE COMERCIALIZACIÓN</td><td>11. MÜÜGILOA HOIDJA NIMI JA AADRESS</td><td>11. MYYNTILUVAN HALTIJAN NIMI JA OSOITE</td><td>11. NOM ET ADRESSE DU TITULAIRE DE L’AUTORISATION DE MISE SUR LE MARCHÉ</td><td>11. AINM AGUS SEOLADH SHEALBHÓIR AN ÚDARAITHE MARGAÍOCHTA</td><td>11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET</td><td>11. A FORGALOMBA HOZATALI ENGEDÉLY JOGOSULTJÁNAK NEVE ÉS CÍME</td><td>11. NAFN OG HEIMILISFANG MARKAÐSLEYFISHAFA</td><td>11. NOME E INDIRIZZO DEL TITOLARE DELL’AUTORIZZAZIONE ALL’IMMISSIONE IN COMMERCIO</td><td>11. REGISTRUOTOJO PAVADINIMAS IR ADRESAS</td><td>11. REĢISTRĀCIJAS APLIECĪBAS ĪPAŠNIEKA NOSAUKUMS UN ADRESE</td><td>11. ISEM U INDIRIZZ TAD-DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ</td><td>11. NAAM EN ADRES VAN DE HOUDER VAN DE VERGUNNING VOOR HET IN DE HANDEL BRENGEN</td><td>11. NAVN OG ADRESSE PÅ INNEHAVEREN AV MARKEDSFØRINGSTILLATELSEN</td><td>11. NAZWA I ADRES PODMIOTU ODPOWIEDZIALNEGO</td><td>11. NOME E ENDEREÇO DO TITULAR DA AUTORIZAÇÃO DE INTRODUÇÃO NO MERCADO</td><td>11. NUMELE ȘI ADRESA DEȚINĂTORULUI AUTORIZAȚIEI DE PUNERE PE PIAȚĂ</td><td>11. NÁZOV A ADRESA DRŽITEĽA ROZHODNUTIA O REGISTRÁCII</td><td>11. IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM</td><td>11. INNEHAVARE AV GODKÄNNANDE FÖR FÖRSÄLJNING (NAMN OCH ADRESS)</td></tr><tr><td>200000029874</td><td>12. НОМЕР(А) НА РАЗРЕШЕНИЕТО ЗА УПОТРЕБА</td><td>12. REGISTRAČNÍ ČÍSLO/ČÍSLA</td><td>12. MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE)</td><td>12. ZULASSUNGSNUMMER(N)</td><td>12. ΑΡΙΘΜΟΣ(ΟΙ) ΑΔΕΙΑΣ ΚΥΚΛΟΦΟΡΙΑΣ</td><td>12. MARKETING AUTHORISATION NUMBER(S)</td><td>12. NÚMERO(S) DE AUTORIZACIÓN DE COMERCIALIZACIÓN</td><td>12. MÜÜGILOA NUMBER (NUMBRID)</td><td>12. MYYNTILUVAN NUMERO(T)</td><td>12. NUMÉRO(S) D’AUTORISATION DE MISE SUR LE MARCHÉ</td><td>12. UIMHIR/UIMHREACHA AN ÚDARAITHE MARGAÍOCHTA</td><td>12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET</td><td>12. A FORGALOMBA HOZATALI ENGEDÉLY SZÁMA(I)</td><td>12. MARKAÐSLEYFISNÚMER</td><td>12. NUMERO(I) DELL’AUTORIZZAZIONE ALL’IMMISSIONE IN COMMERCIO</td><td>12. REGISTRACIJOS PAŽYMĖJIMO NUMERIS (-IAI)</td><td>12. REĢISTRĀCIJAS APLIECĪBAS NUMURS(-I)</td><td>12. NUMRU(I) TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ</td><td>12. NUMMER(S) VAN DE VERGUNNING VOOR HET IN DE HANDEL BRENGEN</td><td>12. MARKEDSFØRINGSTILLATELSESNUMMER (NUMRE)</td><td>12. [NUMER POZWOLENIA] [NUMERY POZWOLEŃ] NA DOPUSZCZENIE DO OBROTU</td><td>12. NÚMERO(S) DA AUTORIZAÇÃO DE INTRODUÇÃO NO MERCADO</td><td>12. NUMĂRUL(ELE) AUTORIZAȚIEI DE PUNERE PE PIAȚĂ</td><td>12. REGISTRAČNÉ [ČÍSLO] [ČÍSLA]</td><td>12. ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET</td><td>12. NUMMER PÅ GODKÄNNANDE FÖR FÖRSÄLJNING</td></tr><tr><td>200000029875</td><td>13. ПАРТИДЕН НОМЕР[, КОДОВЕ НА ДАРЕНИЕТО И НА ПРОДУКТА]</td><td>13. ČÍSLO ŠARŽE [, KÓD DÁRCE A KÓD LÉČIVÉHO PŘÍPRAVKU]</td><td>13. BATCHNUMMER [, DONATIONS- OG PRODUKTKODER]</td><td>13. CHARGENBEZEICHNUNG[, SPENDER- UND PRODUKTCODE]</td><td>13. ΑΡΙΘΜΟΣ ΠΑΡΤΙΔΑΣ[, ΣΤΟΙΧΕΙΑ ΔΟΤΗ ΚΑΙ ΚΩΔΙΚΟΙ ΠΡΟΪΟΝΤΟΣ]</td><td>13. BATCH NUMBER[, DONATION AND PRODUCT CODES]</td><td>13. NÚMERO DE LOTE [, CÓDIGO DE DONACIÓN Y DEL PRODUCTO]</td><td>13. PARTII NUMBER [ANNETUSE KOOD(ID) JA TOOTEKOOD(ID)]</td><td>13. ERÄNUMERO [, LUOVUTUS- JA TUOTEKOODIT]</td><td>13. NUMÉRO DU LOT[CODES DON ET PRODUIT]</td><td>13. BAISCUIMHIR[, CÓD DEONAITHE AGUS CÓD TÁIRGE]</td><td>13. BROJ SERIJE[, OZNAKE DONACIJE I PROIZVODA]</td><td>13. A GYÁRTÁSI TÉTEL SZÁMA [DONÁCIÓ ÉS KÉSZÍTMÉNY KÓDJA]</td><td>13. LOTUNÚMER[, AUÐKENNI GJAFAR OG LYFS]</td><td>13. NUMERO DI LOTTO[, CODICI DELLA DONAZIONE E DEL PRODOTTO]</td><td>13. SERIJOS NUMERIS [, DONACIJA IR PREPARATO KODAI]</td><td>13. SĒRIJAS NUMURS[, DĀVINĀJUMA UN ZĀĻU KODS]</td><td>13. NUMRU TAL-LOTT [, DONAZZJONI U KOWD TAL-PRODOTT]</td><td>13. PARTIJNUMMER[, IDENTIFICATIE- EN PRODUCTCODES]</td><td>13. PRODUKSJONSNUMMER[, DONASJONS- OG PRODUKTKODER]</td><td>13. NUMER SERII[, KODY DONACJI I PRODUKTU]</td><td>13. NÚMERO DO LOTE[, CÓDIGOS DA DÁDIVA E DO PRODUTO]</td><td>13. SERIA DE FABRICAȚIE[, CODURILE DONAȚIEI ȘI MEDICAMENTULUI]</td><td>13. ČÍSLO VÝROBNEJ ŠARŽE[, KÓDY ODBERU A LIEKU]</td><td>13. ŠTEVILKA SERIJE[, ENOTNE OZNAKE DAROVANJA IN IZDELKOV]</td><td>13. TILLVERKNINGSSATSNUMMER [, DONATIONS- OCH PRODUKTKODER]</td></tr><tr><td>200000029876</td><td>14. НАЧИН НА ОТПУСКАНЕ</td><td>14. KLASIFIKACE PRO VÝDEJ</td><td>14. GENEREL KLASSIFIKATION FOR UDLEVERING</td><td>14. VERKAUFSABGRENZUNG</td><td>14. ΓΕΝΙΚΗ ΚΑΤΑΤΑΞΗ ΓΙΑ ΤΗ ΔΙΑΘΕΣΗ</td><td>14. GENERAL CLASSIFICATION FOR SUPPLY</td><td>14. CONDICIONES GENERALES DE DISPENSACIÓN</td><td>14. RAVIMI VÄLJASTAMISTINGIMUSED</td><td>14. YLEINEN TOIMITTAMISLUOKITTELU</td><td>14. CONDITIONS DE PRESCRIPTION ET DE DÉLIVRANCE</td><td>14. AICMIÚ GINEARÁLTA LE hAGHAIDH SOLÁTHAIR</td><td>14. NAČIN IZDAVANJA LIJEKA</td><td>14. A GYÓGYSZER ÁLTALÁNOS BESOROLÁSA RENDELHETŐSÉG SZEMPONTJÁBÓL</td><td>14. AFGREIÐSLUTILHÖGUN</td><td>14. CONDIZIONE GENERALE DI FORNITURA</td><td>14. PARDAVIMO (IŠDAVIMO) TVARKA</td><td>14. IZSNIEGŠANAS KĀRTĪBA</td><td>14. KLASSIFIKAZZJONI ĠENERALI TA’ KIF JINGĦATA</td><td>14. ALGEMENE INDELING VOOR DE AFLEVERING</td><td>14. GENERELL KLASSIFIKASJON FOR UTLEVERING</td><td>14. OGÓLNA KATEGORIA DOSTĘPNOŚCI</td><td>14. CLASSIFICAÇÃO QUANTO À DISPENSA AO PÚBLICO</td><td>14. CLASIFICARE GENERALĂ PRIVIND MODUL DE ELIBERARE</td><td>14. ZATRIEDENIE LIEKU PODĽA SPÔSOBU VÝDAJA</td><td>14. NAČIN IZDAJANJA ZDRAVILA</td><td>14. ALLMÄN KLASSIFICERING FÖR FÖRSKRIVNING</td></tr><tr><td>200000029877</td><td>15. УКАЗАНИЯ ЗА УПОТРЕБА</td><td>15. NÁVOD K POUŽITÍ</td><td>15. INSTRUKTIONER VEDRØRENDE ANVENDELSEN</td><td>15. HINWEISE FÜR DEN GEBRAUCH</td><td>15. ΟΔΗΓΙΕΣ ΧΡΗΣΗΣ</td><td>15. INSTRUCTIONS ON USE</td><td>15. INSTRUCCIONES DE USO</td><td>15. KASUTUSJUHEND</td><td>15. KÄYTTÖOHJEET</td><td>15. INDICATIONS D’UTILISATION</td><td>15. TREORACHA ÚSÁIDE</td><td>15. UPUTE ZA UPORABU</td><td>15. AZ ALKALMAZÁSRA VONATKOZÓ UTASÍTÁSOK</td><td>15. NOTKUNARLEIÐBEININGAR</td><td>15. ISTRUZIONI PER L’USO</td><td>15. VARTOJIMO INSTRUKCIJA</td><td>15. NORĀDĪJUMI PAR LIETOŠANU</td><td>15. ISTRUZZJONIJIET DWAR L-UŻU</td><td>15. INSTRUCTIES VOOR GEBRUIK</td><td>15. BRUKSANVISNING</td><td>15. INSTRUKCJA UŻYCIA</td><td>15. INSTRUÇÕES DE UTILIZAÇÃO</td><td>15. INSTRUCȚIUNI DE UTILIZARE</td><td>15. POKYNY NA POUŽITIE</td><td>15. NAVODILA ZA UPORABO</td><td>15. BRUKSANVISNING</td></tr><tr><td>200000029878</td><td>16. ИНФОРМАЦИЯ НА БРАЙЛОВА АЗБУКА</td><td>16. INFORMACE V BRAILLOVĚ PÍSMU</td><td>16. INFORMATION I BRAILLESKRIFT</td><td>16. ANGABEN IN BLINDENSCHRIFT</td><td>16. ΠΛΗΡΟΦΟΡΙΕΣ ΣΕ BRAILLE</td><td>16. INFORMATION IN BRAILLE</td><td>16. INFORMACIÓN EN BRAILLE</td><td>16. TEAVE BRAILLE’ KIRJAS (PUNKTKIRJAS)</td><td>16. TIEDOT PISTEKIRJOITUKSELLA</td><td>16. INFORMATIONS EN BRAILLE</td><td>16. FAISNÉIS IN BRAILLE</td><td>16. PODACI NA BRAILLEOVOM PISMU</td><td>16. BRAILLE ÍRÁSSAL FELTÜNTETETT INFORMÁCIÓK</td><td>16. UPPLÝSINGAR MEÐ BLINDRALETRI</td><td>16. INFORMAZIONI IN BRAILLE</td><td>16. INFORMACIJA BRAILIO RAŠTU</td><td>16. INFORMĀCIJA BRAILA RAKSTĀ</td><td>16. INFORMAZZJONI BIL-BRAILLE</td><td>16. INFORMATIE IN BRAILLE</td><td>16. INFORMASJON PÅ BLINDESKRIFT</td><td>16. INFORMACJA PODANA SYSTEMEM BRAILLE’A</td><td>16. INFORMAÇÃO EM BRAILLE</td><td>16. INFORMAȚII ÎN BRAILLE</td><td>16. INFORMÁCIE V BRAILLOVOM PÍSME</td><td>16. PODATKI V BRAILLOVI PISAVI</td><td>16. INFORMATION I PUNKTSKRIFT</td></tr><tr><td>200000029879</td><td>17. УНИКАЛЕН ИДЕНТИФИКАТОР — ДВУИЗМЕРЕН БАРКОД</td><td>17. JEDINEČNÝ IDENTIFIKÁTOR - 2D ČÁROVÝ KÓD</td><td>17. ENTYDIG IDENTIFIKATOR - 2D-STREGKODE</td><td>17. INDIVIDUELLES ERKENNUNGSMERKMAL - 2D-BARCODE</td><td>17. ΜΟΝΑΔΙΚΟΣ ΑΝΑΓΝΩΡΙΣΤΙΚΟΣ ΚΩΔΙΚΟΣ - ΔΙΣΔΙΑΣΤΑΤΟΣ ΓΡΑΜΜΩΤΟΣ ΚΩΔΙΚΑΣ (2D)</td><td>17. UNIQUE IDENTIFIER - 2D BARCODE</td><td>17. IDENTIFICADOR ÚNICO - CÓDIGO DE BARRAS 2D</td><td>17. AINULAADNE IDENTIFIKAATOR - 2D-vöötkood</td><td>17. YKSILÖLLINEN TUNNISTE - 2D-VIIVAKOODI</td><td>17. IDENTIFIANT UNIQUE - CODE-BARRES 2D</td><td>17. AITHEANTÓIR UATHÚIL - BARRACHÓD 2T</td><td>17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD</td><td>17. EGYEDI AZONOSÍTÓ - 2D VONALKÓD</td><td>17. EINKVÆMT AUÐKENNI - TVÍVÍTT STRIKAMERKI</td><td>17. IDENTIFICATIVO UNICO - CODICE A BARRE BIDIMENSIONALE</td><td>17. UNIKALUS IDENTIFIKATORIUS - 2D BRŪKŠNINIS KODAS</td><td>17. UNIKĀLS IDENTIFIKATORS - 2D SVĪTRKODS</td><td>17. IDENTIFIKATUR UNIKU - BARCODE 2D</td><td>17. UNIEK IDENTIFICATIEKENMERK - 2D MATRIXCODE</td><td>17. SIKKERHETSANORDNING (UNIK IDENTITET) - TODIMENSJONAL STREKKODE</td><td>17. NIEPOWTARZALNY IDENTYFIKATOR - KOD 2D</td><td>17. IDENTIFICADOR ÚNICO - CÓDIGO DE BARRAS 2D</td><td>17. IDENTIFICATOR UNIC - COD DE BARE BIDIMENSIONAL</td><td>17. ŠPECIFICKÝ IDENTIFIKÁTOR - DVOJROZMERNÝ ČIAROVÝ KÓD</td><td>17. EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA</td><td>17. UNIK IDENTITETSBETECKNING – TVÅDIMENSIONELL STRECKKOD</td></tr><tr><td>200000029880</td><td>18. УНИКАЛЕН ИДЕНТИФИКАТОР — ДАННИ ЗА ЧЕТЕНЕ ОТ ХОРА</td><td>18. JEDINEČNÝ IDENTIFIKÁTOR - DATA ČITELNÁ OKEM</td><td>18. ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA</td><td>18. INDIVIDUELLES ERKENNUNGSMERKMAL - VOM MENSCHEN LESBARES FORMAT</td><td>18. ΜΟΝΑΔΙΚΟΣ ΑΝΑΓΝΩΡΙΣΤΙΚΟΣ ΚΩΔΙΚΟΣ - ΔΕΔΟΜΕΝΑ ΑΝΑΓΝΩΣΙΜΑ ΑΠΟ ΤΟΝ ΑΝΘΡΩΠΟ</td><td>18. UNIQUE IDENTIFIER - HUMAN READABLE DATA</td><td>18. IDENTIFICADOR ÚNICO - INFORMACIÓN EN CARACTERES VISUALES</td><td>18. AINULAADNE IDENTIFIKAATOR - INIMLOETAVAD ANDMED</td><td>18. YKSILÖLLINEN TUNNISTE - LUETTAVISSA OLEVAT TIEDOT</td><td>18. IDENTIFIANT UNIQUE - DONNÉES LISIBLES PAR LES HUMAINS</td><td>18. AITHEANTÓIR UATHÚIL - SONRAÍ INLÉITE AG DUINE</td><td>18. JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM</td><td>18. EGYEDI AZONOSÍTÓ OLVASHATÓ FORMÁTUMA</td><td>18. EINKVÆMT AUÐKENNI - UPPLÝSINGAR SEM FÓLK GETUR LESIÐ</td><td>18. IDENTIFICATIVO UNICO - DATI LEGGIBILI</td><td>18. UNIKALUS IDENTIFIKATORIUS - ŽMONĖMS SUPRANTAMI DUOMENYS</td><td>18. UNIKĀLS IDENTIFIKATORS - DATI, KURUS VAR NOLASĪT PERSONA</td><td>18. IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM</td><td>18. UNIEK IDENTIFICATIEKENMERK - VOOR MENSEN LEESBARE GEGEVENS</td><td>18. SIKKERHETSANORDNING (UNIK IDENTITET) - I ET FORMAT LESBART FOR MENNESKER</td><td>18. NIEPOWTARZALNY IDENTYFIKATOR - DANE CZYTELNE DLA CZŁOWIEKA</td><td>18. IDENTIFICADOR ÚNICO - DADOS PARA LEITURA HUMANA</td><td>18. IDENTIFICATOR UNIC - DATE LIZIBILE PENTRU PERSOANE</td><td>18. ŠPECIFICKÝ IDENTIFIKÁTOR - ÚDAJE ČITATEĽNÉ ĽUDSKÝM OKOM</td><td>18. EDINSTVENA OZNAKA - V BERLJIVI OBLIKI</td><td>18. UNIK IDENTITETSBETECKNING - I ETT FORMAT LÄSBART FÖR MÄNSKLIGT ÖGA</td></tr><tr><td>200000029881</td><td>МИНИМУМ ДАННИ, КОИТО ТРЯБВА ДА СЪДЪРЖАТ БЛИСТЕРИТЕ И ЛЕНТИТЕ {ВИД/ТИП}</td><td>MINIMÁLNÍ ÚDAJE UVÁDĚNÉ NA BLISTRECH NEBO STRIPECH {DRUH/TYP}</td><td>MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP {ART/TYPE}</td><td>MINDESTANGABEN AUF BLISTERPACKUNGEN ODER FOLIENSTREIFEN {ART/TYP}</td><td>ΕΛΑΧΙΣΤΕΣ ΕΝΔΕΙΞΕΙΣ ΠΟΥ ΠΡΕΠΕΙ ΝΑ ΑΝΑΓΡΑΦΟΝΤΑΙ ΣΤΙΣ ΣΥΣΚΕΥΑΣΙΕΣ ΚΥΨΕΛΗΣ (BLISTER) Ή ΣΤΙΣ ΤΑΙΝΙΕΣ (STRIPS) {ΜΟΡΦΗ/ΕΙΔΟΣ}</td><td>MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {NATURE/TYPE}</td><td>INFORMACIÓN MÍNIMA A INCLUIR EN BLÍSTERES O TIRAS {NATURALEZA/TIPO}</td><td>MINIMAALSED ANDMED, MIS PEAVAD OLEMA BLISTER- VÕI RIBAPAKENDIL {OLEMUS/TÜÜP}</td><td>LÄPIPAINOPAKKAUKSISSA TAI LEVYISSÄ ON OLTAVA VÄHINTÄÄN SEURAAVAT MERKINNÄT {PAKKAUSTYYPPI}</td><td>MENTIONS MINIMALES DEVANT FIGURER SUR LES PLAQUETTES OU LES FILMS THERMOSOUDÉS {NATURE/TYPE}</td><td>SONRAÍ ÍOSTA LE CUR AR SPUAICPHACAÍ NÓ AR STIALLACHA {CINEÁL}</td><td>PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP {VRSTA/TIP}</td><td>A BUBORÉKCSOMAGOLÁSON VAGY A FÓLIACSÍKON MINIMÁLISAN FELTÜNTETENDŐ ADATOK {A CSOMAGOLÁS TÍPUSA}</td><td>LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á ÞYNNUM EÐA STRIMLUM {GERÐ/TEGUND}</td><td>INFORMAZIONI MINIME DA APPORRE SU BLISTER O STRIP {NATURA/TIPO}</td><td>MINIMALI INFORMACIJA ANT LIZDINIŲ PLOKŠTELIŲ ARBA DVISLUOKSNIŲ JUOSTELIŲ {POBŪDIS/TIPAS}</td><td>MINIMĀLĀ INFORMĀCIJA, KAS JĀNORĀDA UZ BLISTERA VAI PLĀKSNĪTES {VEIDS/TIPS}</td><td>TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL-FOLJI JEW FUQ L-ISTRIXXI {NATURA/TIP}</td><td>GEGEVENS DIE IN IEDER GEVAL OP BLISTERVERPAKKINGEN OF STRIPS MOETEN WORDEN VERMELD {AARD/TYPE}</td><td>MINSTEKRAV TIL OPPLYSNINGER SOM SKAL ANGIS PÅ BLISTER ELLER STRIP {TYPE}</td><td>MINIMUM INFORMACJI ZAMIESZCZANYCH NA BLISTRACH LUB OPAKOWANIACH FOLIOWYCH {RODZAJ OPAKOWANIA}</td><td>INDICAÇÕES MÍNIMAS A INCLUIR NAS EMBALAGENS BLISTER OU FITAS CONTENTORAS {NATUREZA/TIPO}</td><td>MINIMUM DE INFORMAȚII CARE TREBUIE SĂ APARĂ PE BLISTER SAU PE FOLIE TERMOSUDATĂ {NATURA/TIPUL AMBALAJULUI}</td><td>MINIMÁLNE ÚDAJE, KTORÉ MAJÚ BYŤ UVEDENÉ NA BLISTROCH ALEBO STRIPOCH {DRUH/TYP}</td><td>PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU {VRSTA/TIP}</td><td>UPPGIFTER SOM SKA FINNAS PÅ BLISTER ELLER STRIPS {FÖRPACKNINGSTYP}</td></tr><tr><td>200000029882</td><td>1. ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ</td><td>1. NÁZEV LÉČIVÉHO PŘÍPRAVKU</td><td>1. LÆGEMIDLETS NAVN</td><td>1. BEZEICHNUNG DES ARZNEIMITTELS</td><td>1. ΟΝΟΜΑΣΙΑ ΤΟΥ ΦΑΡΜΑΚΕΥΤΙΚΟΥ ΠΡΟΪΟΝΤΟΣ</td><td>1. NAME OF THE MEDICINAL PRODUCT</td><td>1. NOMBRE DEL MEDICAMENTO</td><td>1. RAVIMPREPARAADI NIMETUS</td><td>1. LÄÄKEVALMISTEEN NIMI</td><td>1. DÉNOMINATION DU MÉDICAMENT</td><td>1. AINM AN TÁIRGE ÍOCSHLÁINTE</td><td>1. NAZIV LIJEKA</td><td>1. A GYÓGYSZER NEVE</td><td>1. HEITI LYFS</td><td>1. DENOMINAZIONE DEL MEDICINALE</td><td>1. VAISTINIO PREPARATO PAVADINIMAS</td><td>1. ZĀĻU NOSAUKUMS</td><td>1. ISEM IL-PRODOTT MEDIĊINALI</td><td>1. NAAM VAN HET GENEESMIDDEL</td><td>1. LEGEMIDLETS NAVN</td><td>1. NAZWA PRODUKTU LECZNICZEGO</td><td>1. NOME DO MEDICAMENTO</td><td>1. DENUMIREA COMERCIALĂ A MEDICAMENTULUI</td><td>1. NÁZOV LIEKU</td><td>1. IME ZDRAVILA</td><td>1. LÄKEMEDLETS NAMN</td></tr><tr><td>200000029883</td><td>2. ИМЕ НА ПРИТЕЖАТЕЛЯ НА РАЗРЕШЕНИЕТО ЗА УПОТРЕБА</td><td>2. NÁZEV DRŽITELE ROZHODNUTÍ O REGISTRACI</td><td>2. NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN</td><td>2. NAME DES PHARMAZEUTISCHEN UNTERNEHMERS</td><td>2. ΟΝΟΜΑ ΚΑΤΟΧΟΥ ΤΗΣ ΑΔΕΙΑΣ ΚΥΚΛΟΦΟΡΙΑΣ</td><td>2. NAME OF THE MARKETING AUTHORISATION HOLDER</td><td>2. NOMBRE DEL TITULAR DE LA AUTORIZACIÓN DE COMERCIALIZACIÓN</td><td>2. MÜÜGILOA HOIDJA NIMI</td><td>2. MYYNTILUVAN HALTIJAN NIMI</td><td>2. NOM DU TITULAIRE DE L’AUTORISATION DE MISE SUR LE MARCHÉ</td><td>2. AINM SHEALBHÓIR AN ÚDARAITHE MARGAÍOCHTA</td><td>2. NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET</td><td>2. A FORGALOMBA HOZATALI ENGEDÉLY JOGOSULTJÁNAK NEVE</td><td>2. NAFN MARKAÐSLEYFISHAFA</td><td>2. NOME DEL TITOLARE DELL’AUTORIZZAZIONE ALL’IMMISSIONE IN COMMERCIO</td><td>2. REGISTRUOTOJO PAVADINIMAS</td><td>2. REĢISTRĀCIJAS APLIECĪBAS ĪPAŠNIEKA NOSAUKUMS</td><td>2. ISEM TAD-DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ</td><td>2. NAAM VAN DE HOUDER VAN DE VERGUNNING VOOR HET IN DE HANDEL BRENGEN</td><td>2. NAVN PÅ INNEHAVEREN AV MARKEDSFØRINGSTILLATELSEN</td><td>2. NAZWA PODMIOTU ODPOWIEDZIALNEGO</td><td>2. NOME DO TITULAR DA AUTORIZAÇÃO DE INTRODUÇÃO NO MERCADO</td><td>2. NUMELE DEȚINĂTORULUI AUTORIZAȚIEI DE PUNERE PE PIAȚĂ</td><td>2. NÁZOV DRŽITEĽA ROZHODNUTIA O REGISTRÁCII</td><td>2. IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM</td><td>2. INNEHAVARE AV GODKÄNNANDE FÖR FÖRSÄLJNING</td></tr><tr><td>200000029884</td><td>3. ДАТА НА ИЗТИЧАНЕ НА СРОКА НА ГОДНОСТ</td><td>3. POUŽITELNOST</td><td>3. UDLØBSDATO</td><td>3. VERFALLDATUM</td><td>3. ΗΜΕΡΟΜΗΝΙΑ ΛΗΞΗΣ</td><td>3. EXPIRY DATE</td><td>3. FECHA DE CADUCIDAD</td><td>3. KÕLBLIKKUSAEG</td><td>3. VIIMEINEN KÄYTTÖPÄIVÄMÄÄRÄ</td><td>3. DATE DE PÉREMPTION</td><td>3. DÁTA ÉAGA</td><td>3. ROK VALJANOSTI</td><td>3. LEJÁRATI IDŐ</td><td>3. FYRNINGARDAGSETNING</td><td>3. DATA DI SCADENZA</td><td>3. TINKAMUMO LAIKAS</td><td>3. DERĪGUMA TERMIŅŠ</td><td>3. DATA TA’ SKADENZA</td><td>3. UITERSTE GEBRUIKSDATUM</td><td>3. UTLØPSDATO</td><td>3. TERMIN WAŻNOŚCI</td><td>3. PRAZO DE VALIDADE</td><td>3. DATA DE EXPIRARE</td><td>3. DÁTUM EXSPIRÁCIE</td><td>3. DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA</td><td>3. UTGÅNGSDATUM</td></tr><tr><td>200000029885</td><td>4. ПАРТИДЕН НОМЕР[, КОДОВЕ НА ДАРЕНИЕТО И НА ПРОДУКТА]</td><td>4. ČÍSLO ŠARŽE [, KÓD DÁRCE A KÓD LÉČIVÉHO PŘÍPRAVKU]</td><td>4. BATCHNUMMER[, DONATIONS- OG PRODUKTKODER]</td><td>4. CHARGENBEZEICHNUNG[, SPENDER- UND PRODUKTCODE]</td><td>4. ΑΡΙΘΜΟΣ ΠΑΡΤΙΔΑΣ[, ΣΤΟΙΧΕΙΑ ΔΟΤΗ ΚΑΙ ΚΩΔΙΚΟΙ ΠΡΟΪΟΝΤΟΣ]</td><td>4. BATCH NUMBER[, DONATION AND PRODUCT CODES]</td><td>4. NÚMERO DE LOTE [, CÓDIGO DE DONACIÓN Y DEL PRODUCTO]</td><td>4. PARTII NUMBER [ANNETUSE KOOD(ID) JA TOOTEKOOD(ID)]</td><td>4. ERÄNUMERO [, LUOVUTUS- JA TUOTEKOODIT]</td><td>4. NUMÉRO DU LOT[, CODES DON ET PRODUIT]</td><td>4. BAISCUIMHIR[, CÓD DEONAITHE AGUS CÓD TÁIRGE]</td><td>4. BROJ SERIJE[, OZNAKE DONACIJE I PROIZVODA]</td><td>4. A GYÁRTÁSI TÉTEL SZÁMA [DONÁCIÓ ÉS KÉSZÍTMÉNY KÓDJA]</td><td>4. LOTUNÚMER[, AUÐKENNI GJAFAR OG LYFS]</td><td>4. NUMERO DI LOTTO[, CODICI DELLA DONAZIONE E DEL PRODOTTO]</td><td>4. SERIJOS NUMERIS [, DONACIJA IR PREPARATO KODAI]</td><td>4. SĒRIJAS NUMURS[, DĀVINĀJUMA UN ZĀĻU KODS]</td><td>4. NUMRU TAL-LOTT [, DONAZZJONI U KOWD TAL-PRODOTT]</td><td>4. PARTIJNUMMER[, IDENTIFICATIE- EN PRODUCTCODES]</td><td>4. PRODUKSJONSNUMMER [, DONASJONS- OG PRODUKTKODER]</td><td>4. NUMER SERII[, KODY DONACJI I PRODUKTU]</td><td>4. NÚMERO DO LOTE[, CÓDIGOS DA DÁDIVA E DO PRODUTO]</td><td>4. SERIA DE FABRICAȚIE[, CODURILE DONAȚIEI ȘI MEDICAMENTULUI]</td><td>4. ČÍSLO VÝROBNEJ ŠARŽE[, KÓDY ODBERU A LIEKU]</td><td>4. ŠTEVILKA SERIJE[, ENOTNE OZNAKE DAROVANJA IN IZDELKOV]</td><td>4. TILLVERKNINGSSATSNUMMER [, DONATIONS- OCH PRODUKTKODER]</td></tr><tr><td>200000029886</td><td>5. ДРУГО</td><td>5. JINÉ</td><td>5. ANDET</td><td>5. WEITERE ANGABEN</td><td>5. ΑΛΛΑ ΣΤΟΙΧΕΙΑ</td><td>5. OTHER</td><td>5. OTROS</td><td>5. MUU</td><td>5. MUUTA</td><td>5. AUTRE</td><td>5. EILE</td><td>5. DRUGO</td><td>5. EGYÉB INFORMÁCIÓK</td><td>5. ANNAÐ</td><td>5. ALTRO</td><td>5. KITA</td><td>5. CITA</td><td>5. OĦRAJN</td><td>5. OVERIGE</td><td>5. ANNET</td><td>5. INNE</td><td>5. OUTROS</td><td>5. ALTE INFORMAȚII</td><td>5. INÉ</td><td>5. DRUGI PODATKI</td><td>5. ÖVRIGT</td></tr><tr><td>200000029887</td><td>МИНИМУМ ДАННИ, КОИТО ТРЯБВА ДА СЪДЪРЖАТ МАЛКИТЕ ЕДИНИЧНИ ПЪРВИЧНИ ОПАКОВКИ {ВИД/ТИП}</td><td>MINIMÁLNÍ ÚDAJE UVÁDĚNÉ NA MALÉM VNITŘNÍM OBALU {DRUH/TYP}</td><td>MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER {ART/TYPE}</td><td>MINDESTANGABEN AUF KLEINEN BEHÄLTNISSEN {ART/TYP}</td><td>ΕΛΑΧΙΣΤΕΣ ΕΝΔΕΙΞΕΙΣ ΠΟΥ ΠΡΕΠΕΙ ΝΑ ΑΝΑΓΡΑΦΟΝΤΑΙ ΣΤΙΣ ΜΙΚΡΕΣ ΣΤΟΙΧΕΙΩΔΕΙΣ ΣΥΣΚΕΥΑΣΙΕΣ {ΜΟΡΦΗ/ΕΙΔΟΣ}</td><td>MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {NATURE/TYPE}</td><td>INFORMACIÓN MÍNIMA QUE DEBE INCLUIRSE EN PEQUEÑOS ACONDICIONAMIENTOS PRIMARIOS {NATURALEZA/TIPO}</td><td>MINIMAALSED ANDMED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL {OLEMUS/TÜÜP}</td><td>PIENISSÄ SISÄPAKKAUKSISSA ON OLTAVA VÄHINTÄÄN SEURAAVAT MERKINNÄT {PAKKAUSTYYPPI}</td><td>MENTIONS MINIMALES DEVANT FIGURER SUR LES PETITS CONDITIONNEMENTS PRIMAIRES {NATURE/TYPE}</td><td>SONRAÍ ÍOSTA LE CUR AR AONAID BHEAGA NEASPHACÁISTÍOCHTA {CINEÁL}</td><td>PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE {VRSTA/TIP}</td><td>A KIS KÖZVETLEN CSOMAGOLÁSI EGYSÉGEKEN MINIMÁLISAN FELTÜNTETENDŐ ADATOK {A CSOMAGOLÁS TÍPUSA}</td><td>LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á INNRI UMBÚÐUM LÍTILLA EININGA {GERÐ/TEGUND}</td><td>INFORMAZIONI MINIME DA APPORRE SUI CONFEZIONAMENTI PRIMARI DI PICCOLE DIMENSIONI {NATURA/TIPO}</td><td>MINIMALI INFORMACIJA ANT MAŽŲ VIDINIŲ PAKUOČIŲ {POBŪDIS/TIPAS}</td><td>MINIMĀLĀ INFORMĀCIJA, KAS JĀNORĀDA UZ MAZA IZMĒRA TIEŠĀ IEPAKOJUMA {VEIDS /TIPS}</td><td>TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL-PAKKETTI Ż-ŻGĦAR EWLENIN {NATURA/TIP}</td><td>GEGEVENS DIE IN IEDER GEVAL OP PRIMAIRE KLEINVERPAKKINGEN MOETEN WORDEN VERMELD {AARD/TYPE}</td><td>MINSTEKRAV TIL OPPLYSNINGER SOM SKAL ANGIS PÅ SMÅ INDRE EMBALLASJER {TYPE}</td><td>MINIMUM INFORMACJI ZAMIESZCZANYCH NA MAŁYCH OPAKOWANIACH BEZPOŚREDNICH {RODZAJ OPAKOWANIA}</td><td>INDICAÇÕES MÍNIMAS A INCLUIR EM PEQUENAS UNIDADES DE ACONDICIONAMENTO PRIMÁRIO {NATUREZA/TIPO}</td><td>MINIMUM DE INFORMAȚII CARE TREBUIE SĂ APARĂ PE AMBALAJELE PRIMARE MICI {NATURA/TIPUL AMBALAJULUI}</td><td>MINIMÁLNE ÚDAJE, KTORÉ MAJÚ BYŤ UVEDENÉ NA MALOM VNÚTORNOM OBALE {DRUH/TYP}</td><td>PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH {VRSTA/TIP}</td><td>UPPGIFTER SOM SKA FINNAS PÅ SMÅ INRE LÄKEMEDELSFÖRPACKNINGAR {FÖRPACKNINGSTYP}</td></tr><tr><td>200000029888</td><td>1. ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКT И ПЪТ(ИЩА) НА ВЪВЕЖДАНЕ</td><td>1. NÁZEV LÉČIVÉHO PŘÍPRAVKU A CESTA/CESTY PODÁNÍ</td><td>1. LÆGEMIDLETS NAVN OG ADMINISTRATIONSVEJ(E)</td><td>1. BEZEICHNUNG DES ARZNEIMITTELS SOWIE ART(EN) DER ANWENDUNG</td><td>1. ΟΝΟΜΑΣΙΑ ΤΟΥ ΦΑΡΜΑΚΕΥΤΙΚΟΥ ΠΡΟΪΟΝΤΟΣ ΚΑΙ ΟΔΟΣ(ΟΙ) ΧΟΡΗΓΗΣΗΣ</td><td>1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION</td><td>1. NOMBRE DEL MEDICAMENTO Y VÍA(S) DE ADMINISTRACIÓN</td><td>1. RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D)</td><td>1. LÄÄKEVALMISTEEN NIMI JA TARVITTAESSA ANTOREITTI (ANTOREITIT)</td><td>1. DÉNOMINATION DU MÉDICAMENT ET VOIE(S) D’ADMINISTRATION</td><td>1. AINM AN TÁIRGE ÍOCSHLÁINTE AGUS BEALACH/BEALAÍ TABHARTHA</td><td>1. NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA</td><td>1. A GYÓGYSZER NEVE ÉS AZ ALKALMAZÁS MÓDJA(I)</td><td>1. HEITI LYFS OG ÍKOMULEIÐ(IR)</td><td>1. DENOMINAZIONE DEL MEDICINALE E VIA(E) DI SOMMINISTRAZIONE</td><td>1. VAISTINIO PREPARATO PAVADINIMAS IR VARTOJIMO BŪDAS (-AI)</td><td>1. ZĀĻU NOSAUKUMS UN IEVADĪŠANAS VEIDS(-I)</td><td>1. ISEM TAL-PRODOTT MEDIĊINALI U MNEJN GĦANDU JINGĦATA</td><td>1. NAAM VAN HET GENEESMIDDEL EN DE TOEDIENINGSWEG(EN)</td><td>1. LEGEMIDLETS NAVN OG ADMINISTRASJONSVEI</td><td>1. NAZWA PRODUKTU LECZNICZEGO I [DROGA] [DROGI] PODANIA</td><td>1. NOME DO MEDICAMENTO E VIA(S) DE ADMINISTRAÇÃO</td><td>1. DENUMIREA COMERCIALĂ A MEDICAMENTULUI ȘI CALEA(CĂILE) DE ADMINISTRARE</td><td>1. NÁZOV LIEKU A CESTA (CESTY) PODÁVANIA</td><td>1. IME ZDRAVILA IN POT(I) UPORABE</td><td>1. LÄKEMEDLETS NAMN OCH ADMINISTRERINGSVÄG</td></tr><tr><td>200000029889</td><td>2. НАЧИН НА ПРИЛОЖЕНИЕ</td><td>2. ZPŮSOB PODÁNÍ</td><td>2. ADMINISTRATIONSMETODE</td><td>2. HINWEISE ZUR ANWENDUNG</td><td>2. ΤΡΟΠΟΣ ΧΟΡΗΓΗΣΗΣ</td><td>2. METHOD OF ADMINISTRATION</td><td>2. FORMA DE ADMINISTRACIÓN</td><td>2. MANUSTAMISVIIS</td><td>2. ANTOTAPA</td><td>2. MODE D’ADMINISTRATION</td><td>2. MODH TABHARTHA</td><td>2. NAČIN PRIMJENE LIJEKA</td><td>2. AZ ALKALMAZÁSSAL KAPCSOLATOS TUDNIVALÓK</td><td>2. AÐFERÐ VIÐ LYFJAGJÖF</td><td>2. MODO DI SOMMINISTRAZIONE</td><td>2. VARTOJIMO METODAS</td><td>2. LIETOŠANAS VEIDS</td><td>2. METODU TA’ KIF GĦANDU JINGĦATA</td><td>2. WIJZE VAN TOEDIENING</td><td>2. ADMINISTRASJONSMÅTE</td><td>2. SPOSÓB PODAWANIA</td><td>2. MODO DE ADMINISTRAÇÃO</td><td>2. MODUL DE ADMINISTRARE</td><td>2. SPÔSOB PODÁVANIA</td><td>2. POSTOPEK UPORABE</td><td>2. ADMINISTRERINGSSÄTT</td></tr><tr><td>200000029890</td><td>3. ДАТА НА ИЗТИЧАНЕ НА СРОКА НА ГОДНОСТ</td><td>3. POUŽITELNOST</td><td>3. UDLØBSDATO</td><td>3. VERFALLDATUM</td><td>3. ΗΜΕΡΟΜΗΝΙΑ ΛΗΞΗΣ</td><td>3. EXPIRY DATE</td><td>3. FECHA DE CADUCIDAD</td><td>3. KÕLBLIKKUSAEG</td><td>3. VIIMEINEN KÄYTTÖPÄIVÄMÄÄRÄ</td><td>3. DATE DE PÉREMPTION</td><td>3. DÁTA ÉAGA</td><td>3. ROK VALJANOSTI</td><td>3. LEJÁRATI IDŐ</td><td>3. FYRNINGARDAGSETNING</td><td>3. DATA DI SCADENZA</td><td>3. TINKAMUMO LAIKAS</td><td>3. DERĪGUMA TERMIŅŠ</td><td>3. DATA TA’ SKADENZA</td><td>3. UITERSTE GEBRUIKSDATUM</td><td>3. UTLØPSDATO</td><td>3. TERMIN WAŻNOŚCI</td><td>3. PRAZO DE VALIDADE</td><td>3. DATA DE EXPIRARE</td><td>3. DÁTUM EXSPIRÁCIE</td><td>3. DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA</td><td>3. UTGÅNGSDATUM</td></tr><tr><td>200000029891</td><td>4. ПАРТИДЕН НОМЕР[, КОДОВЕ НА ДАРЕНИЕТО И НА ПРОДУКТА]</td><td>4. ČÍSLO ŠARŽE [, KÓD DÁRCE A KÓD LÉČIVÉHO PŘÍPRAVKU]</td><td>4. BATCHNUMMER[, DONATIONS- OG PRODUKTKODER]</td><td>4. CHARGENBEZEICHNUNG[, SPENDER- UND PRODUKTCODE]</td><td>4. ΑΡΙΘΜΟΣ ΠΑΡΤΙΔΑΣ[, ΣΤΟΙΧΕΙΑ ΔΟΤΗ ΚΑΙ ΚΩΔΙΚΟΙ ΠΡΟΪΟΝΤΟΣ]</td><td>4. BATCH NUMBER[, DONATION AND PRODUCT CODES]</td><td>4. NÚMERO DE LOTE [, CÓDIGO DE DONACIÓN Y DEL PRODUCTO]</td><td>4. PARTII NUMBER [ANNETUSE KOOD(ID) JA TOOTEKOOD(ID)]</td><td>4. ERÄNUMERO [, LUOVUTUS- JA TUOTEKOODIT]</td><td>4. NUMÉRO DU LOT[, CODES DON ET PRODUIT]</td><td>4. BAISCUIMHIR[, CÓD DEONAITHE AGUS CÓD TÁIRGE]</td><td>4. BROJ SERIJE[, OZNAKE DONACIJE I PROIZVODA]</td><td>4. A GYÁRTÁSI TÉTEL SZÁMA [DONÁCIÓ ÉS KÉSZÍTMÉNY KÓDJA]</td><td>4. LOTUNÚMER[, AUÐKENNI GJAFAR OG LYFS]</td><td>4. NUMERO DI LOTTO[, CODICI DELLA DONAZIONE E DEL PRODOTTO]</td><td>4. SERIJOS NUMERIS [, DONACIJA IR PREPARATO KODAI]</td><td>4. SĒRIJAS NUMURS[, DĀVINĀJUMA UN ZĀĻU KODS]</td><td>4. NUMRU TAL-LOTT [, DONAZZJONI U KOWD TAL-PRODOTT]</td><td>4. PARTIJNUMMER[, IDENTIFICATIE- EN PRODUCTCODES]</td><td>4. PRODUKSJONSNUMMER[, DONASJONS- OG PRODUKTKODER]</td><td>4. NUMER SERII[, KODY DONACJI I PRODUKTU]</td><td>4. NÚMERO DO LOTE[, CÓDIGOS DA DÁDIVA E DO PRODUTO]</td><td>4. SERIA DE FABRICAȚIE[, CODURILE DONAȚIEI ȘI MEDICAMENTULUI]</td><td>4. ČÍSLO VÝROBNEJ ŠARŽE[, KÓDY ODBERU A LIEKU]</td><td>4. ŠTEVILKA SERIJE[, ENOTNE OZNAKE DAROVANJA IN IZDELKOV]</td><td>4. TILLVERKNINGSSATSNUMMER [, DONATIONS- OCH PRODUKTKODER]</td></tr><tr><td>200000029892</td><td>5. СЪДЪРЖАНИЕ КАТО МАСА, ОБЕМ ИЛИ ЕДИНИЦИ</td><td>5. OBSAH UDANÝ JAKO HMOTNOST, OBJEM NEBO POČET</td><td>5. INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ENHEDER</td><td>5. INHALT NACH GEWICHT, VOLUMEN ODER EINHEITEN</td><td>5. ΠΕΡΙΕΧΟΜΕΝΟ ΚΑΤΑ ΒΑΡΟΣ, ΚΑΤ' ΟΓΚΟ Ή ΚΑΤΑ ΜΟΝΑΔΑ</td><td>5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT</td><td>5. CONTENIDO EN PESO, EN VOLUMEN O EN UNIDADES</td><td>5. PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI</td><td>5. SISÄLLÖN MÄÄRÄ PAINONA, TILAVUUTENA TAI YKSIKKÖINÄ</td><td>5. CONTENU EN POIDS, VOLUME OU UNITÉ</td><td>5. INNEACHAR DE RÉIR MEÁCHAIN, DE RÉIR TOIRTE NÓ DE RÉIR AONAID</td><td>5. SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA</td><td>5. A TARTALOM TÖMEGRE, TÉRFOGATRA, VAGY EGYSÉGRE VONATKOZTATVA</td><td>5. INNIHALD TILGREINT SEM ÞYNGD, RÚMMÁL EÐA FJÖLDI EININGA</td><td>5. CONTENUTO IN PESO, VOLUME O UNITÀ</td><td>5. KIEKIS (MASĖ, TŪRIS ARBA VIENETAI)</td><td>5. SATURA SVARS, TILPUMS VAI VIENĪBU DAUDZUMS</td><td>5. IL-KONTENUT SKONT IL-PIŻ, IL-VOLUM, JEW PARTI INDIVIDWALI</td><td>5. INHOUD UITGEDRUKT IN GEWICHT, VOLUME OF EENHEID</td><td>5. INNHOLD ANGITT ETTER VEKT, VOLUM ELLER ANTALL DOSER</td><td>5. ZAWARTOŚĆ OPAKOWANIA Z PODANIEM MASY, OBJĘTOŚCI LUB LICZBY JEDNOSTEK</td><td>5. CONTEÚDO EM PESO, VOLUME OU UNIDADE</td><td>5. CONȚINUTUL PE MASĂ, VOLUM SAU UNITATEA DE DOZĂ</td><td>5. OBSAH V HMOTNOSTNÝCH, OBJEMOVÝCH ALEBO KUSOVÝCH JEDNOTKÁCH</td><td>5. VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT</td><td>5. MÄNGD UTTRYCKT I VIKT, VOLYM ELLER PER ENHET</td></tr><tr><td>200000029893</td><td>6. ДРУГО</td><td>6. JINÉ</td><td>6. ANDET</td><td>6. WEITERE ANGABEN</td><td>6. ΑΛΛΑ ΣΤΟΙΧΕΙΑ</td><td>6. OTHER</td><td>6. OTROS</td><td>6. MUU</td><td>6. MUUTA</td><td>6. AUTRE</td><td>6. EILE</td><td>6. DRUGO</td><td>6. EGYÉB INFORMÁCIÓK</td><td>6. ANNAÐ</td><td>6. ALTRO</td><td>6. KITA</td><td>6. CITA</td><td>6. OĦRAJN</td><td>6. OVERIGE</td><td>6. ANNET</td><td>6. INNE</td><td>6. OUTROS</td><td>6. ALTE INFORMAȚII</td><td>6. INÉ</td><td>6. DRUGI PODATKI</td><td>6. ÖVRIGT</td></tr><tr><td>200000029894</td><td>ЛИСТОВКА</td><td>PŘÍBALOVÁ INFORMACE</td><td>INDLÆGSSEDDEL</td><td>PACKUNGSBEILAGE</td><td>ΦΥΛΛΟ ΟΔΗΓΙΩΝ ΧΡΗΣΗΣ</td><td>PACKAGE LEAFLET</td><td>PROSPECTO</td><td>PAKENDI INFOLEHT</td><td>PAKKAUSSELOSTE</td><td>NOTICE</td><td>BILEOG PHACÁISTE</td><td>UPUTA O LIJEKU</td><td>BETEGTÁJÉKOZTATÓ</td><td>FYLGISEÐILL</td><td>FOGLIO ILLUSTRATIVO</td><td>PAKUOTĖS LAPELIS</td><td>LIETOŠANAS INSTRUKCIJA</td><td>FULJETT TA’ TAGĦRIF</td><td>BIJSLUITER</td><td>PAKNINGSVEDLEGG</td><td>ULOTKA DLA PACJENTA</td><td>FOLHETO INFORMATIVO</td><td>PROSPECTUL</td><td>PÍSOMNÁ INFORMÁCIA PRE POUŽÍVATEĽA</td><td>NAVODILO ZA UPORABO</td><td>BIPACKSEDEL</td></tr><tr><td>200000029895</td><td>1. Какво представлява Х и за какво се използва</td><td>1. Co je [přípravek] X a k čemu se používá</td><td>1. Virkning og anvendelse</td><td>1. Was ist X und wofür wird es angewendet?</td><td>1. Τι είναι το Χ και ποια είναι η χρήση του</td><td>1. What X is and what it is used for</td><td>1. Qué es X y para qué se utiliza</td><td>1. Mis ravim on X ja milleks seda kasutatakse</td><td>1. Mitä X on ja mihin sitä käytetään</td><td>1. Qu’est-ce que X et dans quels cas est-il utilisé</td><td>1. Cad é X agus cén úsáid a bhaintear as</td><td>1. Što je X i za što se koristi</td><td>1. Milyen típusú gyógyszer a(z) X és milyen betegségek esetén alkalmazható?</td><td>1. Upplýsingar um X og við hverju það er notað</td><td>1. Cos’è X e a cosa serve</td><td>1. Kas yra X ir kam jis vartojamas</td><td>1. Kas ir X un kādam nolūkam tās/to lieto</td><td>1. X’inhu X u gћalxiex jintuża</td><td>1. Wat is X en waarvoor wordt dit middel [gebruikt][ingenomen]?</td><td>1. Hva X er og hva det brukes mot</td><td>1. Co to jest [lek] X i w jakim celu się go stosuje</td><td>1. O que é X e para que é utilizado</td><td>1. Ce este X și pentru ce se utilizează</td><td>1. Čo je X a na čo sa používa</td><td>1. Kaj je zdravilo X in za kaj ga uporabljamo</td><td>1. Vad X är och vad det används för</td></tr><tr><td>200000029896</td><td>2. Какво трябва да знаете, преди да [приемете] [използвате] Х</td><td>2. Čemu musíte věnovat pozornost, než začnete [přípravek] X [užívat] [používat]</td><td>2. Det skal [De] [du] vide, før [De] [du] begynder at [tage] [bruge] [få] {X}</td><td>2. Was sollten Sie vor der [Einnahme] [Anwendung] von X beachten?</td><td>2. Τι πρέπει να γνωρίζετε πριν [πάρετε] [χρησιμοποιήσετε] το Χ</td><td>2. What you need to know before you [take] [use] X</td><td>2. Qué necesita saber antes de empezar a [tomar][usar] X</td><td>2. Mida on vaja teada enne X’i [võtmist] [kasutamist]</td><td>2. Mitä sinun on tiedettävä, ennen kuin [otat] [käytät] [X:ää] [X-valmistetta]</td><td>2. Quelles sont les informations à connaître avant [de prendre] [d’utiliser] X</td><td>2. An t-eolas a theastaíonn uait sula [dtóga] [n-úsáide] tú X.</td><td>2. Što morate znati prije nego počnete [uzimati] [primjenjivati] X</td><td>2. Tudnivalók a(z) X [szedése][alkalmazása] előtt</td><td>2. Áður en byrjað er að nota X</td><td>2. Cosa deve sapere prima di [prendere] [usare] X</td><td>2. Kas žinotina prieš vartojant X</td><td>2. Kas Jums jāzina pirms X lietošanas</td><td>2. X'għandek tkun taf qabel ma [tieħu] [tuża] X</td><td>2. Wanneer mag u dit middel niet [gebruiken][innemen] of moet u er extra voorzichtig mee zijn?</td><td>2. Hva du må vite før du bruker X</td><td>2. Informacje ważne przed [przyjęciem] [zastosowaniem] [leku] X</td><td>2. O que precisa de saber antes de [tomar] [utilizar] X</td><td>2. Ce trebuie să știți înainte să [luați][utilizați] X</td><td>2. Čo potrebujete vedieť predtým, ako [užijete] [použijete] X</td><td>2. Kaj morate vedeti, preden [boste vzeli] [boste uporabili] zdravilo X</td><td>2. Vad du behöver veta innan du [tar] [använder] X</td></tr><tr><td>200000029897</td><td>Не [приемайте] [използвайте] X</td><td>[Neužívejte] [Nepoužívejte] [přípravek] X</td><td>[Tag] [Brug] [få] ikke {X}</td><td>X darf nicht [eingenommen] [angewendet] werden[,]</td><td>Μην [πάρετε] [χρησιμοποιήσετε] το Χ</td><td>Do not [take] [use] X</td><td>No [tome][use] X</td><td>X’i ei tohi [võtta] [kasutada]</td><td>Älä [ota] [käytä] [X:ää] [X-valmistetta]</td><td>[Ne prenez] [N’utilisez] jamais X</td><td>Ná [tóg] [húsáid] X.</td><td>Nemojte [uzimati] [primjenjivati] X</td><td>Ne [szedje][alkalmazza] a(z) X-et[:]</td><td>Ekki má nota X</td><td>Non [prenda] [usi] X</td><td>X vartoti draudžiama</td><td>Nelietojiet X šādos gadījumos[:]</td><td>[Tiħux] [Tużax] X[:]</td><td>Wanneer mag u dit middel niet gebruiken?</td><td>Bruk ikke X[:]</td><td>Kiedy nie [przyjmować] [stosować] [leku] X</td><td>Não [tome] [utilize] X</td><td>Nu [luați][utilizați] X</td><td>[Neužívajte] [Nepoužívajte] X</td><td>Ne [jemljite] [uporabljajte] zdravila X</td><td>[Ta] [Använd] inte X[:]</td></tr><tr><td>200000029898</td><td>Предупреждения и предпазни мерки</td><td>Upozornění a opatření</td><td>Advarsler og forsigtighedsregler</td><td>Warnhinweise und Vorsichtsmaßnahmen</td><td>Προειδοποιήσεις και προφυλάξεις</td><td>Warnings and precautions</td><td>Advertencias y precauciones</td><td>Hoiatused ja ettevaatusabinõud</td><td>Varoitukset ja varotoimet</td><td>Avertissements et précautions</td><td>Rabhaidh agus réamhchúraimí</td><td>Upozorenja i mjere opreza</td><td>Figyelmeztetések és óvintézkedések</td><td>Varnaðarorð og varúðarreglur</td><td>Avvertenze e precauzioni</td><td>Įspėjimai ir atsargumo priemonės</td><td>Brīdinājumi un piesardzība lietošanā</td><td>Twissijiet u prekawzjonijiet</td><td>Wanneer moet u extra voorzichtig zijn met dit middel?</td><td>Advarsler og forsiktighetsregler</td><td>Ostrzeżenia i środki ostrożności</td><td>Advertências e precauções</td><td>Atenționări și precauții</td><td>Upozornenia a opatrenia</td><td>Opozorila in previdnostni ukrepi</td><td>Varningar och försiktighet</td></tr><tr><td>200000029899</td><td>Деца [и юноши]</td><td>Děti [a dospívající]</td><td>Børn [og unge]</td><td>Kinder [und Jugendliche]</td><td>Παιδιά [και έφηβοι]</td><td>Children [and adolescents]</td><td>Niños [y adolescentes]</td><td>Lapsed [ja noorukid]</td><td>Lapset [ja nuoret]</td><td>Enfants [et adolescents]</td><td>Leanaí [agus ógánaigh]</td><td>Djeca [i adolescenti]</td><td>Gyermekek [és serdülők]</td><td>Börn [og unglingar]</td><td>Bambini [e adolescenti]</td><td>Vaikams [ir paaugliams]</td><td>Bērni un [pusaudži]</td><td>Tfal [u adolexxenti]</td><td>Kinderen [en jongeren tot 18 jaar]</td><td>Barn [og ungdom]</td><td>Dzieci [i młodzież]</td><td>Crianças [e adolescentes]</td><td>Copii [și adolescenți]</td><td>Deti [a dospievajúci]</td><td>Otroci [in mladostniki]</td><td>Barn [och ungdomar]</td></tr><tr><td>200000029900</td><td>Други лекарства и Х</td><td>Další léčivé přípravky a [přípravek] X</td><td>Brug af andre lægemidler sammen med {X}</td><td>[Einnahme] [Anwendung] von X zusammen mit anderen Arzneimitteln</td><td>Άλλα φάρμακα και Χ</td><td>Other medicines and X</td><td>Otros medicamentos y X</td><td>Muud ravimid ja X</td><td>Muut lääkevalmisteet ja X</td><td>Autres médicaments et X</td><td>Cógais eile agus X</td><td>Drugi lijekovi i X</td><td>Egyéb gyógyszerek és a(z) X</td><td>Notkun annarra lyfja samhliða X</td><td>Altri medicinali e X</td><td>Kiti vaistai ir X</td><td>Citas zāles un X</td><td>Mediċini oħra u X</td><td>[Gebruikt u nog andere geneesmiddelen?][Neemt u nog andere geneesmiddelen in?]</td><td>Andre legemidler og X</td><td>[Lek] X a inne leki</td><td>Outros medicamentos e X</td><td>X împreună cu alte medicamente</td><td>Iné lieky a X</td><td>Druga zdravila in zdravilo X</td><td>Andra läkemedel och X</td></tr><tr><td>200000029901</td><td>X с [храна] [и] [,] [напитки] [и] [алкохол]</td><td>[Přípravek] X s [jídlem] [a] [,] [pitím] [a] [alkoholem]</td><td>Brug af {X} sammen med [mad] [og] [,] [drikke] [og] [alkohol]</td><td>[Einnahme] [Anwendung] von X zusammen mit [Nahrungsmitteln] [und] [,] [Getränken] [und] [Alkohol]</td><td>Το Χ με [τροφή] [και] [,] [ποτό] [και] [οινοπνευματώδη]</td><td>X with [food] [and] [,] [drink] [and] [alcohol]</td><td>[Uso][Toma] de X con [alimentos][y][,][bebidas][y][alcohol]</td><td>X koos [toidu] [ja] [,] [joogi] [ja] [alkoholiga]</td><td>X [ruuan] [ja] [,] [juoman] [ja] [alkoholin] kanssa</td><td>X avec [des aliments] [et] [,] [boissons] [et] [de l’alcool]</td><td>X in éineacht le [bia] [agus] [,] [deoch] [agus] [alcól]</td><td>X s [hranom] [i] [,] [pićem] [i] [alkoholom]</td><td>[Az étel] [és] [,] [az ital] [és] az alkohol hatása a(z) X-re</td><td>Notkun X með [mat] [eða] [,] [drykk] [eða] [áfengi]</td><td>X con [cibo] [e] [,] [bevande] [e] [alcol]</td><td>X vartojimas su [maistu] [ir] [,] [gėrimais] [ir] [alkoholiu]</td><td>X kopā ar [uzturu] [un] [,] [dzērienu] [un] [alkoholu]</td><td>X ma’ [ikel][u] [,] [xorb] [u] [alkoħol]</td><td>Waarop moet u letten met [eten] [en] [,] [drinken] [en] [alcohol]?</td><td>Inntak av X sammen med [mat] [og] [,] [drikke] [og] [alkohol]</td><td>Stosowanie leku X z [jedzeniem] [i] [,] [piciem] [i] [alkoholem]</td><td>X com [alimentos] [e] [,] [bebidas] [e] [álcool]</td><td>X împreună cu [alimente][și][,][băuturi][și][alcool]</td><td>X a [jedlo] [a] [,] [nápoje][a][alkohol]</td><td>Zdravilo X skupaj [s][z] [hrano] [in] [,] [pijačo] [in] [alkoholom]</td><td>X med [mat] [och ] [,] [dryck] [och] [alkohol]</td></tr><tr><td>200000029902</td><td>Бременност [и] [,] кърмене [и фертилитет]</td><td>Těhotenství [a] [,] kojení [a plodnost]</td><td>Graviditet [og] [,] amning [og frugtbarhed]</td><td>Schwangerschaft [und] [,] Stillzeit [und Fortpflanzungsfähigkeit]</td><td>Κύηση[,] [και] θηλασμός [και γονιμότητα]</td><td>Pregnancy [and] [,] breast-feeding [and fertility]</td><td>Embarazo [y][,] lactancia [y fertilidad]</td><td>Rasedus [ja] [,] imetamine [ja viljakus]</td><td>Raskaus [ja] [,] imetys [ja hedelmällisyys]</td><td>Grossesse [et] [,] allaitement [et fertilité]</td><td>Toircheas [agus] [,] beathú cíche [agus torthúlacht]</td><td>Trudnoća [i] [,] dojenje [i plodnost]</td><td>Terhesség [és][,] szoptatás [ és termékenység]</td><td>Meðganga [og] [,] brjóstagjöf [og frjósemi]</td><td>Gravidanza [e] [,] allattamento [e fertilità]</td><td>Nėštumas [ir] [,] žindymo laikotarpis [ir vaisingumas]</td><td>Grūtniecība [un] [,] barošana ar krūti [un fertilitāte]</td><td>Tqala [u] [,] treddigħ [u fertilità]</td><td>Zwangerschap [en] [,] borstvoeding [en vruchtbaarheid]</td><td>Graviditet [og] [,] amming [og fertilitet]</td><td>Ciąża [i] [,] karmienie piersią [i wpływ na płodność]</td><td>Gravidez [e] [,] amamentação [e fertilidade]</td><td>Sarcina [și][,] alăptarea [și fertilitatea]</td><td>Tehotenstvo [a] [dojčenie] [a plodnosť]</td><td>Nosečnost [in] [,] dojenje [in plodnost]</td><td>Graviditet [och] [,] amning [och fertilitet]</td></tr><tr><td>200000029903</td><td>Шофиране и работа с машини</td><td>Řízení dopravních prostředků a obsluha strojů</td><td>Trafik- og arbejdssikkerhed</td><td>Verkehrstüchtigkeit und Fähigkeit zum Bedienen von Maschinen</td><td>Οδήγηση και χειρισμός μηχανημάτων</td><td>Driving and using machines</td><td>Conducción y uso de máquinas</td><td>Autojuhtimine ja masinatega töötamine</td><td>Ajaminen ja koneiden käyttö</td><td>Conduite de véhicules et utilisation de machines</td><td>Tiomáint agus meaisíní a úsáid</td><td>Upravljanje vozilima i strojevima</td><td>A készítmény hatásai a gépjárművezetéshez és a gépek kezeléséhez szükséges képességekre</td><td>Akstur og notkun véla</td><td>Guida di veicoli e utilizzo di macchinari</td><td>Vairavimas ir mechanizmų valdymas</td><td>Transportlīdzekļu vadīšana un mehānismu apkalpošana</td><td>Sewqan u tħaddim ta’ magni</td><td>Rijvaardigheid en het gebruik van machines</td><td>Kjøring og bruk av maskiner</td><td>Prowadzenie pojazdów i obsługiwanie maszyn</td><td>Condução de veículos e utilização de máquinas</td><td>Conducerea vehiculelor și folosirea utilajelor</td><td>Vedenie vozidiel a obsluha strojov</td><td>Vpliv na sposobnost upravljanja vozil in strojev</td><td>Körförmåga och användning av maskiner</td></tr><tr><td>200000029904</td><td>X съдържа {име на помощното(ите) вещество(а)}</td><td>Přípravek] X obsahuje {název pomocné látky/pomocných látek}</td><td>{X} indeholder {nævn de(t) hjælpestof(fer), hvor advarsel er påkrævet}</td><td>X enthält {Bezeichnung [des] [der] sonstigen Bestandteil(s)(e)}</td><td>Το Χ περιέχει {όνομα(τα) εκδόχου(ων)}</td><td>X contains {name the excipient(s)}</td><td>X contiene {nombre del (de los) excipiente(s)}</td><td>X sisaldab {abiaine(te) nimetus}</td><td>X sisältää {apuaineen(apuaineiden) nimi(nimet)}</td><td>X contient {nommer le/les excipient(s)}</td><td>Tá {ainm an támháin/na dtámhán} in X</td><td>X sadrži {naziv pomoćne(ih) tvari}</td><td>A(z) X {segédanyag(ok) neve}-t tartalmaz</td><td>X inniheldur {tilgreinið viðkomandi hjálparefni}</td><td>X contiene {nome del(degli) eccipiente(i)}</td><td>X sudėtyje yra {pagalbinės (-ių) medžiagos (-ų) pavadinimas (-ai)}</td><td>X satur {palīgvielas(-u) nosaukums(-i)}</td><td>X fih {isem tas-sustanza(i) mhux attiva(i)}</td><td>X bevat {naam van de hulpstof(fen)}</td><td>X inneholder {navn på hjelpestoff(er)}</td><td>[Lek] X zawiera {[nazwa substancji pomocniczej] [nazwy substancji pomocniczych]}</td><td>X contém {nome do(s) excipiente(s)}</td><td>X conține {numele excipientului(ților)}</td><td>X obsahuje {názov pomocnej látky(pomocných látok)}</td><td>Zdravilo X vsebuje {ime pomožne(ih) snovi}</td><td>X innehåller {namn på hjälpämne(n)}</td></tr><tr><td>200000029905</td><td>3. Как да [приемате] [използвате] Х</td><td>3. Jak se [přípravek] X [užívá] [používá]</td><td>3. Sådan skal [De] [du] [tage] [bruge] {X} / Sådan får [De] [du] {X}</td><td>3. Wie ist X [einzunehmen] [anzuwenden]?</td><td>3. Πώς να [πάρετε] [χρησιμοποιήσετε] το Χ</td><td>3. How to [take] [use] X</td><td>3. Cómo [tomar][usar] X</td><td>3. Kuidas X’i [võtta] [kasutada]</td><td>3. Miten [X:ää] [X-valmistetta] [otetaan] [käytetään]</td><td>3. Comment [prendre] [utiliser] X</td><td>3. Conas X a [thógáil] [úsáid].</td><td>3. Kako [uzimati] [primjenjivati] X</td><td>3. Hogyan kell [szedni][alkalmazni] a(z) X-et?</td><td>3. Hvernig nota á X</td><td>3. Come [prendere] [usare] X</td><td>3. Kaip vartoti X</td><td>3. Kā lietot X</td><td>3. Kif gћandek [tieћu][tuża] X</td><td>3. Hoe [gebruikt u dit middel][neemt u dit middel in]?</td><td>3. Hvordan du bruker X</td><td>3. Jak [przyjmować] [stosować] [lek] X</td><td>3. Como [tomar] [utilizar] X</td><td>3. Cum să [luați][utilizați] X</td><td>3. Ako [užívať] [používať] X</td><td>3. Kako [jemati] [uporabljati] zdravilo X</td><td>3. Hur du [tar] [använder] X</td></tr><tr><td>200000029906</td><td>Употреба при деца [и юноши]</td><td>Použití u dětí [a dospívajících]</td><td>Brug til børn [og unge]</td><td>Anwendung bei Kindern [und Jugendlichen]</td><td>Χρήση σε παιδιά] [και εφήβους]</td><td>Use in children [and adolescents]</td><td>Uso en niños [y adolescentes]</td><td>Kasutamine lastel [ja noorukitel]</td><td>Käyttö lapsille [ja nuorille]</td><td>Utilisation chez les enfants [et les adolescents]</td><td>Úsáid le leanaí [agus le hógánaigh]</td><td>Primjena u djece [i adolescenata]</td><td>Alkalmazása gyermekeknél [és serdülőknél]</td><td>Notkun handa börnum [og unglingum]</td><td>Uso nei bambini [e negli adolescenti]</td><td>Vartojimas vaikams [ir paaugliams]</td><td>Lietošana bērniem [un pusaudžiem]</td><td>Użu fit-tfal [u fl-adolexxenti]</td><td>Gebruik bij kinderen [en jongeren tot 18 jaar]</td><td>Bruk hos barn [og ungdom]</td><td>Stosowanie u dzieci [i młodzieży]</td><td>Utilização em crianças [e adolescentes]</td><td>Utilizarea la copii [și adolescenți]</td><td>Použitie u detí [a dospievajúcich]</td><td>Uporaba pri otrocih [in mladostnikih]</td><td>Användning för barn [och ungdomar]</td></tr><tr><td>200000029907</td><td>Ако сте [приели] [използвали] повече от необходимата доза X</td><td>Jestliže jste [užil(a)] [použil(a)] více [přípravku]X, než jste měl(a)</td><td>Hvis [De] [du] har [taget] [brugt] [fået] for meget {X}</td><td>Wenn Sie eine größere Menge von X [eingenommen] [angewendet] haben, als Sie sollten</td><td>Εάν [πάρετε] [χρησιμοποιήσετε] μεγαλύτερη δόση Χ από την κανονική</td><td>If you [take] [use] more X than you should</td><td>Si [toma][usa] más X del que debe</td><td>Kui te [võtate] [kasutate] X’i rohkem, kui ette nähtud</td><td>Jos [otat] [käytät] enemmän [X:ää] [X-valmistetta] kuin sinun pitäisi</td><td>Si vous avez [pris] [utilisé] plus de X que vous n’auriez dû</td><td>Má [thóg] [d’úsáid] tú níos mó X ná mar ba chóir duit</td><td>Ako [uzmete] [primijenite] više X nego što ste trebali</td><td>Ha az előírtnál több X-et [vett be][alkalmazott]</td><td>Ef [tekinn] [notaður] er stærri skammtur en mælt er fyrir um</td><td>Se [prende] [usa] più X di quanto deve</td><td>Ką daryti pavartojus per didelę X dozę?</td><td>Ja esat lietojis X vairāk nekā noteikts</td><td>Jekk [tieħu] [tuża] X aktar milli suppost</td><td>Heeft u te veel van dit middel [gebruikt] [ingenomen]?</td><td>Dersom du tar for mye av X</td><td>[Przyjęcie] [Zastosowanie] większej niż zalecana dawki [leku] X</td><td>Se [tomar] [utilizar] mais X do que deveria</td><td>Dacă [luați][utilizați] mai mult X decât trebuie</td><td>Ak [užijete] [použijete] viac X, ako máte</td><td>Če ste [vzeli] [uporabili] večji odmerek zdravila X, kot bi smeli</td><td>Om du [har tagit] [använt] för stor mängd av X</td></tr><tr><td>200000029908</td><td>Ако сте пропуснали да [приемете] [използвате] X</td><td>Jestliže jste zapomněl(a) [užít] [použít] [přípravek]X</td><td>Hvis [De] [du] har glemt at [tage] [bruge] [få] {X}</td><td>Wenn Sie die [Einnahme] [Anwendung] von X vergessen haben</td><td>Εάν ξεχάσετε να [πάρετε] [χρησιμοποιήσετε] το Χ</td><td>If you forget to [take] [use] X</td><td>Si olvidó [tomar][usar] X</td><td>Kui te unustate X’i [võtta] [kasutada]</td><td>Jos unohdat [ottaa] [käyttää] [X:ää] [X-valmistetta]</td><td>Si vous oubliez [de prendre] [d’utiliser] X</td><td>Má dhéanann tú dearmad X a [thógáil] [úsáid]</td><td>Ako ste zaboravili [uzeti] [primijeniti] X</td><td>Ha elfelejtette [bevenni][alkalmazni] a(z) X-et</td><td>Ef gleymist að [taka] [nota] X</td><td>Se dimentica di [prendere] [usare] X</td><td>Pamiršus pavartoti X</td><td>Ja esat aizmirsis lietot X</td><td>Jekk tinsa [tieħu] [tuża] X</td><td>Bent u vergeten dit middel [te gebruiken] [in te nemen]?</td><td>Dersom du har glemt å ta X</td><td>Pominięcie [przyjęcia] [zastosowania] [leku] X</td><td>Caso se tenha esquecido de [tomar] [utilizar] X</td><td>Dacă uitați să [luați][utilizați] X</td><td>Ak zabudnete [užiť] [použiť] X</td><td>Če ste pozabili [vzeti] [uporabiti] zdravilo X</td><td>Om du har glömt att [ta] [använda] X</td></tr><tr><td>200000029909</td><td>Ако сте спрели [приема] [употребата] на X</td><td>Jestliže jste přestal(a) [užívat] [používat] [přípravek]X</td><td>Hvis [De] [du] holder op med at [tage] [bruge] [få] {X}</td><td>Wenn Sie die [Einnahme] [Anwendung] von X abbrechen</td><td>Εάν σταματήσετε να [παίρνετε] [χρησιμοποιείτε] το Χ</td><td>If you stop [taking] [using] X</td><td>Si interrumpe el tratamiento con X</td><td>Kui te lõpetate X’i [võtmise] [kasutamise]</td><td>Jos lopetat [X:n] [X-valmisteen] [oton] [käytön]</td><td>Si vous arrêtez [de prendre] [d’utiliser] X</td><td>Má stopann tú de X a [thógáil] [úsáid]</td><td>Ako prestanete [uzimati] [primjenjivati] X</td><td>Ha idő előtt abbahagyja a(z) X [szedését][alkalmazását]</td><td>Ef hætt er að nota X</td><td>Se interrompe il trattamento con X</td><td>Nustojus vartoti X</td><td>Ja pārtraucat lietot X</td><td>Jekk tieqaf [tieħu] [tuża] X</td><td>Als u stopt met het [innemen] [gebruik] van dit middel</td><td>Dersom du avbryter behandling med X</td><td>Przerwanie [przyjmowania] [stosowania] [leku] X</td><td>Se parar de [tomar] [utilizar] X</td><td>Dacă încetați să [luați][utilizați] X</td><td>Ak prestanete [užívať] [používať] X</td><td>Če ste prenehali [jemati] [uporabljati] zdravilo X</td><td>Om du slutar att [ta] [använda]X</td></tr><tr><td>200000029910</td><td>4. Възможни нежелани реакции</td><td>4. Možné nežádoucí účinky</td><td>4. Bivirkninger</td><td>4. Welche Nebenwirkungen sind möglich?</td><td>4. Πιθανές ανεπιθύμητες ενέργειες</td><td>4. Possible side effects</td><td>4. Posibles efectos adversos</td><td>4. Võimalikud kõrvaltoimed</td><td>4. Mahdolliset haittavaikutukset</td><td>4. Quels sont les effets indésirables éventuels?</td><td>4. Fo-iarsmaí féideartha</td><td>4. Moguće nuspojave</td><td>4. Lehetséges mellékhatások</td><td>4. Hugsanlegar aukaverkanir</td><td>4. Possibili effetti indesiderati</td><td>4. Galimas šalutinis poveikis</td><td>4. Iespējamās blakusparādības</td><td>4. Effetti sekondarji possibbli</td><td>4. Mogelijke bijwerkingen</td><td>4. Mulige bivirkninger</td><td>4. Możliwe działania niepożądane</td><td>4. Efeitos indesejáveis possíveis</td><td>4. Reacții adverse posibile</td><td>4. Možné vedľajšie účinky</td><td>4. Možni neželeni učinki</td><td>4. Eventuella biverkningar</td></tr><tr><td>200000029911</td><td>Допълнителни нежелани реакции при деца [и юноши]</td><td>Další nežádoucí účinky u dětí [a dospívajících]</td><td>Hos børn [og unge] kan endvidere ses følgende bivirkninger:</td><td>Zusätzliche Nebenwirkungen bei Kindern [und Jugendlichen]</td><td>Συμπληρωματικές ανεπιθύμητες ενέργειες σε παιδιά [και εφήβους]</td><td>Additional side effects in children [and adolescents]</td><td>Otros efectos adversos en niños [y adolescentes]</td><td>Täiendavad kõrvaltoimed lastel [ja noorukitel]</td><td>Muut haittavaikutukset lapsilla [ja nuorilla]</td><td>Effets indésirables supplémentaires chez les enfants [et les adolescents]</td><td>Fo-iarsmaí breise i leanaí [agus in ógánaigh]</td><td>Dodatne nuspojave u djece [i adolescenata]</td><td>További mellékhatások gyermekeknél [és serdülőknél]</td><td>Aðrar aukaverkanir sem geta komið fyrir hjá börnum [og unglingum]</td><td>Effetti indesiderati aggiuntivi nei bambini [e negli adolescenti]</td><td>Kitas šalutinis poveikis, kuris gali pasireikšti vaikams [ir paaugliams]</td><td>Papildu blakusparādības bērniem [un pusaudžiem]</td><td>Effetti sekondarji oħra fit-tfal [u l-adolexxenti]</td><td>Extra bijwerkingen die bij kinderen [en jongeren tot 18 jaar] kunnen voorkomen</td><td>Bivirkninger som kan forekomme hos barn [og ungdom]</td><td>Dodatkowe działania niepożądane u dzieci [i młodzieży]</td><td>Efeitos indesejáveis adicionais em crianças [e adolescentes]</td><td>Reacții adverse suplimentare la copii [și adolescenți]</td><td>Ďalšie vedľajšie účinky u detí [a dospievajúcich]</td><td>Dodatni neželeni učinki pri otrocih [in mladostnikih]</td><td>Ytterligare biverkningar hos barn [och ungdomar]</td></tr><tr><td>200000029912</td><td>Съобщаване на нежелани реакции</td><td>Hlášení nežádoucích účinků</td><td>Indberetning af bivirkninger</td><td>Meldung von Nebenwirkungen</td><td>Αναφορά ανεπιθύμητων ενεργειών</td><td>Reporting of side effects</td><td>Comunicación de efectos adversos</td><td>Kõrvaltoimetest teatamine</td><td>Haittavaikutuksista ilmoittaminen</td><td>Déclaration des effets secondaires</td><td>Fo-iarsmaí a thuairisciú</td><td>Prijavljivanje nuspojava</td><td>Mellékhatások bejelentése</td><td>Tilkynning aukaverkana</td><td>Segnalazione degli effetti indesiderati</td><td>Pranešimas apie šalutinį poveikį</td><td>Ziņošana par blakusparādībām</td><td>Rappurtar tal-effetti sekondarji</td><td>Het melden van bijwerkingen</td><td>Melding av bivirkninger</td><td>Zgłaszanie działań niepożądanych</td><td>Comunicação de efeitos indesejáveis</td><td>Raportarea reacțiilor adverse</td><td>Hlásenie vedľajších účinkov</td><td>Poročanje o neželenih učinkih</td><td>Rapportering av biverkningar</td></tr><tr><td>200000029913</td><td>5. Как да съхранявате X</td><td>5. Jak [přípravek] X uchovávat</td><td>5. Opbevaring</td><td>5. Wie ist X aufzubewahren?</td><td>5. Πώς να φυλάσσετε το Χ</td><td>5. How to store X</td><td>5. Conservación de X</td><td>5. Kuidas X’i säilitada</td><td>5. [X:n] [X-valmisteen] säilyttäminen</td><td>5. Comment conserver X</td><td>5. Conas X a stóráil</td><td>5. Kako čuvati X</td><td>5. Hogyan kell a(z) X-et tárolni?</td><td>5. Hvernig geyma á X</td><td>5. Come conservare X</td><td>5. Kaip laikyti X</td><td>5. Kā uzglabāt X</td><td>5. Kif taħżen X</td><td>5. Hoe bewaart u dit middel?</td><td>5. Hvordan du oppbevarer X</td><td>5. Jak przechowywać [lek] X</td><td>5. Como conservar X</td><td>5. Cum se păstrează X</td><td>5. Ako uchovávať X</td><td>5. Shranjevanje zdravila X</td><td>5. Hur X ska förvaras</td></tr><tr><td>200000029914</td><td>6. Съдържание на опаковката и допълнителна информация</td><td>6. Obsah balení a další informace</td><td>6. Pakningsstørrelser og yderligere oplysninger</td><td>6. Inhalt der Packung und weitere Informationen</td><td>6. Περιεχόμενα της συσκευασίας και λοιπές πληροφορίες</td><td>6. Contents of the pack and other information</td><td>6. Contenido del envase e información adicional</td><td>6. Pakendi sisu ja muu teave</td><td>6. Pakkauksen sisältö ja muuta tietoa</td><td>6. Contenu de l’emballage et autres informations</td><td>6. Inneachar an phacáiste agus faisnéis eile</td><td>6. Sadržaj pakiranja i druge informacije</td><td>6. A csomagolás tartalma és egyéb információk</td><td>6. Pakkningar og aðrar upplýsingar</td><td>6. Contenuto della confezione e altre informazioni</td><td>6. Pakuotės turinys ir kita informacija</td><td>6. Iepakojuma saturs un cita informācija</td><td>6. Kontenut tal-pakkett u informazzjoni oħra</td><td>6. Inhoud van de verpakking en overige informatie</td><td>6. Innholdet i pakningen og ytterligere informasjon</td><td>6. Zawartość opakowania i inne informacje</td><td>6. Conteúdo da embalagem e outras informações</td><td>6. Conținutul ambalajului și alte informații</td><td>6. Obsah balenia a ďalšie informácie</td><td>6. Vsebina pakiranja in dodatne informacije</td><td>6. Förpackningens innehåll och övriga upplysningar</td></tr><tr><td>200000029915</td><td>Какво съдържа X</td><td>Co [přípravek] X obsahuje</td><td>{X} indeholder:</td><td>Was X enthält</td><td>Τι περιέχει το Χ</td><td>What X contains</td><td>Composición de X</td><td>Mida X sisaldab</td><td>Mitä X sisältää</td><td>Ce que contient X</td><td>A bhfuil in X</td><td>Što X sadrži</td><td>Mit tartalmaz a(z) X?</td><td>X inniheldur</td><td>Cosa contiene X</td><td>X sudėtis</td><td>Ko X satur</td><td>X’fih X</td><td>Welke stoffen zitten er in dit middel?</td><td>Sammensetning av X</td><td>Co zawiera [lek] X</td><td>Qual a composição de X</td><td>Ce conține X</td><td>Čo X obsahuje</td><td>Kaj vsebuje zdravilo X</td><td>Innehållsdeklaration</td></tr><tr><td>200000029916</td><td>Как изглежда X и какво съдържа опаковката</td><td>Jak[přípravek] X vypadá a co obsahuje toto balení</td><td>Udseende og pakningsstørrelser</td><td>Wie X aussieht und Inhalt der Packung</td><td>Εμφάνιση του Χ και περιεχόμενα της συσκευασίας</td><td>What X looks like and contents of the pack</td><td>Aspecto del producto y contenido del envase</td><td>Kuidas X välja näeb ja pakendi sisu</td><td>Lääkevalmisteen kuvaus ja pakkauskoko (-koot)</td><td>Comment se présente X et contenu de l’emballage extérieur</td><td>An chuma atá ar X agus inneachar an phacáiste</td><td>Kako X izgleda i sadržaj pakiranja</td><td>Milyen a(z) X külleme és mit tartalmaz a csomagolás?</td><td>Lýsing á útliti X og pakkningastærðir</td><td>Descrizione dell’aspetto di X e contenuto della confezione</td><td>X išvaizda ir kiekis pakuotėje</td><td>X ārējais izskats un iepakojums</td><td>Kif jidher X u l-kontenut tal-pakkett</td><td>Hoe ziet X eruit en hoeveel zit er in een verpakking?</td><td>Hvordan X ser ut og innholdet i pakningen</td><td>Jak wygląda [lek] X i co zawiera opakowanie</td><td>Qual o aspeto de X e conteúdo da embalagem</td><td>Cum arată X și conținutul ambalajului</td><td>Ako vyzerá X a obsah balenia</td><td>Izgled zdravila X in vsebina pakiranja</td><td>Läkemedlets utseende och förpackningsstorlekar</td></tr><tr><td>200000029917</td><td>Притежател на разрешението за употреба и производител</td><td>Držitel rozhodnutí o registraci a výrobce</td><td>Indehaver af markedsføringstilladelsen og fremstiller</td><td>Pharmazeutischer Unternehmer und Hersteller</td><td>Κάτοχος Άδειας Κυκλοφορίας και Παρασκευαστής</td><td>Marketing Authorisation Holder and Manufacturer</td><td>Titular de la autorización de comercialización y responsable de la fabricación</td><td>Müügiloa hoidja ja tootja</td><td>Myyntiluvan haltija ja valmistaja</td><td>Titulaire de l’Autorisation de mise sur le marché et fabricant</td><td>Sealbhóir an Údaraithe Margaíochta agus an Monaróir</td><td>Nositelj odobrenja za stavljanje lijeka u promet i proizvođač</td><td>A forgalomba hozatali engedély jogosultja és a gyártó</td><td>Markaðsleyfishafi og framleiðandi</td><td>Titolare dell’autorizzazione all’immissione in commercio e produttore</td><td>Registruotojas ir gamintojas</td><td>Reģistrācijas apliecības īpašnieks un ražotājs</td><td>Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur</td><td>Houder van de vergunning voor het in de handel brengen en fabrikant</td><td>Innehaver av markedsføringstillatelsen og tilvirker</td><td>Podmiot odpowiedzialny i wytwórca</td><td>Titular da Autorização de Introdução no Mercado e Fabricante</td><td>Deținătorul autorizației de punere pe piață și fabricantul</td><td>Držiteľ rozhodnutia o registrácii a výrobca</td><td>Imetnik dovoljenja za promet z zdravilom in proizvajalec</td><td>Innehavare av godkännande för försäljning och tillverkare</td></tr><tr><td>200000029918</td><td>Това лекарство е разрешено за употреба в държавите ― членки на Европейското икономическо пространство, [и в Обединеното кралство (Северна Ирландия)] под следните имена:</td><td>Tento léčivý přípravek je v členských státech Evropského hospodářského prostoru [a ve Spojeném království (Severním Irsku)] registrován pod těmito názvy:</td><td>Dette lægemiddel er godkendt i medlemslandene i Det Europæiske Økonomiske Samarbejdsområde [og i Det Forenede Kongerige (Nordirland)] under følgende navne:</td><td>Dieses Arzneimittel ist in den Mitgliedsstaaten des Europäischen Wirtschaftsraumes (EWR) [und im Vereinigten Königreich (Nordirland)] unter den folgenden Bezeichnungen zugelassen:</td><td>Αυτό το φάρμακο έχει εγκριθεί στα Κράτη Μέλη του Ευρωπαϊκού Οικονομικού Χώρου (ΕΟΧ) [και στο Ηνωμένο Βασίλειο (Βόρεια Ιρλανδία)] με τις ακόλουθες ονομασίες:</td><td>This medicine is authorised in the Member States of the European Economic Area [and in the United Kingdom (Northern Ireland)] under the following names:</td><td>Este medicamento está autorizado en los estados miembros del Espacio Económico Europeo [y en el Reino Unido (Irlande del Norte)] con los siguientes nombres:</td><td>See ravim on saanud müügiloa Euroopa Majanduspiirkonna liikmesriikides [ja Ühendkuningriigis (Põhja-Iirimaal)] järgmiste nimetustega:</td><td>Tällä lääkkeellä on myyntilupa Euroopan talousalueeseen kuuluvissa jäsenvaltioissa [ja Yhdistyneessä kuningaskunnassa (Pohjois-Irlannissa)] seuraavilla kauppanimillä:</td><td>Ce médicament est autorisé dans les Etats membres de l'Espace Economique Européen [et au Royaume-Uni (Irlande du Nord)] sous les noms suivants :</td><td>Tá an cógas seo údaraithe i mBallstáit an Limistéir Eorpaigh Eacnamaíoch [agus sa Ríocht Aontaithe (Tuaisceart Éireann)] faoi na hainmneacha seo a leanas:</td><td>Ovaj lijek odobren je u državama članicama Europskog gospodarskog prostora i Ujedinjenoj Kraljevini (Sjevernoj Irskoj) pod sljedećim nazivima:</td><td>Ezt a gyógyszert az Európai Gazdasági Térség tagállamaiban [és az Egyesült Királyságban (Észak-Írországban)] az alábbi neveken engedélyezték:</td><td>Þetta lyf hefur markaðsleyfi í löndum Evrópska efnahagssvæðisins [og í Bretlandi (Norður-Írland)] undir eftirfarandi heitum:</td><td>Questo medicinale è autorizzato negli Stati Membri dello Spazio economico europeo [e nel Regno Unito (Irlanda del Nord)] con le seguenti denominazioni:</td><td>Šis vaistas Europos ekonominės erdvės valstybėse narėse [ir Jungtinėje Karalystėje (Šiaurės Airijoje)] registruotas tokiais pavadinimais:</td><td>Šīs zāles Eiropas Ekonomikas zonas (EEZ) dalībvalstīs [un Apvienotajā Karalistē (Ziemļīrijā)] ir reģistrētas ar šādiem nosaukumiem:</td><td>Dan il-prodott mediċinali huwa awtorizzat fl-Istati Membri taż-Żona Ekonomika Ewropea u fir-Renju Unit tal-Irlanda (l-Irlanda ta’ Fuq) b'dawn l-ismijiet li ġejjin:</td><td>Dit medicijn is geregistreerd in lidstaten van de Europese Economische Ruimte [en in het Verenigd Koninkrijk (Noord-Ierland)] onder de volgende namen:</td><td>Dette legemidlet er godkjent i medlemsstatene i Det europeiske økonomiske samarbeidsområde [og i Storbritannia (Nord-Irland)] med følgende navn:</td><td>Ten lek jest dopuszczony do obrotu w krajach członkowskich Europejskiego Obszaru Gospodarczego [i w Zjednoczonym Królestwie (Irlandii Północnej)] pod następującymi nazwami:</td><td>Este medicamento encontra-se autorizado nos Estados Membros do Espaço Económico Europeu (EEE) [e no Reino Unido (Irlanda do Norte)] com os seguintes nomes:</td><td>Acest medicament este autorizat în statele membre ale Spaţiului Economic European și în Regatul Unit (Irlanda de Nord) sub următoarele denumiri comerciale:</td><td>Liek je schválený v členských štátoch Európskeho hospodárskeho priestoru [a v Spojenom kráľovstve (Severnom Írsku)] pod nasledovnými názvami:</td><td>Zdravilo je v državah članicah Evropskega gospodarskega prostora in Združenem kraljestvu (Severnem Irskem) pridobilo dovoljenje za promet z naslednjimi imeni:</td><td>Detta läkemedel är godkänt inom Europeiska ekonomiska samarbetsområdet [och i Förenade kungariket (Nordirland)] under namnen:</td></tr><tr><td>200000029919</td><td>Дата на последно преразглеждане на листовката [{ММ /ГГГГ}] [{месец ГГГГ}].</td><td>Tato příbalová informace byla naposledy revidována [{DD. MM. RRRR}] [{MM/RRRR}] [{měsíc RRRR}].</td><td>Denne indlægsseddel blev senest ændret [{MM/ÅÅÅÅ}] [{måned ÅÅÅÅ}.]</td><td>Diese Packungsbeilage wurde zuletzt überarbeitet im [{MM.JJJJ}] [{Monat JJJJ}].</td><td>Το παρόν φύλλο οδηγιών χρήσης αναθεωρήθηκε για τελευταία φορά στις [{ΜΜ/ΕΕΕΕ}] [{μήνας ΕΕΕΕ}.]</td><td>This leaflet was last revised in [{MM/YYYY}][{month YYYY}].</td><td>Fecha de la última revisión de este prospecto: [{MM/AAAA}][{mes AAAA}].</td><td>Infoleht on viimati uuendatud [KK.AAAA] [kuu AAAA].</td><td>Tämä pakkausseloste on tarkistettu viimeksi [{KK.VVVV}] [{kuukausi VVVV}].</td><td>La dernière date à laquelle cette notice a été révisée est [{MM/AAAA}] [{mois AAAA}.</td><td>Rinneadh athbhreithniú den uair dheireanach ar an mbileog seo i [{MM/BBBB}][mí YYYY}].</td><td>Ova uputa je zadnji puta revidirana u [{MM/GGGG}] [{mjesec GGGG}].</td><td>A betegtájékoztató legutóbbi felülvizsgálatának dátuma:[{ÉÉÉÉ. hónap}]</td><td>Þessi fylgiseðill var síðast uppfærður [{MM/ÁÁÁÁ}] [í {mánuður ÁÁÁÁ}].</td><td>Questo foglio illustrativo è stato aggiornato [{MM/AAAA}][{mese AAAA}].</td><td>Šis pakuotės lapelis paskutinį kartą peržiūrėtas [{MMMM m. {mėnesio} mėn.}.].</td><td>Šī lietošanas instrukcija pēdējo reizi pārskatīta [{MM/GGGG}] [GGGG. gada mēnesis}]</td><td>Dan il-fuljett kien rivedut l-aħħar f’ [{XX/SSSS} ][{xahar SSSS} ].</td><td>Deze bijsluiter is voor het laatst goedgekeurd in [{MM/JJJJ}] [{maand JJJJ}].</td><td>Dette pakningsvedlegget ble sist oppdatert [{MM/ÅÅÅÅ}] [{måned ÅÅÅÅ}].</td><td>Data ostatniej aktualizacji ulotki: [{MM/RRRR}][{miesiąc RRRR}].</td><td>Este folheto foi revisto pela última vez em [{MM/AAAA}][{mês de AAAA}.]</td><td>Acest prospect a fost revizuit în [{LL/AAAA}][{luna AAAA}].</td><td>Táto písomná informácia bola naposledy aktualizovaná v [{MM/RRRR}] [{mesiac RRRR}].</td><td>Navodilo je bilo nazadnje revidirano dne [{MM/LLLL}] [{mesec LLLL}]</td><td>Denna bipacksedel ändrades senast [{MM/ÅÅÅÅ}][{månad ÅÅÅÅ}]</td></tr><tr><td>200000029920</td><td>Други източници на информация</td><td>Další zdroje informací</td><td>Andre informationskilder</td><td>Weitere Informationsquellen</td><td>Άλλες πηγές πληροφοριών</td><td>Other sources of information</td><td>Otras fuentes de información</td><td>Muud teabeallikad</td><td>Muut tiedonlähteet</td><td>Autres sources d’informations</td><td>Foinsí eile faisnéise</td><td>Ostali izvori informacija</td><td>Egyéb információforrások</td><td>Upplýsingar sem hægt er að nálgast annars staðar</td><td>Altre fonti d’informazioni</td><td>Kiti informacijos šaltiniai</td><td>Citi informācijas avoti</td><td>Sorsi oħra ta’ informazzjoni</td><td>Andere informatiebronnen</td><td>Andre informasjonskilder</td><td>Inne źródła informacji</td><td>Outras fontes de informação</td><td>Alte surse de informații</td><td>Ďalšie zdroje informácií</td><td>Drugi viri informacij</td><td>Övriga informationskällor</td></tr><tr><td>200000029921</td><td>Посочената по-долу информация е предназначена само за медицински специалисти:</td><td>Následující informace jsou určeny pouze pro zdravotnické pracovníky:</td><td>Nedenstående oplysninger er kun til sundhedspersoner:</td><td>Die folgenden Informationen sind für medizinisches Fachpersonal bestimmt:</td><td>Οι πληροφορίες που ακολουθούν απευθύνονται μόνο σε επαγγελματίες υγείας:</td><td>The following information is intended for healthcare professionals only:</td><td>Esta información está destinada únicamente a profesionales sanitarios:</td><td>Järgmine teave on ainult tervishoiutöötajatele:</td><td>Seuraavat tiedot on tarkoitettu vain terveydenhuollon ammattilaisille:</td><td>Les informations suivantes sont destinées exclusivement aux professionnels de la santé:</td><td>Níl an fhaisnéis seo a leanas ach do ghairmithe cúraim sláinte:</td><td>Sljedeće informacije namijenjene su samo zdravstvenim radnicima:</td><td>Az alábbi információk kizárólag egészségügyi szakembereknek szólnak:</td><td>Eftirfarandi upplýsingar eru einungis ætlaðar heilbrigðisstarfsmönnum:</td><td>Le informazioni seguenti sono destinate esclusivamente agli operatori sanitari:</td><td>Toliau pateikta informacija skirta tik sveikatos priežiūros specialistams.</td><td>Tālāk sniegtā informācija paredzēta tikai veselības aprūpes speciālistiem.</td><td>It-tagħrif li jmiss qed jingħata biss għall-professjonisti tal-kura tas-saħħa biss:</td><td>De volgende informatie is alleen bestemd voor beroepsbeoefenaren in de gezondheidszorg:</td><td>Påfølgende informasjon er bare beregnet på helsepersonell:</td><td>Informacje przeznaczone wyłącznie dla fachowego personelu medycznego:</td><td>A informação que se segue destina-se apenas aos profissionais de saúde:</td><td>Următoarele informații sunt destinate numai profesioniștilor din domeniul sănătății:</td><td>Nasledujúca informácia je určená len pre zdravotníckych pracovníkov:</td><td>Naslednje informacije so namenjene samo zdravstvenemu osebju:</td><td>Följande uppgifter är endast avsedda för hälso- och sjukvårdspersonal:</td></tr><tr><td>200000044346</td><td>ниво=H3 PL персонализиран подраздел</td><td>Uroveň=H3 PL vlastní podsekce</td><td>Niveau=H3 PL brugerdefineret underafsnit</td><td>Ebene=H3 PL benutzerdefinierter unterabschnitt</td><td>επίπεδο=H3 PL προσαρμοσμένη υποενότητα</td><td>Level=H3 PL custom subsection</td><td>Nivel=H3 PL subsección personalizada</td><td>Tase=H3 PL kohandatud alajaotis</td><td>Taso=H3 PL mukautettu alaosio</td><td>Niveau=H3 PL sous-section personnalisée</td><td>Leibhéal=H3 PL fo-alt saincheaptha</td><td>Razina=H3 PL prilagođeni pododjeljak</td><td>Szint=H3 PL egyéni alfejezet</td><td>Stig=H3 PL sérsniðin undirkafli</td><td>Livello=H3 PL sottosezione personalizzata</td><td>Lygis=H3 PL pritaikyta poskyris</td><td>Līmenis=H3 PL pielāgota apakšnodaļa</td><td>Livell=H3 PL sottotaqsima personalizzata</td><td>Niveau=H3 PL aangepaste subsectie</td><td>Nivå=H3 PL tilpasset underavsnitt</td><td>Poziom=H3 PL niestandardowa podsekcja</td><td>Nível=H3 PL subseção personalizada</td><td>Nivel=H3 PL subsecțiune personalizată</td><td>Úroveň=H3 PL vlastná podsekcia</td><td>Raven=H3 PL prilagojeni pododdelek</td><td>Nivå=H3 PL anpassad underavdelning</td></tr><tr><td>200000044333</td><td>ниво=H4 SmPC персонализиран подраздел</td><td>Uroveň=H4 SmPC vlastní podsekce</td><td>Niveau=H4 SmPC brugerdefineret underafsnit</td><td>Ebene=H4 SmPC benutzerdefinierter unterabschnitt</td><td>επίπεδο=H4 SmPC προσαρμοσμένη υποενότητα</td><td>Level=H4 SmPC custom subsection</td><td>Nivel=H4 SmPC subsección personalizada</td><td>Tase=H4 SmPC kohandatud alajaotis</td><td>Taso=H4 SmPC mukautettu alaosio</td><td>Niveau=H4 SmPC sous-section personnalisée</td><td>Leibhéal=H4 SmPC fo-alt saincheaptha</td><td>Razina=H4 SmPC prilagođeni pododjeljak</td><td>Szint=H4 SmPC egyéni alfejezet</td><td>Stig=H4 SmPC sérsniðin undirkafli</td><td>Livello=H4 SmPC sottosezione personalizzata</td><td>Lygis=H4 SmPC pritaikyta poskyris</td><td>Līmenis=H4 SmPC pielāgota apakšnodaļa</td><td>Livell=H4 SmPC sottotaqsima personalizzata</td><td>Niveau=H4 SmPC aangepaste subsectie</td><td>Nivå=H4 SmPC tilpasset underavsnitt</td><td>Poziom=H4 SmPC niestandardowa podsekcja</td><td>Nível=H4 SmPC subseção personalizada</td><td>Nivel=H4 SmPC subsecțiune personalizată</td><td>Úroveň=H4 SmPC vlastná podsekcia</td><td>Raven=H4 SmPC prilagojeni pododdelek</td><td>Nivå=H4 SmPC PL anpassad underavdelning</td></tr><tr><td>200000044347</td><td>ниво=H5 SmPC персонализиран подраздел</td><td>Uroveň=H5 SmPC vlastní podsekce</td><td>Niveau=H5 SmPC brugerdefineret underafsnit</td><td>Ebene=H5 SmPC benutzerdefinierter unterabschnitt</td><td>επίπεδο=H5 SmPC προσαρμοσμένη υποενότητα</td><td>Level=H5 SmPC custom subsection</td><td>Nivel=H5 SmPC subsección personalizada</td><td>Tase=H5 SmPC kohandatud alajaotis</td><td>Taso=H5 SmPC mukautettu alaosio</td><td>Niveau=H5 SmPC sous-section personnalisée</td><td>Leibhéal=H5 SmPC fo-alt saincheaptha</td><td>Razina=H5 SmPC prilagođeni pododjeljak</td><td>Szint=H5 SmPC egyéni alfejezet</td><td>Stig=H5 SmPC sérsniðin undirkafli</td><td>Livello=H5 SmPC sottosezione personalizzata</td><td>Lygis=H5 SmPC pritaikyta poskyris</td><td>Līmenis=H5 SmPC pielāgota apakšnodaļa</td><td>Livell=H5 SmPC sottotaqsima personalizzata</td><td>Niveau=H5 SmPC aangepaste subsectie</td><td>Nivå=H5 SmPC tilpasset underavsnitt</td><td>Poziom=H5 SmPC niestandardowa podsekcja</td><td>Nível=H5 SmPC subseção personalizada</td><td>Nivel=H5 SmPC subsecțiune personalizată</td><td>Úroveň=H5 SmPC vlastná podsekcia</td><td>Raven=H5 SmPC prilagojeni pododdelek</td><td>Nivå=H5 SmPC PL anpassad underavdelning</td></tr></table></div>
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  <date value="2025-04-02T11:27:42+01:00"/>
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  <description
               value="Section codes allowed in EU EPI document compositions, defined in EMA's Referentials Management Service."/>
  <caseSensitive value="false"/>
  <content value="complete"/>
  <count value="135"/>
  <concept>
    <code value="000000000000"/>
    <display value="Code for custom sub-sections (reserved)"/>
  </concept>
  <concept>
    <code value="200000029791"/>
    <display value="SUMMARY OF PRODUCT CHARACTERISTICS"/>
    <designation>
      <language value="en"/>
      <value value="SUMMARY OF PRODUCT CHARACTERISTICS"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="SAŽETAK OPISA SVOJSTAVA LIJEKA"/>
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    <designation>
      <language value="cs"/>
      <value value="SOUHRN ÚDAJŮ O PŘÍPRAVKU"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="PRODUKTRESUMÉ"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="SAMENVATTING VAN DE PRODUCTKENMERKEN"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="RAVIMI OMADUSTE KOKKUVÕTE"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="VALMISTEYHTEENVETO"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="RÉSUMÉ DES CARACTÉRISTIQUES DU PRODUIT"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="ZUSAMMENFASSUNG DER MERKMALE DES ARZNEIMITTELS"/>
    </designation>
    <designation>
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      <value value="ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ"/>
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    <designation>
      <language value="ga"/>
      <value value="ACHOIMRE AR SHAINTRÉITHE AN TÁIRGE"/>
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    <designation>
      <language value="it"/>
      <value value="RIASSUNTO DELLE CARATTERISTICHE DEL PRODOTTO"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="ZĀĻU APRAKSTS"/>
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    <designation>
      <language value="lt"/>
      <value value="PREPARATO CHARAKTERISTIKŲ SANTRAUKA"/>
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    <designation>
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      <value value="SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT"/>
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    <designation>
      <language value="no"/>
      <value value="PREPARATOMTALE"/>
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    <designation>
      <language value="pl"/>
      <value value="CHARAKTERYSTYKA PRODUKTU LECZNICZEGO"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="RESUMO DAS CARACTERÍSTICAS DO MEDICAMENTO"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="REZUMATUL CARACTERISTICILOR PRODUSULUI"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="SÚHRN CHARAKTERISTICKÝCH VLASTNOSTÍ LIEKU"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA"/>
    </designation>
    <designation>
      <language value="es"/>
      <value
             value="FICHA TÉCNICA O RESUMEN DE LAS CARACTERÍSTICAS DEL PRODUCTO"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="PRODUKTRESUMÉ"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029792"/>
    <display value="1. NAME OF THE MEDICINAL PRODUCT"/>
    <designation>
      <language value="en"/>
      <value value="1. NAME OF THE MEDICINAL PRODUCT"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="1. ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="1. NAZIV LIJEKA"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="1. NÁZEV PŘÍPRAVKU"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="1. LÆGEMIDLETS NAVN"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="1. NAAM VAN HET GENEESMIDDEL"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="1. RAVIMPREPARAADI NIMETUS"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="1. LÄÄKEVALMISTEEN NIMI"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="1. DÉNOMINATION DU MÉDICAMENT"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="1. BEZEICHNUNG DES ARZNEIMITTELS"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="1. ΟΝΟΜΑΣΙΑ ΤΟΥ ΦΑΡΜΑΚΕΥΤΙΚΟΥ ΠΡΟΪΟΝΤΟΣ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="1. A GYÓGYSZER NEVE"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="1. HEITI LYFS"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="1. AINM AN TÁIRGE ÍOCSHLÁINTE"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="1. DENOMINAZIONE DEL MEDICINALE"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="1. ZĀĻU NOSAUKUMS"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="1. VAISTINIO PREPARATO PAVADINIMAS"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="1. ISEM IL-PRODOTT MEDIĊINALI"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="1. LEGEMIDLETS NAVN"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="1. NAZWA PRODUKTU LECZNICZEGO"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="1. NOME DO MEDICAMENTO"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="1. DENUMIREA COMERCIALĂ A MEDICAMENTULUI"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="1. NÁZOV LIEKU"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="1. IME ZDRAVILA"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="1. NOMBRE DEL MEDICAMENTO"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="1. LÄKEMEDLETS NAMN"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029793"/>
    <display value="2. QUALITATIVE AND QUANTITATIVE COMPOSITION"/>
    <designation>
      <language value="en"/>
      <value value="2. QUALITATIVE AND QUANTITATIVE COMPOSITION"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="2. КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="2. KVALITATIVNI I KVANTITATIVNI SASTAV"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="2. KVALITATIVNÍ A KVANTITATIVNÍ SLOŽENÍ"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="2. KVALITATIV OG KVANTITATIV SAMMENSÆTNING"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="2. KWALITATIEVE EN KWANTITATIEVE SAMENSTELLING"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="2. KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="2. VAIKUTTAVAT AINEET JA NIIDEN MÄÄRÄT"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="2. COMPOSITION QUALITATIVE ET QUANTITATIVE"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="2. QUALITATIVE UND QUANTITATIVE ZUSAMMENSETZUNG"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="2. ΠΟΙΟΤΙΚΗ ΚΑΙ ΠΟΣΟΤΙΚΗ ΣΥΝΘΕΣΗ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="2. MINŐSÉGI ÉS MENNYISÉGI ÖSSZETÉTEL"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="2. INNIHALDSLÝSING"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="2. COMHDHÉANAMH CÁILÍOCHTÚIL AGUS CAINNÍOCHTÚIL"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="2. COMPOSIZIONE QUALITATIVA E QUANTITATIVA"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="2. KVALITATĪVAIS UN KVANTITATĪVAIS SASTĀVS"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="2. KOKYBINĖ IR KIEKYBINĖ SUDĖTIS"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="2. GĦAMLA KWALITATTIVA U KWANTITATTIVA"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="2. KVALITATIV OG KVANTITATIV SAMMENSETNING"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="2. SKŁAD JAKOŚCIOWY I ILOŚCIOWY"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="2. COMPOSIÇÃO QUALITATIVA E QUANTITATIVA"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="2. COMPOZIȚIA CALITATIVĂ ȘI CANTITATIVĂ"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="2. KVALITATÍVNE A KVANTITATÍVNE ZLOŽENIE"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="2. KAKOVOSTNA IN KOLIČINSKA SESTAVA"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="2. COMPOSICIÓN CUALITATIVA Y CUANTITATIVA"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="2. KVALITATIV OCH KVANTITATIV SAMMANSÄTTNING"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029794"/>
    <display value="2.1 General description"/>
    <designation>
      <language value="en"/>
      <value value="2.1 General description"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="2.1 Общо описание"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="2.1 Opći opis"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="2.1 Obecný popis"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="2.1 Generel beskrivelse"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="2.1 Algemene beschrijving"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="2.1 Üldkirjeldus"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="2.1 Yleiskuvaus"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="2.1 Description générale"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="2.1 Allgemeine Beschreibung"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="2.1 Γενική περιγραφή"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="2.1 Általános leírás"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="2.1 Almenn lýsing"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="2.1 Cur síos ginearálta"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="2.1 Descrizione generale"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="2.1. Vispārējs apraksts"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="2.1 Bendras aprašymas"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="2.1 Deskrizzjoni ġenerali"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="2.1 Generell beskrivelse"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="2.1 Opis ogólny"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="2.1 Descrição geral"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="2.1 Descriere generală"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="2.1 Všeobecný opis"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="2.1 Splošen opis"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="2.1 Descripción general"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="2.1 Allmän beskrivning"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029795"/>
    <display value="2.2 Qualitative and quantitative composition"/>
    <designation>
      <language value="en"/>
      <value value="2.2 Qualitative and quantitative composition"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="2.2 Качествен и количествен състав"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="2.2 Kvalitativni i kvantitativni sastav"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="2.2 Kvalitativní a kvantitativní složení"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="2.2 Kvalitativ og kvantitativ sammensætning"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="2.2 Kwalitatieve en kwantitatieve samenstelling"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="2.2 Kvalitatiivne ja kvantitatiivne koostis"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="2.2 Vaikuttavat aineet ja niiden määrät"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="2.2 Composition qualitative et quantitative"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="2.2 Qualitative und quantitative Zusammensetzung"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="2.2 Ποιοτική και ποσοτική σύνθεση"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="2.2 Minőségi és mennyiségi összetétel"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="2.2 Innihaldslýsing"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="2.2 Comhdhéanamh cáilíochtúil agus cainníochtúil"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="2.2 Composizione qualitativa e quantitativa"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="2.2. Kvalitatīvais un kvantitatīvais sastāvs"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="2.2 Kokybinė ir kiekybinė sudėtis"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="2.2. Għamla kwalitattiva u kwantitattiva"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="2.2 Kvalitativ og kvantitativ sammensetning"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="2.2 Skład jakościowy i ilościowy"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="2.2 Composição qualitativa e quantitativa"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="2.2 Compoziția calitativă și cantitativă"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="2.2 Kvalitatívne a kvantitatívne zloženie"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="2.2 Kakovostna in količinska sestava"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="2.2 Composición cualitativa y cuantitativa"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="2.2 Kvalitativ och kvantitativ sammansättning"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029796"/>
    <display value="Excipient(s) with known effect"/>
    <designation>
      <language value="en"/>
      <value value="Excipient(s) with known effect"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Помощно(и) вещество(а) с известно действие"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Pomoćna(e) tvar(i) s poznatim učinkom"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="[Pomocná látka] [Pomocné látky] se známým účinkem"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Hjælpestof(fer), som behandleren skal være opmærksom på"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Hulpstof(fen) met bekend effect"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Teadaolevat toimet omav(ad) abiaine(d)"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Apuaine(et), joiden vaikutus tunnetaan"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Excipient(s) à effet notoire:"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Sonstige(r) Bestandteil(e) mit bekannter Wirkung"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Έκδοχο(α) με γνωστή δράση"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Ismert hatású segédanyag(ok)"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Hjálparefni með þekkta verkun"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value
             value="Támhán nó támháin a bhfuil éifeacht aitheanta aige nó acu"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Eccipiente(i) con effetti noti"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Palīgviela(-s) ar zināmu iedarbību"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value
             value="Pagalbinė (-s) medžiaga (-os), kurios (-ių) poveikis žinomas"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Eċċipjent(i) b’effett magħruf"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Hjelpestoff(er) med kjent effekt"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value
             value="Substancja pomocnicza] [Substancje pomocnicze] o znanym działaniu"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Excipiente(s) com efeito conhecido"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Excipient(ți) cu efect cunoscut"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="[Pomocná látka] [Pomocné látky] so známym účinkom"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Pomožna(e) snov(i) z znanim učinkom:"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Excipiente(s) con efecto conocido"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Hjälpämne(n) med känd effekt"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029797"/>
    <display value="3. PHARMACEUTICAL FORM"/>
    <designation>
      <language value="en"/>
      <value value="3. PHARMACEUTICAL FORM"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="3. ЛЕКАРСТВЕНА ФОРМА"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="3. FARMACEUTSKI OBLIK"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="3. LÉKOVÁ FORMA"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="3. LÆGEMIDDELFORM"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="3. FARMACEUTISCHE VORM"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="3. RAVIMVORM"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="3. LÄÄKEMUOTO"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="3. FORME PHARMACEUTIQUE"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="3. DARREICHUNGSFORM"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="3. ΦΑΡΜΑΚΟΤΕΧΝΙΚΗ ΜΟΡΦΗ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="3. GYÓGYSZERFORMA"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="3. LYFJAFORM"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="3. FOIRM CHÓGAISÍOCHTA"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="3. FORMA FARMACEUTICA"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="3. ZĀĻU FORMA"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="3. FARMACINĖ FORMA"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="3. GĦAMLA FARMAĊEWTIKA"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="3. LEGEMIDDELFORM"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="3. POSTAĆ FARMACEUTYCZNA"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="3. FORMA FARMACÊUTICA"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="3. FORMA FARMACEUTICĂ"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="3. LIEKOVÁ FORMA"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="3. FARMACEVTSKA OBLIKA"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="3. FORMA FARMACÉUTICA"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="3. LÄKEMEDELSFORM"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029798"/>
    <display value="4. CLINICAL PARTICULARS"/>
    <designation>
      <language value="en"/>
      <value value="4. CLINICAL PARTICULARS"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="4. КЛИНИЧНИ ДАННИ"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="4. KLINIČKI PODACI"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="4. KLINICKÉ ÚDAJE"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="4. KLINISKE OPLYSNINGER"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="4. KLINISCHE GEGEVENS"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="4. KLIINILISED ANDMED"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="4. KLIINISET TIEDOT"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="4. INFORMATIONS CLINIQUES"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="4. KLINISCHE ANGABEN"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="4. ΚΛΙΝΙΚΕΣ ΠΛΗΡΟΦΟΡΙΕΣ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="4. KLINIKAI JELLEMZŐK"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="4. KLÍNÍSKAR UPPLÝSINGAR"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="4. SONRAÍ CLINICIÚLA"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="4. INFORMAZIONI CLINICHE"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="4. KLĪNISKĀ INFORMĀCIJA"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="4. KLINIKINĖ INFORMACIJA"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="4. TAGĦRIF KLINIKU"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="4. KLINISKE OPPLYSNINGER"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="4. SZCZEGÓŁOWE DANE KLINICZNE"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="4. INFORMAÇÕES CLÍNICAS"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="4. DATE CLINICE"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="4. KLINICKÉ ÚDAJE"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="4. KLINIČNI PODATKI"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="4. DATOS CLÍNICOS"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="4. KLINISKA UPPGIFTER"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029799"/>
    <display value="4.1 Therapeutic indications"/>
    <designation>
      <language value="en"/>
      <value value="4.1 Therapeutic indications"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="4.1 Терапевтични показания"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="4.1 Terapijske indikacije"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="4.1 Terapeutické indikace"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="4.1 Terapeutiske indikationer"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="4.1 Therapeutische indicaties"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="4.1 Näidustused"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="4.1 Käyttöaiheet"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="4.1 Indications thérapeutiques"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="4.1 Anwendungsgebiete"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="4.1 Θεραπευτικές ενδείξεις"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="4.1 Terápiás javallatok"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="4.1 Ábendingar"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="4.1 Tásca teiripeacha"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="4.1 Indicazioni terapeutiche"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="4.1. Terapeitiskās indikācijas"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="4.1 Terapinės indikacijos"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="4.1 Indikazzjonijiet terapewtiċi"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="4.1 Indikasjon(er)"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="4.1 Wskazania do stosowania"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="4.1 Indicações terapêuticas"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="4.1 Indicații terapeutice"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="4.1 Terapeutické indikácie"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="4.1 Terapevtske indikacije"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="4.1 Indicaciones terapéuticas"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="4.1 Terapeutiska indikationer"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029800"/>
    <display value="4.2 Posology and method of administration"/>
    <designation>
      <language value="en"/>
      <value value="4.2 Posology and method of administration"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="4.2 Дозировка и начин на приложение"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="4.2 Doziranje i način primjene"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="4.2 Dávkování a způsob podání"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="4.2 Dosering og administration"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="4.2 Dosering en wijze van toediening"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="4.2 Annustamine ja manustamisviis"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="4.2 Annostus ja antotapa"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="4.2 Posologie et mode d’administration"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="4.2 Dosierung und Art der Anwendung"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="4.2 Δοσολογία και τρόπος χορήγησης"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="4.2 Adagolás és alkalmazás"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="4.2 Skammtar og lyfjagjöf"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="4.2 Poseolaíocht agus modh tabhartha"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="4.2 Posologia e modo di somministrazione"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="4.2. Devas un lietošanas veids"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="4.2 Dozavimas ir vartojimo metodas"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="4.2 Pożoloġija u metodu ta’ kif għandu jingħata"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="4.2 Dosering og administrasjonsmåte"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="4.2 Dawkowanie i sposób podawania"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="4.2 Posologia e modo de administração"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="4.2 Doze și mod de administrare"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="4.2 Dávkovanie a spôsob podávania"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="4.2 Odmerjanje in način uporabe"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="4.2 Posología y forma de administración"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="4.2 Dosering och administreringssätt"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029801"/>
    <display value="Posology"/>
    <designation>
      <language value="en"/>
      <value value="Posology"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Дозировка"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Doziranje"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Dávkování"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Dosering"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Dosering"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Annustamine"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Annostus"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Posologie"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Dosierung"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Δοσολογία"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Adagolás"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Skammtar"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Poseolaíocht"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Posologia"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Devas"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Dozavimas"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Pożoloġija"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Dosering"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Dawkowanie"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Posologia"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Doze"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Dávkovanie"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Odmerjanje"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Posología"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Dosering"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029802"/>
    <display value="Paediatric population"/>
    <designation>
      <language value="en"/>
      <value value="Paediatric population"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Педиатрична популация"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Pedijatrijska populacija"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Pediatrická populace"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Pædiatrisk population"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Pediatrische patiënten"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Lapsed"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Pediatriset potilaat"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Population pédiatrique"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Kinder und Jugendliche"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Παιδιατρικός πληθυσμός"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Gyermekek és serdülők"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Börn"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Daonra péidiatrach"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Popolazione pediatrica"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Pediatriskā populācija"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Vaikų populiacija"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Popolazzjoni pedjatrika"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Pediatrisk populasjon"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Dzieci i młodzież"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="População pediátrica"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Copii și adolescenți"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Pediatrická populácia"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Pediatrična populacija"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Población pediátrica"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Pediatrisk population"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029803"/>
    <display value="Method of administration"/>
    <designation>
      <language value="en"/>
      <value value="Method of administration"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Начин на приложение"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Način primjene"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Způsob podání"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Administration"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Wijze van toediening"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Manustamisviis"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Antotapa"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Mode d’administration"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Art der Anwendung"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Τρόπος χορήγησης"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Az alkalmazás módja"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Lyfjagjöf"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Modh tabhartha"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Modo di somministrazione"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Lietošanas veids"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Vartojimo metodas"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Metodu ta’ kif għandu jingħata"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Administrasjonsmåte"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Sposób podawania"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Modo de administração"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Mod de administrare"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Spôsob podávania"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Način uporabe"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Forma de administración"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Administreringssätt"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029804"/>
    <display
             value="Precautions to be taken before handling or administering the medicinal product"/>
    <designation>
      <language value="en"/>
      <value
             value="Precautions to be taken before handling or administering the medicinal product"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value
             value="Предпазни мерки, които трябва да бъдат взети преди работа със или приложение на лекарствения продукт"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value
             value="Mjere opreza koje je potrebno poduzeti prije rukovanja ili primjene lijeka."/>
    </designation>
    <designation>
      <language value="cs"/>
      <value
             value="Opatření, která je nutno učinit před zacházením s léčivým přípravkem nebo před jeho podáním"/>
    </designation>
    <designation>
      <language value="da"/>
      <value
             value="Sikkerhedsforanstaltninger, der skal tages før håndtering og administration af lægemidlet"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value
             value="Te nemen voorzorgen voorafgaand aan gebruik of toediening van het geneesmiddel"/>
    </designation>
    <designation>
      <language value="et"/>
      <value
             value="Enne ravimi käsitsemist või manustamist tuleb järgida ettevaatusabinõusid"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value
             value="Ennen lääkkeen käsittelyä tai antoa huomioon otettavat varotoimet"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value
             value="Précautions à prendre avant la manipulation ou l’administration du médicament"/>
    </designation>
    <designation>
      <language value="de"/>
      <value
             value="Vorsichtsmaßnahmen vor / bei der Handhabung bzw. vor / während der Anwendung des Arzneimittels"/>
    </designation>
    <designation>
      <language value="el"/>
      <value
             value="Προφυλάξεις που πρέπει να ληφθούν πριν από τον χειρισμό ή τη χορήγηση του φαρμακευτικού προϊόντος"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value
             value="Óvintézkedések a gyógyszer felhasználása vagy alkalmazása előtt"/>
    </designation>
    <designation>
      <language value="is"/>
      <value
             value="Varúðarráðstafanir sem þarf að gera áður en lyfið er meðhöndlað eða gefið"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value
             value="Réamhchúraimí le déanamh sula ndéantar an táirge íocshláinte a láimhsiú nó a thabhairt"/>
    </designation>
    <designation>
      <language value="it"/>
      <value
             value="Precauzioni che devono essere prese prima della manipolazione o della somministrazione del medicinale"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value
             value="Piesardzības pasākumi pirms zāļu lietošanas vai rīkošanās ar tām"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value
             value="Atsargumo priemonės prieš ruošiant ar vartojant šį vaistinį preparatą"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value
             value="Prekawzjonijiet li għandhom jittieħdu qabel tmiss il-prodott mediċinali jew qabel tagћti l-prodott mediċinali"/>
    </designation>
    <designation>
      <language value="no"/>
      <value
             value="Forholdsregler før håndtering eller administrering av dette legemidlet"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value
             value="Środki ostrożności, które należy podjąć przed użyciem lub podaniem produktu leczniczego"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value
             value="Precauções a ter em conta antes de manusear ou administrar o medicamento"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value
             value="Precauții care trebuie luate înainte de manipularea sau administrarea medicamentului"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Opatrenia pred zaobchádzaním alebo podaním lieku"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value
             value="Previdnostni ukrepi, potrebni pred ravnanjem z zdravilom ali dajanjem zdravila"/>
    </designation>
    <designation>
      <language value="es"/>
      <value
             value="Precauciones que se deben tomar antes de manipular o administrar el medicamento"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value
             value="Försiktighetsåtgärder före hantering eller administrering av läkemedlet"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029805"/>
    <display value="4.3 Contraindications"/>
    <designation>
      <language value="en"/>
      <value value="4.3 Contraindications"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="4.3 Противопоказания"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="4.3 Kontraindikacije"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="4.3 Kontraindikace"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="4.3 Kontraindikationer"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="4.3 Contra-indicaties"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="4.3 Vastunäidustused"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="4.3 Vasta-aiheet"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="4.3 Contre-indications"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="4.3 Gegenanzeigen"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="4.3 Αντενδείξεις"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="4.3 Ellenjavallatok"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="4.3 Frábendingar"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="4.3 Fritásca"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="4.3 Controindicazioni"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="4.3. Kontrindikācijas"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="4.3 Kontraindikacijos"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="4.3 Kontraindikazzjonijiet"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="4.3 Kontraindikasjoner"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="4.3 Przeciwwskazania"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="4.3 Contraindicações"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="4.3 Contraindicații"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="4.3 Kontraindikácie"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="4.3 Kontraindikacije"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="4.3 Contraindicaciones"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="4.3 Kontraindikationer"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029806"/>
    <display value="4.4 Special warnings and precautions for use"/>
    <designation>
      <language value="en"/>
      <value value="4.4 Special warnings and precautions for use"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value
             value="4.4 Специални предупреждения и предпазни мерки при употреба"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="4.4 Posebna upozorenja i mjere opreza pri uporabi"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="4.4 Zvláštní upozornění a opatření pro použitív"/>
    </designation>
    <designation>
      <language value="da"/>
      <value
             value="4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="4.4 Bijzondere waarschuwingen en voorzorgen bij gebruik"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="4.4 Erihoiatused ja ettevaatusabinõud kasutamisel"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="4.4 Varoitukset ja käyttöön liittyvät varotoimet"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="4.4 Mises en garde spéciales et précautions d’emploi"/>
    </designation>
    <designation>
      <language value="de"/>
      <value
             value="4.4 Besondere Warnhinweise und Vorsichtsmaßnahmen für die Anwendung"/>
    </designation>
    <designation>
      <language value="el"/>
      <value
             value="4.4 Ειδικές προειδοποιήσεις και προφυλάξεις κατά τη χρήση"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value
             value="4.4 Különleges figyelmeztetések és az alkalmazással kapcsolatos óvintézkedések"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="4.4 Sérstök varnaðarorð og varúðarreglur við notkun"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="4.4 Rabhaidh speisialta agus réamhchúraimí úsáide"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="4.4 Avvertenze speciali e precauzioni d’impiego"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="4.4. Īpaši brīdinājumi un piesardzība lietošanā"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="4.4 Specialūs įspėjimai ir atsargumo priemonės"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="4.4 Twissijiet speċjali u prekawzjonijiet għall-użu"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="4.4 Advarsler og forsiktighetsregler"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value
             value="4.4 Specjalne ostrzeżenia i środki ostrożności dotyczące stosowania"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="4.4 Advertências e precauções especiais de utilização"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="4.4 Atenționări și precauții speciale pentru utilizare"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="4.4 Osobitné upozornenia a opatrenia pri používaní"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="4.4 Posebna opozorila in previdnostni ukrepi"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="4.4 Advertencias y precauciones especiales de empleo"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="4.4 Varningar och försiktighet"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029807"/>
    <display value="Traceability"/>
    <designation>
      <language value="en"/>
      <value value="Traceability"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Проследимост"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Sljedivost"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Sledovatelnost"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Sporbarhed"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Terugvinden herkomst"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Jälgitavus"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Jäljitettävyys"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Traçabilité"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Rückverfolgbarkeit"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Ιχνηλασιμότητα"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Nyomonkövethetőség"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Rekjanleiki"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Inrianaitheacht"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Tracciabilità"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Izsekojamība"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Atsekamumas"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Traċċabilità"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Sporbarhet"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Identyfikowalność"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Rastreabilidade"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Trasabilitate"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Sledovateľnosť"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Sledljivost"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Trazabilidad"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Spårbarhet"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029808"/>
    <display value="Paediatric population"/>
    <designation>
      <language value="en"/>
      <value value="Paediatric population"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Педиатрична популация"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Pedijatrijska populacija"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Pediatrická populace"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Pædiatrisk population"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Pediatrische patiënten"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Lapsed"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Pediatriset potilaat"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Population pédiatrique"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Kinder und Jugendliche"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Παιδιατρικός πληθυσμός"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Gyermekek és serdülők"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Börn"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Daonra péidiatrach"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Popolazione pediatrica"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Pediatriskā populācija"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Vaikų populiacija"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Popolazzjoni pedjatrika"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Pediatrisk populasjon"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Dzieci i młodzież"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="População pediátrica"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Copii și adolescenți"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Pediatrická populácia"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Pediatrična populacija"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Población pediátrica"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Pediatrisk population"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029809"/>
    <display
             value="4.5 Interaction with other medicinal products and other forms of interaction"/>
    <designation>
      <language value="en"/>
      <value
             value="4.5 Interaction with other medicinal products and other forms of interaction"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value
             value="4.5 Взаимодействие с други лекарствени продукти и други форми на взаимодействие"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value
             value="4.5 Interakcije s drugim lijekovima i drugi oblici interakcija"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value
             value="4.5 Interakce s jinými léčivými přípravky a jiné formy interakce"/>
    </designation>
    <designation>
      <language value="da"/>
      <value
             value="4.5 Interaktion med andre lægemidler og andre former for interaktion"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value
             value="4.5 Interacties met andere geneesmiddelen en andere vormen van interactie"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="4.5 Koostoimed teiste ravimitega ja muud koostoimed"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value
             value="4.5 Yhteisvaikutukset muiden lääkevalmisteiden kanssa sekä muut yhteisvaikutukset"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value
             value="4.5 Interactions avec d’autres médicaments et autres formes d’interactions"/>
    </designation>
    <designation>
      <language value="de"/>
      <value
             value="4.5 Wechselwirkungen mit anderen Arzneimitteln und sonstige Wechselwirkungen"/>
    </designation>
    <designation>
      <language value="el"/>
      <value
             value="4.5 Αλληλεπιδράσεις με άλλα φαρμακευτικά προϊόντα και άλλες μορφές αλληλεπίδρασης"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="4.5 Gyógyszerkölcsönhatások és egyéb interakciók"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="4.5 Milliverkanir við önnur lyf og aðrar milliverkanir"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value
             value="4.5 Idirghníomhaíocht le táirgí íocshláinte eile agus cineálacha eile idirghníomhaíochta"/>
    </designation>
    <designation>
      <language value="it"/>
      <value
             value="4.5 Interazioni con altri medicinali ed altre forme d’interazione"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value
             value="4.5. Mijiedarbība ar citām zālēm un citi mijiedarbības veidi"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value
             value="4.5 Sąveika su kitais vaistiniais preparatais ir kitokia sąveika"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value
             value="4.5 Interazzjoni ma’ prodotti mediċinali oħra u forom oħra ta’ interazzjoni"/>
    </designation>
    <designation>
      <language value="no"/>
      <value
             value="4.5 Interaksjon med andre legemidler og andre former for interaksjon"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value
             value="4.5 Interakcje z innymi produktami leczniczymi i inne rodzaje interakcji"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value
             value="4.5 Interações medicamentosas e outras formas de interação"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value
             value="4.5 Interacțiuni cu alte medicamente și alte forme de interacțiune"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="4.5 Liekové a iné interakcie"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value
             value="4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij"/>
    </designation>
    <designation>
      <language value="es"/>
      <value
             value="4.5 Interacción con otros medicamentos y otras formas de interacción"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value
             value="4.5 Interaktioner med andra läkemedel och övriga interaktioner"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029810"/>
    <display value="Paediatric population"/>
    <designation>
      <language value="en"/>
      <value value="Paediatric population"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Педиатрична популация"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Pedijatrijska populacija"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Pediatrická populace"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Pædiatrisk population"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Pediatrische patiënten"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Lapsed"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Pediatriset potilaat"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Population pédiatrique"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Kinder und Jugendliche"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Παιδιατρικός πληθυσμός"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Gyermekek és serdülők"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Börn"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Daonra péidiatrach"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Popolazione pediatrica"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Pediatriskā populācija"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Vaikų populiacija"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Popolazzjoni pedjatrika"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Pediatrisk populasjon"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Dzieci i młodzież"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="População pediátrica"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Copii și adolescenți"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Pediatrická populácia"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Pediatrična populacija"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Población pediátrica"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Pediatrisk population"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029811"/>
    <display value="4.6 Fertility, pregnancy and lactation"/>
    <designation>
      <language value="en"/>
      <value value="4.6 Fertility, pregnancy and lactation"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="4.6 Фертилитет, бременност и кърмене"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="4.6 Plodnost, trudnoća i dojenje"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="4.6 Fertilita, těhotenství a kojení"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="4.6 Fertilitet, graviditet og amning"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="4.6 Vruchtbaarheid, zwangerschap en borstvoeding"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="4.6 Fertiilsus, rasedus ja imetamine"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="4.6 Hedelmällisyys, raskaus ja imetys"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="4.6 Fertilité, grossesse et allaitement"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="4.6 Fertilität, Schwangerschaft und Stillzeit"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="4.6 Γονιμότητα, κύηση και γαλουχία"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="4.6 Termékenység, terhesség és szoptatás"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="4.6 Frjósemi, meðganga og brjóstagjöf"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="4.6 Torthúlacht, toircheas agus lachtadh"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="4.6 Fertilità, gravidanza e allattamento"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="4.6. Fertilitāte, grūtniecība un barošana ar krūti"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="4.6 Vaisingumas, nėštumo ir žindymo laikotarpis"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="4.6 Fertilità, tqala u treddigħ"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="4.6 Fertilitet, graviditet og amming"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="4.6 Wpływ na płodność, ciążę i laktację"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="4.6 Fertilidade, gravidez e aleitamento"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="4.6 Fertilitatea, sarcina și alăptarea"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="4.6 Fertilita, gravidita a laktácia"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="4.6 Plodnost, nosečnost in dojenje"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="4.6 Fertilidad, embarazo y lactancia"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="4.6 Fertilitet, graviditet och amning"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029812"/>
    <display value="Pregnancy"/>
    <designation>
      <language value="en"/>
      <value value="Pregnancy"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Бременност"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Trudnoća"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Těhotenství"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Graviditet"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Zwangerschap"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Rasedus"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Raskaus"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Grossesse"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Schwangerschaft"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Κύηση"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Terhesség"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Meðganga"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Toircheas"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Gravidanza"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Grūtniecība"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Nėštumas"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Tqala"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Graviditet"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Ciąża"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Gravidez"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Sarcina"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Gravidita"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Nosečnost"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Embarazo"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Graviditet"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029813"/>
    <display value="Breast-feeding"/>
    <designation>
      <language value="en"/>
      <value value="Breast-feeding"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Кърмене"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Dojenje"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Kojení"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Amning"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Borstvoeding"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Imetamine"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Imetys"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Allaitement"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Stillzeit"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Θηλασμός"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Szoptatás"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Brjóstagjöf"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Beathú cíche"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Allattamento"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Barošana ar krūti"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Žindymas"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Treddigħ"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Amming"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Karmienie piersią"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Amamentação"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Alăptarea"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Dojčenie"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Dojenje"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Lactancia"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Amning"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029814"/>
    <display value="Fertility"/>
    <designation>
      <language value="en"/>
      <value value="Fertility"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Фертилитет"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Plodnost"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Fertilita"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Fertilitet"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Vruchtbaarheid"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Fertiilsus"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Hedelmällisyys"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Fertilité"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Fertilität"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Γονιμότητα"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Termékenység"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Frjósemi"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Torthúlacht"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Fertilità"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Fertilitāte"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Vaisingumas"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Fertilità"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Fertilitet"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Płodność"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Fertilidade"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Fertilitatea"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Fertilita"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Plodnost"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Fertilidad"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Fertilitet"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029815"/>
    <display value="4.7 Effects on ability to drive and use machines"/>
    <designation>
      <language value="en"/>
      <value value="4.7 Effects on ability to drive and use machines"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value
             value="4.7 Ефекти върху способността за шофиране и работа с машини"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value
             value="4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="4.7 Účinky na schopnost řídit a obsluhovat stroje"/>
    </designation>
    <designation>
      <language value="da"/>
      <value
             value="4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value
             value="4.7 Beïnvloeding van de rijvaardigheid en het vermogen om machines te bedienen"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="4.7 Toime reaktsioonikiirusele"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="4.7 Vaikutus ajokykyyn ja koneidenkäyttökykyyn"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value
             value="4.7 Effets sur l’aptitude à conduire des véhicules et à utiliser des machines"/>
    </designation>
    <designation>
      <language value="de"/>
      <value
             value="4.7 Auswirkungen auf die Verkehrstüchtigkeit und die Fähigkeit zum Bedienen von Maschinen"/>
    </designation>
    <designation>
      <language value="el"/>
      <value
             value="4.7 Επιδράσεις στην ικανότητα οδήγησης και χειρισμού μηχανημάτων"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value
             value="4.7 A készítmény hatásai a gépjárművezetéshez és a gépek kezeléséhez szükséges képességekre"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="4.7 Áhrif á hæfni til aksturs og notkunar véla"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="4.7 Éifeachtaí ar an gcumas tiomána agus úsáide inneall"/>
    </designation>
    <designation>
      <language value="it"/>
      <value
             value="4.7 Effetti sulla capacità di guidare veicoli e sull’uso di macchinari"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value
             value="4.7. Ietekme uz spēju vadīt transportlīdzekļus un apkalpot mehānismus"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="4.7 Poveikis gebėjimui vairuoti ir valdyti mechanizmus"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="4.7 Effetti fuq il-ħila biex issuq u tħaddem magni"/>
    </designation>
    <designation>
      <language value="no"/>
      <value
             value="4.7 Påvirkning av evnen til å kjøre bil og bruke maskiner"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value
             value="4.7 Wpływ na zdolność prowadzenia pojazdów i obsługiwania maszyn"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value
             value="4.7 Efeitos sobre a capacidade de conduzir e utilizar máquinas"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value
             value="4.7 Efecte asupra capacității de a conduce vehicule și de a folosi utilaje"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value
             value="4.7 Ovplyvnenie schopnosti viesť vozidlá a obsluhovať stroje"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="4.7 Vpliv na sposobnost vožnje in upravljanja strojev"/>
    </designation>
    <designation>
      <language value="es"/>
      <value
             value="4.7 Efectos sobre la capacidad para conducir y utilizar máquinas"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value
             value="4.7 Effekter på förmågan att framföra fordon och använda maskiner"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029816"/>
    <display value="4.8 Undesirable effects"/>
    <designation>
      <language value="en"/>
      <value value="4.8 Undesirable effects"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="4.8 Нежелани лекарствени реакции"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="4.8 Nuspojave"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="4.8 Nežádoucí účinky"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="4.8 Bivirkninger"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="4.8 Bijwerkingen"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="4.8 Kõrvaltoimed"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="4.8 Haittavaikutukset"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="4.8 Effets indésirables"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="4.8 Nebenwirkungen"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="4.8 Ανεπιθύμητες ενέργειες"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="4.8 Nemkívánatos hatások, mellékhatások"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="4.8 Aukaverkanir"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="4.8 Éifeachtaí neamh-inmhianaithe"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="4.8 Effetti indesiderati"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="4.8. Nevēlamās blakusparādības"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="4.8 Nepageidaujamas poveikis"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="4.8 Effetti mhux mixtieqa"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="4.8 Bivirkninger"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="4.8 Działania niepożądane"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="4.8 Efeitos indesejáveis"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="4.8 Reacții adverse"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="4.8 Nežiaduce účinky"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="4.8 Neželeni učinki"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="4.8 Reacciones adversas"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="4.8 Biverkningar"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029817"/>
    <display value="Paediatric population"/>
    <designation>
      <language value="en"/>
      <value value="Paediatric population"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Педиатрична популация"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Pedijatrijska populacija"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Pediatrická populace"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Pædiatrisk population"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Pediatrische patiënten"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Lapsed"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Pediatriset potilaat"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Population pédiatrique"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Kinder und Jugendliche"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Παιδιατρικός πληθυσμός"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Gyermekek és serdülők"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Börn"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Daonra péidiatrach"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Popolazione pediatrica"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Pediatriskā populācija"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Vaikų populiacija"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Popolazzjoni pedjatrika"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Pediatrisk populasjon"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Dzieci i młodzież"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="População pediátrica"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Copii și adolescenți"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Pediatrická populácia"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Pediatrična populacija"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Población pediátrica"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Pediatrisk population"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029818"/>
    <display value="Reporting of suspected adverse reactions"/>
    <designation>
      <language value="en"/>
      <value value="Reporting of suspected adverse reactions"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Съобщаване на подозирани нежелани реакции"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Prijavljivanje sumnji na nuspojavu"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Hlášení podezření na nežádoucí účinky"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Indberetning af formodede bivirkninger"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Melding van vermoedelijke bijwerkingen"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Võimalikest kõrvaltoimetest teatamine"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Epäillyistä haittavaikutuksista ilmoittaminen"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Déclaration des effets indésirables suspectés"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Meldung des Verdachts auf Nebenwirkungen"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Αναφορά πιθανολογούμενων ανεπιθύμητων ενεργειών"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Feltételezett mellékhatások bejelentése"/>
    </designation>
    <designation>
      <language value="is"/>
      <value
             value="Tilkynning aukaverkana sem grunur er um að tengist lyfinu"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Tuairisciú ar fhrithghníomhartha díobhálacha amhrasta"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Segnalazione delle reazioni avverse sospette"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Ziņošana par iespējamām nevēlamām blakusparādībām"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Pranešimas apie įtariamas nepageidaujamas reakcijas"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Rappurtar ta’ reazzjonijiet avversi suspettati"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Melding av mistenkte bivirkninger"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Zgłaszanie podejrzewanych działań niepożądanych"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Notificação de suspeitas de reações adversas"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Raportarea reacțiilor adverse suspectate"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Hlásenie podozrení na nežiaduce reakcie"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Poročanje o domnevnih neželenih učinkih"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Notificación de sospechas de reacciones adversas"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Rapportering av misstänkta biverkningar"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029819"/>
    <display value="4.9 Overdose"/>
    <designation>
      <language value="en"/>
      <value value="4.9 Overdose"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="4.9 Предозиране"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="4.9 Predoziranje"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="4.9 Předávkování"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="4.9 Overdosering"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="4.9 Overdosering"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="4.9 Üleannustamine"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="4.9 Yliannostus"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="4.9 Surdosage"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="4.9 Überdosierung"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="4.9 Υπερδοσολογία"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="4.9 Túladagolás"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="4.9 Ofskömmtun"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="4.9 Ródháileog"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="4.9 Sovradosaggio"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="4.9. Pārdozēšana"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="4.9 Perdozavimas"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="4.9 Doża eċċessiva"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="4.9 Overdosering"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="4.9 Przedawkowanie"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="4.9 Sobredosagem"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="4.9 Supradozaj"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="4.9 Predávkovanie"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="4.9 Preveliko odmerjanje"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="4.9 Sobredosis"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="4.9 Överdosering"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029820"/>
    <display value="Paediatric population"/>
    <designation>
      <language value="en"/>
      <value value="Paediatric population"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Педиатрична популация"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Pedijatrijska populacija"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Pediatrická populace"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Pædiatrisk population"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Pediatrische patiënten"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Lapsed"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Pediatriset potilaat"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Population pédiatrique"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Kinder und Jugendliche"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Παιδιατρικός πληθυσμός"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Gyermekek és serdülők"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Börn"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Daonra péidiatrach"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Popolazione pediatrica"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Pediatriskā populācija"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Vaikų populiacija"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Popolazzjoni pedjatrika"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Pediatrisk populasjon"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Dzieci i młodzież"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="População pediátrica"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Copii și adolescenți"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Pediatrická populácia"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Pediatrična populacija"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Población pediátrica"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Pediatrisk population"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029821"/>
    <display value="5. PHARMACOLOGICAL PROPERTIES"/>
    <designation>
      <language value="en"/>
      <value value="5. PHARMACOLOGICAL PROPERTIES"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="5. ФАРМАКОЛОГИЧНИ СВОЙСТВА"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="5. FARMAKOLOŠKA SVOJSTVA"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="5. FARMAKOLOGICKÉ VLASTNOSTI"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="5. FARMAKOLOGISKE EGENSKABER"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="5. FARMACOLOGISCHE EIGENSCHAPPEN"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="5. FARMAKOLOOGILISED OMADUSED"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="5. FARMAKOLOGISET OMINAISUUDET"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="5. PROPRIÉTÉS PHARMACOLOGIQUES"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="5. PHARMAKOLOGISCHE EIGENSCHAFTEN"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="5. ΦΑΡΜΑΚΟΛΟΓΙΚΕΣ ΙΔΙΟΤΗΤΕΣ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="5. FARMAKOLÓGIAI TULAJDONSÁGOK"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="5. LYFJAFRÆÐILEGAR UPPLÝSINGAR"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="5. AIRÍONNA CÓGASEOLAÍOCHA"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="5. PROPRIETÀ FARMACOLOGICHE"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="5. FARMAKOLOĢISKĀS ĪPAŠĪBAS"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="5. FARMAKOLOGINĖS SAVYBĖS"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="5. PROPRJETAJIET FARMAKOLOĠIĊI"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="5. FARMAKOLOGISKE EGENSKAPER"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="5. WŁAŚCIWOŚCI FARMAKOLOGICZNE"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="5. PROPRIEDADES FARMACOLÓGICAS"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="5. PROPRIETĂȚI FARMACOLOGICE"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="5. FARMAKOLOGICKÉ VLASTNOSTI"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="5. FARMAKOLOŠKE LASTNOSTI"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="5. PROPIEDADES FARMACOLÓGICAS"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="5. FARMAKOLOGISKA EGENSKAPER"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029822"/>
    <display value="5.1 Pharmacodynamic properties"/>
    <designation>
      <language value="en"/>
      <value value="5.1 Pharmacodynamic properties"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="5.1 Фармакодинамични свойства"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="5.1 Farmakodinamička svojstva"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="5.1 Farmakodynamické vlastnosti"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="5.1 Farmakodynamiske egenskaber"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="5.1 Farmacodynamische eigenschappen"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="5.1 Farmakodünaamilised omadused"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="5.1 Farmakodynamiikka"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="5.1 Propriétés pharmacodynamiques"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="5.1 Pharmakodynamische Eigenschaften"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="5.1 Φαρμακοδυναμικές ιδιότητες"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="5.1 Farmakodinámiás tulajdonságok"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="5.1 Lyfhrif"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="5.1 Airíonna cógasdinimiciúla"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="5.1 Proprietà farmacodinamiche"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="5.1. Farmakodinamiskās īpašības"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="5.1 Farmakodinaminės savybės"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="5.1 Proprjetajiet farmakodinamiċi"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="5.1 Farmakodynamiske egenskaper"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="5.1 Właściwości farmakodynamiczne"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="5.1 Propriedades farmacodinâmicas"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="5.1 Proprietăți farmacodinamice"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="5.1 Farmakodynamické vlastnosti"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="5.1 Farmakodinamične lastnosti"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="5.1 Propiedades farmacodinámicas"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="5.1 Farmakodynamiska egenskaper"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029823"/>
    <display value="Mechanism of action"/>
    <designation>
      <language value="en"/>
      <value value="Mechanism of action"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Механизъм на действие"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Mehanizam djelovanja"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Mechanismus účinku"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Virkningsmekanisme"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Werkingsmechanisme"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Toimemehhanism"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Vaikutusmekanismi"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Mécanisme d’action"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Wirkmechanismus"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Μηχανισμός δράσης"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Hatásmechanizmus"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Verkunarháttur"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Meicníocht gníomhaíochta"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Meccanismo d’azione"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Darbības mehānisms"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Veikimo mechanizmas"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Mekkaniżmu ta’ azzjoni"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Virkningsmekanisme"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Mechanizm działania"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Mecanismo de ação"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Mecanism de acțiune"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Mechanizmus účinku"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Mehanizem delovanja"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Mecanismo de acción"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Verkningsmekanism"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029824"/>
    <display value="Pharmacodynamic effects"/>
    <designation>
      <language value="en"/>
      <value value="Pharmacodynamic effects"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Фармакодинамични ефекти"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Farmakodinamički učinci"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Farmakodynamické účinky"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Farmakodynamisk virkning"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Farmacodynamische effecten"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Farmakodünaamilised toimed"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Farmakodynaamiset vaikutukset"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Effets pharmacodynamiques"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Pharmakodynamische Wirkungen"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Φαρμακοδυναμικές επιδράσεις"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Farmakodinámiás hatások"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Lyfhrif"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Éifeachtaí cógasdinimiciúla"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Effetti farmacodinamici"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Farmakodinamiskā iedarbība"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Farmakodinaminis poveikis"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Effetti farmakodinamiċi"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Farmakodynamiske effekter"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Działanie farmakodynamiczne"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Efeitos farmacodinâmicos"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Efecte farmacodinamice"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Farmakodynamické účinky"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Farmakodinamični učinki"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Efectos farmacodinámicos"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Farmakodynamisk effekt"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029825"/>
    <display value="Clinical efficacy and safety"/>
    <designation>
      <language value="en"/>
      <value value="Clinical efficacy and safety"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Клинична ефикасност и безопасност"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Klinička djelotvornost i sigurnost"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Klinická účinnost a bezpečnost"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Klinisk virkning og sikkerhed"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Klinische werkzaamheid en veiligheid"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Kliiniline efektiivsus ja ohutus"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Kliininen teho ja turvallisuus"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Efficacité et sécurité cliniques"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Klinische Wirksamkeit und Sicherheit"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Κλινική αποτελεσματικότητα και ασφάλεια"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Klinikai hatásosság és biztonságosság"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Verkun og öryggi"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Éifeachtúlacht chliniciúil agus sábháilteacht"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Efficacia e sicurezza clinica"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Klīniskā efektivitāte un drošums"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Klinikinis veiksmingumas ir saugumas"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Effikaċja klinika u sigurtà"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Klinisk effekt og sikkerhet"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Skuteczność kliniczna i bezpieczeństwo stosowania"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Eficácia e segurança clínicas"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Eficacitate și siguranță clinică"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Klinická účinnosť a bezpečnosť"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Klinična učinkovitost in varnost"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Eficacia clínica y seguridad"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Klinisk effekt och säkerhet"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029826"/>
    <display value="Paediatric population"/>
    <designation>
      <language value="en"/>
      <value value="Paediatric population"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Педиатрична популация"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Pedijatrijska populacija"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Pediatrická populace"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Pædiatrisk population"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Pediatrische patiënten"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Lapsed"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Pediatriset potilaat"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Population pédiatrique"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Kinder und Jugendliche"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Παιδιατρικός πληθυσμός"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Gyermekek és serdülők"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Börn"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Daonra péidiatrach"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Popolazione pediatrica"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Pediatriskā populācija"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Vaikų populiacija"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Popolazzjoni pedjatrika"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Pediatrisk populasjon"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Dzieci i młodzież"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="População pediátrica"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Copii și adolescenți"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Pediatrická populácia"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Pediatrična populacija"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Población pediátrica"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Pediatrisk population"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029827"/>
    <display value="5.2 Pharmacokinetic properties"/>
    <designation>
      <language value="en"/>
      <value value="5.2 Pharmacokinetic properties"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="5.2 Фармакокинетични свойства"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="5.2 Farmakokinetička svojstva"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="5.2 Farmakokinetické vlastnosti"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="5.2 Farmakokinetiske egenskaber"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="5.2 Farmacokinetische eigenschappen"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="5.2 Farmakokineetilised omadused"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="5.2 Farmakokinetiikka"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="5.2 Propriétés pharmacocinétiques"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="5.2 Pharmakokinetische Eigenschaften"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="5.2 Φαρμακοκινητικές ιδιότητες"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="5.2 Farmakokinetikai tulajdonságok"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="5.2 Lyfjahvörf"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="5.2 Airíonna cógaschinéiteacha"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="5.2 Proprietà farmacocinetiche"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="5.2. Farmakokinētiskās īpašības"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="5.2 Farmakokinetinės savybėsv"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="5.2 Tagħrif farmakokinetiku"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="5.2 Farmakokinetiske egenskaper"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="5.2 Właściwości farmakokinetyczne"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="5.2 Propriedades farmacocinéticas"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="5.2 Proprietăți farmacocinetice"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="5.2 Farmakokinetické vlastnosti"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="5.2 Farmakokinetične lastnosti"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="5.2 Propiedades farmacocinéticas"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="5.2 Farmakokinetiska egenskaper"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029828"/>
    <display value="Absorption"/>
    <designation>
      <language value="en"/>
      <value value="Absorption"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Абсорбция"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Apsorpcija"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Absorpce"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Absorption"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Absorptie"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Imendumine"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Imeytyminen"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Absorption"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Resorption"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Απορρόφηση"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Felszívódás"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Frásog"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Ionsú"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Assorbimento"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Uzsūkšanā"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Absorbcija"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Assorbiment"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Absorpsjon"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Wchłanianie"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Absorção"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Absorbție"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Absorpcia"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Absorpcija"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Absorción"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Absorption"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029829"/>
    <display value="Distribution"/>
    <designation>
      <language value="en"/>
      <value value="Distribution"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Разпределение"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Distribucija"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Distribuce"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Fordeling"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Distributie"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Jaotumine"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Jakautuminen"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Distribution"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Verteilung"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Κατανομή"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Eloszlás"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Dreifing"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Dáileachán"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Distribuzione"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Izkliede"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Pasiskirstymas"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Distribuzzjoni"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Distribusjon"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Dystrybucja"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Distribuição"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Distribuție"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Distribúcia"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Porazdelitev"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Distribución"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Distribution"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029830"/>
    <display value="Biotransformation"/>
    <designation>
      <language value="en"/>
      <value value="Biotransformation"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Биотрансформация"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Biotransformacija"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Biotransformace"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Biotransformation"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Biotransformatie"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Biotransformatsioon"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Biotransformaatio"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Biotransformation"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Biotransformation"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Βιομετασχηματισμός"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Biotranszformáció"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Umbrot"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Bithchlaochlú"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Biotrasformazione"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Biotransformācija"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Biotransformacija"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Bijotrasformazzjoni"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Biotransformasjon"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Metabolizm"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Biotransformação"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Metabolizare"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Biotransformácia"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Biotransformacija"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Biotransformación"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Metabolism"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029831"/>
    <display value="Elimination"/>
    <designation>
      <language value="en"/>
      <value value="Elimination"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Елиминиране"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Eliminacija"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Eliminace"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Elimination"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Eliminatie"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Eritumine"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Eliminaatio"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Élimination"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Elimination"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Αποβολή"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Elimináció"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Brotthvarf"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Díbirt"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Eliminazione"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Eliminācija"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Eliminacija"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Eliminazzjoni"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Eliminasjon"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Eliminacja"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Eliminação"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Eliminare"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Eliminácia"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Izločanje"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Eliminación"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Eliminering"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029832"/>
    <display value="Linearity/non-linearity"/>
    <designation>
      <language value="en"/>
      <value value="Linearity/non-linearity"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Линейност/нелинейност"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Linearnost/nelinearnost"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Linearita/nelinearita"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Linearitet/non-linearitet"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Lineariteit/non-lineariteit"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Lineaarsus/mittelineaarsus"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Lineaarisuus/ei-lineaarisuus"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Linéarité/non-linéarité"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Linearität/Nicht-Linearität"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Γραμμικότητα/μη γραμμικότητα"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Linearitás/nonlinearitás"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Línulegt/ólínulegt samband"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Líneacht/neamhlíneacht"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Linearità/Non linearità"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Linearitāte/nelinearitāte"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Tiesinis / netiesinis pobūdis"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Linearità/nuqqas ta’ linearità"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Linearitet/ikke-linearitet"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Liniowość lub nieliniowość"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Linearidade/não linearidade"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Liniaritate/Non-liniaritate"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Linearita/nelinearita"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Linearnost/nelinearnost"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Linealidad/No linealidad"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Linjäritet/icke-linjäritet"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029833"/>
    <display value="Pharmacokinetic/pharmacodynamic relationship(s)"/>
    <designation>
      <language value="en"/>
      <value value="Pharmacokinetic/pharmacodynamic relationship(s)"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Връзка(и) фармакокинетика-фармакодинамика"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Farmakokinetički/farmakodinamički odnos(i)"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Farmakokinetické/farmakodynamické vztahy"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Farmakokinetiske/farmakodynamiske forhold"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Farmacokinetische/farmacodynamische relatie(s)"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Farmakokineetilised/farmakodünaamilised toimed"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Farmakokineettiset/farmakodynaamiset suhteet"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Relations pharmacocinétique/pharmacodynamique"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Pharmakokinetische/pharmakodynamische Zusammenhänge"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Φαρμακοκινητικές/φαρμακοδυναμικές σχέσεις"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Farmakokinetikai/farmakodinámiás összefüggés(ek)"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Tengsl lyfjahvarfa og lyfhrifa"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Caidreamh cógaschinéiteach/cógasdinimiciúil"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Relazione(i) farmacocinetica(che)/farmacodinamica(che)"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Farmakokinētiskā(-s)/farmakodinamiskā(-s) attiecība(-s)"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Santykis tarp farmakokinetikos ir farmakodinamikos"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value
             value="Relazzjoni(-jiet) farmakokinetika(ċi)/farmakodinamika(ċi)"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Farmakokinetiske/farmakodynamiske forhold"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Zależności farmakokinetyczno-farmakodynamiczne"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Relação(ões) farmacocinética/farmacodinâmica"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Relație(i) farmacocinetică(e)/farmacodinamică(e)"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Farmakokinetický/farmakodynamický vzťah"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Farmakokinetično/farmakodinamično razmerje"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Relación(es) farmacocinéticas/farmacodinámica(s)"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value
             value="Farmakokinetiskt (Farmakokinetiska)/farmakodynamiskt (farmakodynamiska) förhållande(n)"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029834"/>
    <display value="5.3 Preclinical safety data"/>
    <designation>
      <language value="en"/>
      <value value="5.3 Preclinical safety data"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="5.3 Предклинични данни за безопасност"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="5.3 Neklinički podaci o sigurnosti primjene"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="5.3 Předklinické údaje vztahující se k bezpečnosti"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="5.3 Non-kliniske sikkerhedsdata"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="5.3 Gegevens uit het preklinisch veiligheidsonderzoek"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="5.3 Prekliinilised ohutusandmedv"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="5.3 Prekliiniset tiedot turvallisuudesta"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="5.3 Données de sécurité préclinique"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="5.3 Präklinische Daten zur Sicherheit"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="5.3 Προκλινικά δεδομένα για την ασφάλεια"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value
             value="5.3 A preklinikai biztonságossági vizsgálatok eredményei"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="5.3 Forklínískar upplýsingar"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="5.3 Sonraí sábháilteachta réamhchliniciúla"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="5.3 Dati preclinici di sicurezza"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="5.3. Preklīniskie dati par drošumu"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="5.3 Ikiklinikinių saugumo tyrimų duomenys"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="5.3 Tagħrif ta' qabel l-użu kliniku dwar is-sigurtà"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="5.3 Prekliniske sikkerhetsdata"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="5.3 Przedkliniczne dane o bezpieczeństwie"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="5.3 Dados de segurança pré-clínica"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="5.3 Date preclinice de siguranță"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="5.3 Predklinické údaje o bezpečnosti"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="5.3 Predklinični podatki o varnosti"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="5.3 Datos preclínicos sobre seguridad"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="5.3 Prekliniska säkerhetsuppgifter"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029835"/>
    <display value="Environmental risk assessment (ERA)"/>
    <designation>
      <language value="en"/>
      <value value="Environmental risk assessment (ERA)"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Оценка на риска за околната среда (ERA)"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Procjena rizika za okoliš (ERA)"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Posouzení rizika pro životní prostředí"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Miljørisikovurdering"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Environmental Risk Assessment (ERA)"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Keskkonnariski hindamine"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Ympäristöön kohdistuvien riskien arviointi"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Évaluation du risque environnemental"/>
    </designation>
    <designation>
      <language value="de"/>
      <value
             value="Beurteilung der Risiken für die Umwelt (Environmental risk assessment [ERA])"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Αξιολόγηση περιβαλλοντικού κινδύνου"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Becsült környezeti kockázat"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Mat á áhættu fyrir lífríkið"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Measúnú riosca don chomhshaoil (MRC)"/>
    </designation>
    <designation>
      <language value="it"/>
      <value
             value="Valutazione del rischio ambientale (Environmental risk assessment, ERA)"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Vides riska novērtējums (VRN)"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Pavojaus aplinkai vertinimas (PAV)"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Valutazzjoni tar-riskju ambjentali (ERA)"/>
    </designation>
    <designation>
      <language value="no"/>
      <value
             value="Evaluering av miljørisiko (Environmental risk assessment, ERA)"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Ocena ryzyka dla środowiska"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Avaliação do risco ambiental (ARA)"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Evaluarea riscului de mediu (ERM)"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Hodnotenie environmentálneho rizika (ERA)"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Ocena tveganja za okolje"/>
    </designation>
    <designation>
      <language value="es"/>
      <value
             value="Evaluación del riesgo medioambiental (ERA, por sus siglas en inglés)"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Miljöriskbedömning"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029836"/>
    <display value="6. PHARMACEUTICAL PARTICULARS"/>
    <designation>
      <language value="en"/>
      <value value="6. PHARMACEUTICAL PARTICULARS"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="6. ФАРМАЦЕВТИЧНИ ДАННИ"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="6. FARMACEUTSKI PODACI"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="6. FARMACEUTICKÉ ÚDAJE"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="6. FARMACEUTISKE OPLYSNINGER"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="6. FARMACEUTISCHE GEGEVENS"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="6. FARMATSEUTILISED ANDMED"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="6. FARMASEUTTISET TIEDOT"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="6. DONNÉES PHARMACEUTIQUES"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="6. PHARMAZEUTISCHE ANGABEN"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="6. ΦΑΡΜΑΚΕΥΤΙΚΕΣ ΠΛΗΡΟΦΟΡΙΕΣ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="6. GYÓGYSZERÉSZETI JELLEMZŐK"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="6. LYFJAGERÐARFRÆÐILEGAR UPPLÝSINGAR"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="6. SONRAÍ CÓGAISÍOCHTA"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="6. INFORMAZIONI FARMACEUTICHE"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="6. FARMACEITISKĀ INFORMĀCIJA"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="6. FARMACINĖ INFORMACIJA"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="6. TAGĦRIF FARMAĊEWTIKU"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="6. FARMASØYTISKE OPPLYSNINGER"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="6. DANE FARMACEUTYCZNE"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="6. INFORMAÇÕES FARMACÊUTICAS"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="6. PROPRIETĂȚI FARMACEUTICE"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="6. FARMACEUTICKÉ INFORMÁCIE"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="6. FARMACEVTSKI PODATKI"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="6. DATOS FARMACÉUTICOS"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="6. FARMACEUTISKA UPPGIFTER"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029837"/>
    <display value="6.1 List of excipients"/>
    <designation>
      <language value="en"/>
      <value value="6.1 List of excipients"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="6.1 Списък на помощните вещества"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="6.1 Popis pomoćnih tvari"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="6.1 Seznam pomocných látek"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="6.1 Hjælpestoffer"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="6.1 Lijst van hulpstoffen"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="6.1 Abiainete loetelu"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="6.1 Apuaineet"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="6.1 Liste des excipients"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="6.1 Liste der sonstigen Bestandteile"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="6.1 Κατάλογος εκδόχων"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="6.1 Segédanyagok felsorolása"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="6.1 Hjálparefni"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="6.1 Liosta de na támháin"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="6.1 Elenco degli eccipienti"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="6.1. Palīgvielu saraksts"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="6.1 Pagalbinių medžiagų sąrašas"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="6.1 Lista ta’ eċċipjenti"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="6.1 Hjelpestoffer"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="6.1 Wykaz substancji pomocniczych"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="6.1 Lista dos excipientes"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="6.1 Lista excipienților"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="6.1 Zoznam pomocných látok"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="6.1 Seznam pomožnih snovi"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="6.1 Lista de excipientes"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="6.1 Förteckning över hjälpämnen"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029838"/>
    <display value="6.2 Incompatibilities"/>
    <designation>
      <language value="en"/>
      <value value="6.2 Incompatibilities"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="6.2 Несъвместимости"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="6.2 Inkompatibilnosti"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="6.2 Inkompatibility"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="6.2 Uforligeligheder"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="6.2 Gevallen van onverenigbaarheid"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="6.2 Sobimatus"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="6.2 Yhteensopimattomuudet"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="6.2 Incompatibilités"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="6.2 Inkompatibilitäten"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="6.2 Ασυμβατότητες"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="6.2 Inkompatibilitások"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="6.2 Ósamrýmanleiki"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="6.2 Neamh-chomhoiriúnachtaí"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="6.2 Incompatibilità"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="6.2. Nesaderība"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="6.2 Nesuderinamumas"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="6.2 Inkompatibbiltajiet"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="6.2 Uforlikeligheter"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="6.2 Niezgodności farmaceutyczne"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="6.2 Incompatibilidades"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="6.2 Incompatibilități"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="6.2 Inkompatibility"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="6.2 Inkompatibilnosti"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="6.2 Incompatibilidades"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="6.2 Inkompatibiliteter"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029839"/>
    <display value="6.3 Shelf life"/>
    <designation>
      <language value="en"/>
      <value value="6.3 Shelf life"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="6.3 Срок на годност"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="6.3 Rok valjanosti"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="6.3 Doba použitelnosti"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="6.3 Opbevaringstid"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="6.3 Houdbaarheid"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="6.3 Kõlblikkusaeg"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="6.3 Kestoaika"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="6.3 Durée de conservation"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="6.3 Dauer der Haltbarkeit"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="6.3 Διάρκεια ζωής"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="6.3 Felhasználhatósági időtartam"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="6.3 Geymsluþol"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="6.3 Seilfré"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="6.3 Periodo di validità"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="6.3. Uzglabāšanas laiks"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="6.3 Tinkamumo laikas"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="6.3 Żmien kemm idum tajjeb il-prodott mediċinali"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="6.3 Holdbarhet"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="6.3 Okres ważności"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="6.3 Prazo de validade"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="6.3 Perioada de valabilitate"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="6.3 Čas použiteľnosti"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="6.3 Rok uporabnosti"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="6.3 Periodo de validez"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="6.3 Hållbarhet"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029840"/>
    <display value="6.4 Special precautions for storage"/>
    <designation>
      <language value="en"/>
      <value value="6.4 Special precautions for storage"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="6.4 Специални условия на съхранение"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="6.4 Posebne mjere pri čuvanju lijeka"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="6.4 Zvláštní opatření pro uchovávání"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="6.4 Særlige opbevaringsforhold"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="6.4 Speciale voorzorgsmaatregelen bij bewaren"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="6.4 Säilitamise eritingimused"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="6.4 Säilytys"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="6.4 Précautions particulières de conservation"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="6.4 Besondere Vorsichtsmaßnahmen für die Aufbewahrung"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="6.4 Ιδιαίτερες προφυλάξεις κατά τη φύλαξη του προϊόντος"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="6.4 Különleges tárolási előírások"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="6.4 Sérstakar varúðarreglur við geymslu"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="6.4 Réamhchúraimí stórála ar leith"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="6.4 Precauzioni particolari per la conservazione"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="6.4. Īpaši uzglabāšanas nosacījumi"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="6.4 Specialios laikymo sąlygos"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="6.4 Prekawzjonijiet speċjali għall-ħażna"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="6.4 Oppbevaringsbetingelser"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="6.4 Specjalne środki ostrożności podczas przechowywania"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="6.4 Precauções especiais de conservação"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="6.4 Precauții speciale pentru păstrare"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="6.4 Špeciálne upozornenia na uchovávanie"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="6.4 Posebna navodila za shranjevanje"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="6.4 Precauciones especiales de conservación"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="6.4 Särskilda förvaringsanvisningar"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029841"/>
    <display
             value="6.5 Nature and contents of container [and special equipment for use, administration or implantation]"/>
    <designation>
      <language value="en"/>
      <value
             value="6.5 Nature and contents of container [and special equipment for use, administration or implantation]"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value
             value="6.5 Вид и съдържание на опаковката [и специални приспособления за употреба, приложение или имплантиране]"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value
             value="6.5 Vrsta i sadržaj spremnika [i posebna oprema za uporabu, primjenu ili ugradnju]"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value
             value="6.5 Druh obalu a obsah balení [a zvláštní vybavení pro použití, podání nebo implantaci]"/>
    </designation>
    <designation>
      <language value="da"/>
      <value
             value="6.5 Emballagetype og pakningsstørrelser [og specielt udstyr til anvendelse, administration eller implantation]"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value
             value="6.5 Aard en inhoud van de verpakking [en speciale benodigdheden voor gebruik, toediening of implantatie]"/>
    </designation>
    <designation>
      <language value="et"/>
      <value
             value="6.5 Pakendi iseloomustus ja sisu [ja kasutamise, manustamise või implanteerimise erivahendid]"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value
             value="6.5 Pakkaustyyppi ja pakkauskoko (pakkauskoot) [sekä erityiset välineet lääkkeen käyttöä, antoa tai paikalleen asettamista varten]"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value
             value="6.5 Nature et contenu de l’emballage extérieur [et équipement spécial pour l’utilisation, l’administration ou la greffe]"/>
    </designation>
    <designation>
      <language value="de"/>
      <value
             value="6.5 Art und Inhalt des Behältnisses [und spezielles Zubehör für den Gebrauch, die Anwendung oder die Implantation]"/>
    </designation>
    <designation>
      <language value="el"/>
      <value
             value="6.5 Φύση και συστατικά του περιέκτη [και ειδικός εξοπλισμός για τη χρήση, τη χορήγηση ή την εμφύτευση]"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value
             value="6.5 Csomagolás típusa és kiszerelése [, valamint speciális eszköz(ök) a használathoz, alkalmazáshoz vagy az implantációhoz]"/>
    </designation>
    <designation>
      <language value="is"/>
      <value
             value="6.5 Gerð íláts og innihald[, sérstakur búnaður til notkunar lyfsins, lyfjagjafar eða ísetningar þess]"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value
             value="6.5 An cineál coimeádáin agus a bhfuil ann [agus trealamh speisialta lena úsáid, lena thabhairt nó lena ionphlandú]"/>
    </designation>
    <designation>
      <language value="it"/>
      <value
             value="6.5 Natura e contenuto del contenitore [e strumentazione particolare per l’uso, la somministrazione o l’impianto]"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value
             value="6.5. Iepakojuma veids un saturs [un īpašs aprīkojums lietošanai, ievadīšanai vai implantēšanai]"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value
             value="6.5 Talpyklės pobūdis ir jos turinys [bei speciali vartojimo ar implantavimo įranga]"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value
             value="6.5 In-natura tal-kontenitur u ta’ dak li hemm ġo fih [u apparat speċjali għall-użu, għall- amministrazzjoni jew għall-impjant]"/>
    </designation>
    <designation>
      <language value="no"/>
      <value
             value="6.5 Emballasje (type og innhold) [og spesielt utstyr for bruk, administrering eller implantasjon]"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value
             value="6.5 Rodzaj i zawartość opakowania [oraz specjalistyczny sprzęt, służący do używania, podawania lub implantacji]"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value
             value="6.5 Natureza e conteúdo do recipiente [e equipamento especial para utilização, administração ou implantação]"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value
             value="6.5 Natura și conținutul ambalajului [și echipamente speciale pentru utilizare, administrare sau implantare]"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value
             value="6.5 Druh obalu a obsah balenia [a špeciálne zariadenie na použitie, podanie alebo implantáciu]"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value
             value="6.5 Vrsta ovojnine in vsebina [ter posebna oprema za uporabo, dajanje ali implantacijo]"/>
    </designation>
    <designation>
      <language value="es"/>
      <value
             value="6.5 Naturaleza y contenido del envase [y de los equipos especiales para su utilización, administración o implantación]"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value
             value="6.5 Förpackningstyp och innehåll [och utrustning för användning, administrering eller implantation]"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029842"/>
    <display
             value="6.6 Special precautions for disposal [and other handling]"/>
    <designation>
      <language value="en"/>
      <value
             value="6.6 Special precautions for disposal [and other handling]"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="6.6 Специални предпазни мерки при изхвърляне [и работа]"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value
             value="6.6 Posebne mjere za zbrinjavanje [i druga rukovanja lijekom]"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value
             value="6.6 Zvláštní opatření pro likvidaci přípravku [a pro zacházení s ním]"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="6.6 Regler for bortskaffelse [og anden håndtering]"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value
             value="6.6 Speciale voorzorgsmaatregelen voor het verwijderen [en andere instructies]"/>
    </designation>
    <designation>
      <language value="et"/>
      <value
             value="6.6 Erihoiatused ravimpreparaadi hävitamiseks [ja käsitlemiseks]"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value
             value="6.6 Erityiset varotoimet hävittämiselle [ja muut käsittelyohjeet]"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value
             value="6.6 Précautions particulières d’élimination [et manipulation]"/>
    </designation>
    <designation>
      <language value="de"/>
      <value
             value="6.6 Besondere Vorsichtsmaßnahmen für die Beseitigung [und sonstige Hinweise zur Handhabung]"/>
    </designation>
    <designation>
      <language value="el"/>
      <value
             value="6.6 Ιδιαίτερες προφυλάξεις απόρριψης [και άλλος χειρισμός]"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value
             value="6.6 A megsemmisítésre vonatkozó különleges óvintézkedések [és egyéb, a készítmény kezelésével kapcsolatos információk]"/>
    </designation>
    <designation>
      <language value="is"/>
      <value
             value="6.6 Sérstakar varúðarráðstafanir við förgun [og önnur meðhöndlun]"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value
             value="6.6 Réamhchúraimí ar leith maidir le diúscairt [agus láimhsiú eile]"/>
    </designation>
    <designation>
      <language value="it"/>
      <value
             value="6.6 Precauzioni particolari per lo smaltimento [e la manipolazione]"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value
             value="6.6. Īpaši norādījumi atkritumu likvidēšanai [un citi norādījumi par rīkošanos]"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value
             value="6.6 Specialūs reikalavimai atliekoms tvarkyti [ir vaistiniam preparatui ruošti]"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value
             value="6.6 Prekawzjonijiet speċjali għar-rimi u għal immaniġġar ieħor"/>
    </designation>
    <designation>
      <language value="no"/>
      <value
             value="6.6 Spesielle forholdsregler for destruksjon [og annen håndtering]"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value
             value="6.6 Specjalne środki ostrożności dotyczące usuwania [i przygotowania produktu leczniczego do stosowania]"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="6.6 Precauções especiais de eliminação [e manuseamento]"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value
             value="6.6 Precauții speciale pentru eliminarea reziduurilor [și alte instrucțiuni de manipulare]"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value
             value="6.6 Špeciálne opatrenia na likvidáciu [a iné zaobchádzanie s liekom]"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value
             value="6.6 Posebni varnostni ukrepi za odstranjevanje [in rokovanje z zdravilom]"/>
    </designation>
    <designation>
      <language value="es"/>
      <value
             value="6.6 Precauciones especiales de eliminación [y otras manipulaciones]"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value
             value="6.6 Särskilda anvisningar för destruktion [och övrig hantering]"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029843"/>
    <display value="Use in the paediatric population"/>
    <designation>
      <language value="en"/>
      <value value="Use in the paediatric population"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Употреба при педиатричната популация"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Primjena u pedijatrijskoj populaciji"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Použití u pediatrické populace"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Brug i den pædiatriske population"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Gebruik bij pediatrische patiënten"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Kasutamine lastel"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Käyttö pediatrisille potilaille"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Utilisation dans la population pédiatrique"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Anwendung bei Kindern und Jugendlichen"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Χρήση στον παιδιατρικό πληθυσμό."/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Alkalmazása gyermekek és serdülők esetén"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Ef lyfið er notað handa börnum"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Úsáid sa daonra péidiatrach"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Uso nella popolazione pediatrica"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Lietošana pediatriskā populācijā"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Vartojimas vaikų populiacijai"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Użu fil-popolazzjoni pedjatrika"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Bruk i den pediatriske populasjonen"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Stosowanie u dzieci i młodzieży"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Utilização na população pediátrica"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Utilizare la copii și adolescenți"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Použitie v pediatrickej populácii"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Uporaba pri pediatrični populaciji"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Uso en la población pediátrica"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Användning i den pediatriska populationen"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029844"/>
    <display value="7. MARKETING AUTHORISATION HOLDER"/>
    <designation>
      <language value="en"/>
      <value value="7. MARKETING AUTHORISATION HOLDER"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="7. ПРИТЕЖАТЕЛ НА РАЗРЕШЕНИЕТО ЗА УПОТРЕБА"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="7. NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="7. DRŽITEL ROZHODNUTÍ O REGISTRACI"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="7. INDEHAVER AF MARKEDSFØRINGSTILLADELSEN"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value
             value="7. HOUDER VAN DE VERGUNNING VOOR HET IN DE HANDEL BRENGEN"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="7. MÜÜGILOA HOIDJA"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="7. MYYNTILUVAN HALTIJA"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="7. TITULAIRE DE L’AUTORISATION DE MISE SUR LE MARCHÉ"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="7. INHABER DER ZULASSUNG"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="7. ΚΑΤΟΧΟΣ ΤΗΣ ΑΔΕΙΑΣ ΚΥΚΛΟΦΟΡΙΑΣ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="7. A FORGALOMBA HOZATALI ENGEDÉLY JOGOSULTJA"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="7. MARKAÐSLEYFISHAFI"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="7. SEALBHÓIR AN ÚDARAITHE MARGAÍOCHTA"/>
    </designation>
    <designation>
      <language value="it"/>
      <value
             value="7. TITOLARE DELL’AUTORIZZAZIONE ALL’IMMISSIONE IN COMMERCIO"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="7. REĢISTRĀCIJAS APLIECĪBAS ĪPAŠNIEKS"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="7. REGISTRUOTOJAS"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="7. DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="7. INNEHAVER AV MARKEDSFØRINGSTILLATELSEN"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value
             value="7. PODMIOT ODPOWIEDZIALNY POSIADAJĄCY POZWOLENIE NA DOPUSZCZENIE DO OBROTU"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="7. TITULAR DA AUTORIZAÇÃO DE INTRODUÇÃO NO MERCADO"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="7. DEȚINĂTORUL AUTORIZAȚIEI DE PUNERE PE PIAȚĂ"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="7. DRŽITEĽ ROZHODNUTIA O REGISTRÁCII"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="7. IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="7. TITULAR DE LA AUTORIZACIÓN DE COMERCIALIZACIÓN"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="7. INNEHAVARE AV GODKÄNNANDE FÖR FÖRSÄLJNING"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029845"/>
    <display value="8. MARKETING AUTHORISATION NUMBER(S)"/>
    <designation>
      <language value="en"/>
      <value value="8. MARKETING AUTHORISATION NUMBER(S)"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="8. НОМЕР(А) НА РАЗРЕШЕНИЕТО ЗА УПОТРЕБА"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="8. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="8. REGISTRAČNÍ ČÍSLO/REGISTRAČNÍ ČÍSLA"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="8. MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE)"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value
             value="8. NUMMER(S) VAN DE VERGUNNING VOOR HET IN DE HANDEL BRENGEN"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="8. MÜÜGILOA NUMBER (NUMBRID)"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="8. MYYNTILUVAN NUMERO(T)"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="8. NUMÉRO(S) D’AUTORISATION DE MISE SUR LE MARCHÉ"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="8. ZULASSUNGSNUMMER(N)"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="8. ΑΡΙΘΜΟΣ(ΟΙ) ΑΔΕΙΑΣ ΚΥΚΛΟΦΟΡΙΑΣ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="8. A FORGALOMBA HOZATALI ENGEDÉLY SZÁMA(I)"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="8. MARKAÐSLEYFISNÚMER"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="8. UIMHIR/UIMHREACHA AN ÚDARAITHE MARGAÍOCHTA"/>
    </designation>
    <designation>
      <language value="it"/>
      <value
             value="8. NUMERO(I) DELL’AUTORIZZAZIONE ALL’IMMISSIONE IN COMMERCIO"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="8. REĢISTRĀCIJAS APLIECĪBAS NUMURS(-I)"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="8. REGISTRACIJOS PAŽYMĖJIMO NUMERIS (-IAI)"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="8. NUMRU(I) TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="8. MARKEDSFØRINGSTILLATELSESNUMMER (NUMRE)"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value
             value="8. [NUMER POZWOLENIA] [NUMERY POZWOLEŃ] NA DOPUSZCZENIE DO OBROTU"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="8. NÚMERO(S) DA AUTORIZAÇÃO DE INTRODUÇÃO NO MERCADO"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="8. NUMĂRUL(ELE) AUTORIZAȚIEI DE PUNERE PE PIAȚĂ"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="8. REGISTRAČNÉ [ČÍSLO] [ČÍSLA]"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value
             value="8. ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="8. NÚMERO(S) DE AUTORIZACIÓN DE COMERCIALIZACIÓN"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="8. NUMMER PÅ GODKÄNNANDE FÖR FÖRSÄLJNING"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029846"/>
    <display
             value="9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION"/>
    <designation>
      <language value="en"/>
      <value
             value="9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value
             value="9. ДАТА НА ПЪРВО РАЗРЕШАВАНЕ/ПОДНОВЯВАНЕ НА РАЗРЕШЕНИЕТО ЗА УПОТРЕБА"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="9. DATUM PRVOG ODOBRENJA / DATUM OBNOVE ODOBRENJA"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="9. DATUM PRVNÍ REGISTRACE/PRODLOUŽENÍ REGISTRACE"/>
    </designation>
    <designation>
      <language value="da"/>
      <value
             value="9. DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value
             value="9. DATUM VAN EERSTE VERLENING VAN DE VERGUNNING/VERLENGING VAN DE VERGUNNING"/>
    </designation>
    <designation>
      <language value="et"/>
      <value
             value="9. ESMASE MÜÜGILOA VÄLJASTAMISE/MÜÜGILOA UUENDAMISE KUUPÄEV"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="9. MYYNTILUVAN MYÖNTÄMISPÄIVÄMÄÄRÄ/UUDISTAMISPÄIVÄMÄÄRÄ"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value
             value="9. DATE DE PREMIÈRE AUTORISATION/DE RENOUVELLEMENT DE L’AUTORISATION"/>
    </designation>
    <designation>
      <language value="de"/>
      <value
             value="9. DATUM DER ERTEILUNG DER ZULASSUNG/VERLÄNGERUNG DER ZULASSUNG"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="9. ΗΜΕΡΟΜΗΝΙΑ ΠΡΩΤΗΣ ΕΓΚΡΙΣΗΣ/ΑΝΑΝΕΩΣΗΣ ΤΗΣ ΑΔΕΙΑΣ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value
             value="9. A FORGALOMBA HOZATALI ENGEDÉLY ELSŐ KIADÁSÁNAK/ MEGÚJÍTÁSÁNAK DÁTUMA"/>
    </designation>
    <designation>
      <language value="is"/>
      <value
             value="9. DAGSETNING FYRSTU ÚTGÁFU MARKAÐSLEYFIS / ENDURNÝJUNAR MARKAÐSLEYFIS"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="9. DÁTA AN CHÉAD ÚDARAITHE/ATHNUACHAN AN ÚDARAITHE"/>
    </designation>
    <designation>
      <language value="it"/>
      <value
             value="9. DATA DELLA PRIMA AUTORIZZAZIONE/RINNOVO DELL’AUTORIZZAZIONE"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="9. PIRMĀS REĢISTRĀCIJAS/PĀRREĢISTRĀCIJAS DATUMS"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="9. REGISTRAVIMO / PERREGISTRAVIMO DATA"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value
             value="9. DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI"/>
    </designation>
    <designation>
      <language value="no"/>
      <value
             value="9. DATO FOR FØRSTE MARKEDSFØRINGSTILLATELSE / SISTE FORNYELSE"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value
             value="9. DATA WYDANIA PIERWSZEGO POZWOLENIA NA DOPUSZCZENIE DO OBROTU I DATA PRZEDŁUŻENIA POZWOLENIA"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value
             value="9. DATA DA PRIMEIRA AUTORIZAÇÃO/RENOVAÇÃO DA AUTORIZAÇÃO DE INTRODUÇÃO NO MERCADO"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="9. DATA PRIMEI AUTORIZĂRI SAU A REÎNNOIRII AUTORIZAȚIEI"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="9. DÁTUM PRVEJ REGISTRÁCIE/PREDĹŽENIA REGISTRÁCIE"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value
             value="9. DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM"/>
    </designation>
    <designation>
      <language value="es"/>
      <value
             value="9. FECHA DE LA PRIMERA AUTORIZACIÓN/RENOVACIÓN DE LA AUTORIZACIÓN"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="9. DATUM FÖR FÖRSTA GODKÄNNANDE/FÖRNYAT GODKÄNNANDE"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029847"/>
    <display value="10. DATE OF REVISION OF THE TEXT"/>
    <designation>
      <language value="en"/>
      <value value="10. DATE OF REVISION OF THE TEXT"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="10. ДАТА НА АКТУАЛИЗИРАНЕ НА ТЕКСТА"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="10. DATUM REVIZIJE TEKSTA"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="10. DATUM REVIZE TEXTU"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="10. DATO FOR ÆNDRING AF TEKSTEN"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="10. DATUM VAN HERZIENING VAN DE TEKST"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="10. TEKSTI LÄBIVAATAMISE KUUPÄEV"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="10. TEKSTIN MUUTTAMISPÄIVÄMÄÄRÄ"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="10. DATE DE MISE À JOUR DU TEXTE"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="10. STAND DER INFORMATION"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="10. ΗΜΕΡΟΜΗΝΙΑ ΑΝΑΘΕΩΡΗΣΗΣ ΤΟΥ ΚΕΙΜΕΝΟΥ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="10. A SZÖVEG ELLENŐRZÉSÉNEK DÁTUMA"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="10. DAGSETNING ENDURSKOÐUNAR TEXTANS"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="10. DÁTA ATHBHREITHNITHE AN TÉACS"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="10. DATA DI REVISIONE DEL TESTO"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="10. TEKSTA PĀRSKATĪŠANAS DATUMS"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="10. TEKSTO PERŽIŪROS DATA"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="10. DATA TA’ REVIŻJONI TAT-TEST"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="10. OPPDATERINGSDATO"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value
             value="10. DATA ZATWIERDZENIA LUB CZĘŚCIOWEJ ZMIANY TEKSTU CHARAKTERYSTYKI PRODUKTU LECZNICZEGO"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="10. DATA DA REVISÃO DO TEXTO"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="10. DATA REVIZUIRII TEXTULUI"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="10. DÁTUM REVÍZIE TEXTU"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="10. DATUM ZADNJE REVIZIJE BESEDILA"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="10. FECHA DE LA REVISIÓN DEL TEXTO"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="10. DATUM FÖR ÖVERSYN AV PRODUKTRESUMÉN"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029848"/>
    <display value="11. DOSIMETRY"/>
    <designation>
      <language value="en"/>
      <value value="11. DOSIMETRY"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="11. ДОЗИМЕТРИЯ"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="11. DOZIMETRIJA"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="11. DOZIMETRIE"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="11. DOSIMETRI"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="11. DOSIMETRIE"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="11. DOSIMEETRIA"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="11. DOSIMETRIA"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="11. DOSIMÉTRIE"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="11. DOSIMETRIE"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="11. ΔΟΣΙΜΕΤΡΙΑ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="11. VÁRHATÓ SUGÁRTERHELÉS"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="11. GEISLUNARMÆLINGAR"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="11. DÁILEOGMHÉADRACHT"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="11. DOSIMETRIA"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="11. DOZIMETRIJA"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="11. DOZIMETRIJA"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="11. DOŻIMETRIJA"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="11. DOSIMETRI"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="11. DOZYMETRIA"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="11. DOSIMETRIA"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="11. DOZIMETRIE"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="11. DOZIMETRIA"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="11. DOZIMETRIJA"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="11. DOSIMETRÍA"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="11. ABSORBERAD DOS OCH EFFEKTIV DOS"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029849"/>
    <display
             value="12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS"/>
    <designation>
      <language value="en"/>
      <value
             value="12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="12. ИНСТРУКЦИИ ЗА ПРИГОТВЯНЕ НА РАДИОФАРМАЦЕВТИЦИ"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="12. UPUTE ZA PRIPREMU RADIOFARMACEUTIKA"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="12. NÁVOD PRO PŘÍPRAVU RADIOFARMAK"/>
    </designation>
    <designation>
      <language value="da"/>
      <value
             value="12. INSTRUKTIONER FOR FREMSTILLING AF RADIOAKTIVE LÆGEMIDLER"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value
             value="12. INSTRUCTIES VOOR DE BEREIDING VAN RADIOACTIEVE GENEESMIDDELEN"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="12. RADIOFARMATSEUTILISE PREPARAADI VALMISTAMISE JUHEND"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="12. RADIOFARMASEUTTISTEN VALMISTEIDEN VALMISTUSOHJEET"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value
             value="12. INSTRUCTIONS POUR LA PRÉPARATION DES RADIOPHARMACEUTIQUES"/>
    </designation>
    <designation>
      <language value="de"/>
      <value
             value="12. ANWEISUNGEN ZUR ZUBEREITUNG VON RADIOAKTIVEN ARZNEIMITTELN"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="12. ΟΔΗΓΙΕΣ ΠΑΡΑΣΚΕΥΗΣ ΡΑΔΙΟΦΑΡΜΑΚΩΝ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value
             value="12. RADIOAKTÍV GYÓGYSZEREK ELKÉSZÍTÉSÉRE VONATKOZÓ ÚTMUTATÁSOK"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="12. LEIÐBEININGAR UM BLÖNDUN GEISLAVIRKRA LYFJA"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="12. TREORACHA CHUN RADACHÓGAIS A ULLMHÚ"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="12. ISTRUZIONI PER LA PREPARAZIONE DI RADIOFARMACI"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="12. NORĀDĪJUMI PAR RADIOFARMACEITISKO ZĀĻU SAGATAVOŠANU"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="12. RADIOFARMACINIŲ PREPARATŲ RUOŠIMO INSTRUKCIJA"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value
             value="12. ISTRUZZJONIJIET GĦALL-PREPARAZZJONI TA’ PRODOTTI RADJUFARMAĊEWTIĊI"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="12. INSTRUKSJONER FOR TILBEREDELSE AV RADIOFARMAKA"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value
             value="12. INSTRUKCJA PRZYGOTOWANIA PRODUKTÓW RADIOFARMACEUTYCZNYCH"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="12. INSTRUÇÕES PARA A PREPARAÇÃO DE RADIOFÁRMACOS"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value
             value="12. INSTRUCȚIUNI PRIVIND PREPARAREA MEDICAMENTELOR RADIOFARMACEUTICE"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="12. POKYNY NA PRÍPRAVU RÁDIOFARMÁK"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="12. NAVODILA ZA PRIPRAVO RADIOFARMAKOV"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="12. INSTRUCCIONES PARA LA PREPARACIÓN DE RADIOFÁRMACOS"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="12. INSTRUKTION FÖR BEREDNING AV RADIOFARMAKA"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029850"/>
    <display value="ANNEX II"/>
    <designation>
      <language value="en"/>
      <value value="ANNEX II"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="ПРИЛОЖЕНИЕ II"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="PRILOG II."/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="PŘÍLOHA II"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="BILAG II"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="BIJLAGE II"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="II LISA"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="LIITE II"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="ANNEXE II"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="ANHANG II"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="ΠΑΡΑΡΤΗΜΑ ΙΙ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="II. MELLÉKLET"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="VIÐAUKI II"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="IARSCRÍBHINN II"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="ALLEGATO II"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="II PIELIKUMS"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="II PRIEDAS"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="ANNESS II"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="VEDLEGG II"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="ANEKS II"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="ANEXO II"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="ANEXA II"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="PRÍLOHA II"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="PRILOGA II"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="ANEXO II"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="BILAGA II"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029851"/>
    <display
             value="A. [MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND] MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE"/>
    <designation>
      <language value="en"/>
      <value
             value="A. [MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND] MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value
             value="A. [ПРОИЗВОДИТЕЛ(И) НА БИОЛОГИЧНО АКТИВНОТО(ИТЕ) ВЕЩЕСТВО(А) И]ПРОИЗВОДИТЕЛ(И), ОТГОВОРЕН(НИ) ЗА ОСВОБОЖДАВАНЕ НА ПАРТИДИ"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value
             value="A. [PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I] PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value
             value="A. [VÝROBCE/VÝROBCI BIOLOGICKÉ LÉČIVÉ LÁTKY/BIOLOGICKÝCH LÉČIVÝCH LÁTEK A] VÝROBCE ODPOVĚDNÝ/VÝROBCI ODPOVĚDNÍ ZA PROPOUŠTĚNÍ ŠARŽÍ"/>
    </designation>
    <designation>
      <language value="da"/>
      <value
             value="A. [FREMSTILLER(E) AF DET (DE) BIOLOGISK AKTIVE STOF(FER) OG] FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value
             value="A. [FABRIKANT(EN) VAN DE BIOLOGISCH WERKZAME STOF(FEN) EN ]FABRIKANT(EN) VERANTWOORDELIJK VOOR VRIJGIFTE"/>
    </designation>
    <designation>
      <language value="et"/>
      <value
             value="A. [BIOLOOGILIS(T)E TOIMEAINE(TE) TOOTJA(D) JA] RAVIMIPARTII KASUTAMISEKS VABASTAMISE EEST VASTUTAV(AD) TOOTJA(D)"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value
             value="A. [BIOLOGISEN (BIOLOGISTEN) VAIKUTTAVAN (VAIKUTTAVIEN) AINEEN (AINEIDEN) VALMISTAJA (VALMISTAJAT) JA] ERÄN VAPAUTTAMISESTA VASTAAVA(T) VALMISTAJA(T)"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value
             value="A. [FABRICANT(S) DE LA/DES SUBSTANCE(S) ACTIVE(S) D’ORIGINE BIOLOGIQUE ET ] FABRICANT(S) RESPONSABLE(S) DE LA LIBÉRATION DES LOTS"/>
    </designation>
    <designation>
      <language value="de"/>
      <value
             value="A. [HERSTELLER DES WIRKSTOFFS/DER WIRKSTOFFE BIOLOGISCHEN URSPRUNGS UND] HERSTELLER, DER (DIE) FÜR DIE CHARGENFREIGABE VERANTWORTLICH IST (SIND)"/>
    </designation>
    <designation>
      <language value="el"/>
      <value
             value="Α. [ ΠΑΡΑΣΚΕΥΑΣΤΗΣ(ΕΣ) ΤΗΣ(ΤΩΝ) ΒΙΟΛΟΓΙΚΩΣ ΔΡΑΣΤΙΚΗΣ(ΩΝ) ΟΥΣΙΑΣ(ΩΝ) ΚΑΙ] ΠΑΡΑΣΚΕΥΑΣΤΗΣ(ΕΣ) ΥΠΕΥΘΥΝΟΣ(ΟΙ) ΓΙΑ ΤΗΝ ΑΠΟΔΕΣΜΕΥΣΗ ΤΩΝ ΠΑΡΤΙΔΩΝ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value
             value="A. [A BIOLÓGIAI EREDETŰ HATÓANYAG(OK) GYÁRTÓJA/GYÁRTÓI ÉS]A GYÁRTÁSI TÉTELEK VÉGFELSZABADÍTÁSÁÉRT FELELŐS GYÁRTÓ(K)"/>
    </designation>
    <designation>
      <language value="is"/>
      <value
             value="A. [FRAMLEIÐENDUR LÍFFRÆÐILEGRA VIRKRA EFNA OG ]FRAMLEIÐENDUR SEM ERU ÁBYRGIR FYRIR LOKASAMÞYKKT"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value
             value="A. [MONARÓIR(Í) NA SUBSTAINTE GNÍOMHAÍ BITHEOLAÍCHE/NA SUBSTAINTÍ GNÍOMHACHA BITHEOLAÍOCHA AGUS] MONARÓIR(Í) ATÁ FREAGRACH AS BAISCEANNA A SCAOILEADH"/>
    </designation>
    <designation>
      <language value="it"/>
      <value
             value="A. [PRODUTTORE(I) DEL(DEI) PRINCIPIO(I) ATTIVO(I) BIOLOGICO(I) E] PRODUTTORE(I) RESPONSABILE(I) DEL RILASCIO DEI LOTTI"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value
             value="A. [BIOLOĢISKI AKTĪVĀS(-O) VIELAS (-U) RAŽOTĀJS(-I) UN] RAŽOTĀJS(-I), KAS ATBILD PAR SĒRIJAS IZLAIDI"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value
             value="A. [BIOLOGINĖS (-IŲ) VEIKLIOSIOS (-IŲJŲ) MEDŽIAGOS (-Ų) GAMINTOJAS (-AI) IR] GAMINTOJAS (-AI), ATSAKINGAS (-I) UŽ SERIJŲ IŠLEIDIMĄ"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value
             value="A. [MANIFATTUR(I) TAS-SUSTANZA/I) BIJOLOĠIKA(ĊI ATTIVA/I U] MANIFATTUR(I) RESPONSABBLI GĦALL-ĦRUĠ TAL-LOTT"/>
    </designation>
    <designation>
      <language value="no"/>
      <value
             value="A. [TILVIRKER(E) AV BIOLOGISK (E) VIRKESTOFF(ER) OG] TILVIRKER(E) ANSVARLIG FOR BATCH RELEASE"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value
             value="A. [WYTWÓRCA] [WYTWÓRCY] [BIOLOGICZNEJ SUBSTANCJI CZYNNEJ] [BIOLOGICZNYCH SUBSTANCJI CZYNNYCH] ORAZ] [WYTWÓRCA ODPOWIEDZIALNY] [WYTWÓRCY ODPOWIEDZIALNI] ZA ZWOLNIENIE SERII"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value
             value="A. [FABRICANTE(S) DA(S) SUBSTÂNCIA(S) ATIVA(S) DE ORIGEM BIOLÓGICA E]FABRICANTE(S) RESPONSÁVEL(VEIS) PELA LIBERTAÇÃO DO LOTE"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value
             value="A. [FABRICANTUL(FABRICANȚII) SUBSTANȚEI(LOR) BIOLOGIC ACTIVE ȘI] FABRICANTUL (FABRICANȚII) RESPONSABIL(I) PENTRU ELIBERAREA SERIEI"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value
             value="A. [VÝROBCA (VÝROBCOVIA) BIOLOGICKÉHO LIEČIVA (BIOLOGICKÝCH LIEČIV) A]VÝROBCA (VÝROBCOVIA) ZODPOVEDNÝ (ZODPOVEDNÍ) ZA UVOĽNENIE ŠARŽE"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value
             value="A. [PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN] PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ"/>
    </designation>
    <designation>
      <language value="es"/>
      <value
             value="A. [FABRICANTE(S) DEL (DE LOS) PRINCIPIO(S) ACTIVO(S) BIOLÓGICO(S) Y] FABRICANTE(S) RESPONSABLE(S) DE LA LIBERACIÓN DE LOS LOTES"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value
             value="A. [ TILLVERKARE AV DEN (DE) AKTIVA SUBSTANSEN (SUBSTANSERNA) AV BIOLOGISKT URSPRUNG OCH ] TILLVERKARE SOM ANSVARAR FÖR FRISLÄPPANDE AV TILLVERKNINGSSATS"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029852"/>
    <display value="B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE"/>
    <designation>
      <language value="en"/>
      <value value="B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Б. УСЛОВИЯ ИЛИ ОГРАНИЧЕНИЯ ЗА ДОСТАВКА И УПОТРЕБА"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="B. PODMÍNKY NEBO OMEZENÍ VÝDEJE A POUŽITÍ"/>
    </designation>
    <designation>
      <language value="da"/>
      <value
             value="B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value
             value="B. VOORWAARDEN OF BEPERKINGEN TEN AANZIEN VAN LEVERING EN GEBRUIK"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="B. HANKE- JA KASUTUSTINGIMUSED VÕI PIIRANGUD"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value
             value="B. TOIMITTAMISEEN JA KÄYTTÖÖN LIITTYVÄT EHDOT TAI RAJOITUKSET"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value
             value="B. CONDITIONS OU RESTRICTIONS DE DÉLIVRANCE ET D’UTILISATION"/>
    </designation>
    <designation>
      <language value="de"/>
      <value
             value="B. BEDINGUNGEN ODER EINSCHRÄNKUNGEN FÜR DIE ABGABE UND DEN GEBRAUCH"/>
    </designation>
    <designation>
      <language value="el"/>
      <value
             value="Β. ΟΡΟΙ Ή ΠΕΡΙΟΡΙΣΜΟΙ ΣΧΕΤΙΚΑ ΜΕ ΤΗ ΔΙΑΘΕΣΗ ΚΑΙ ΤΗ ΧΡΗΣΗ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value
             value="B. A KIADÁSRA ÉS A FELHASZNÁLÁSRA VONATKOZÓ FELTÉTELEK VAGY KORLÁTOZÁSOK"/>
    </designation>
    <designation>
      <language value="is"/>
      <value
             value="B. FORSENDUR FYRIR, EÐA TAKMARKANIR Á, AFGREIÐSLU OG NOTKUN"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value
             value="B. COINNÍOLLACHA NÓ SRIANTA MAIDIR LE SOLÁTHAR AGUS ÚSÁID"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="B. CONDIZIONI O LIMITAZIONI DI FORNITURA E UTILIZZO"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value
             value="B. IZSNIEGŠANAS KĀRTĪBAS UN LIETOŠANAS NOSACĪJUMI VAI IEROBEŽOJUMI"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="B. TIEKIMO IR VARTOJIMO SĄLYGOS AR APRIBOJIMAI"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value
             value="B. KONDIZZJONIJIET JEW RESTRIZZJONIJIET RIGWARD IL-PROVVISTA U L-UŻU"/>
    </designation>
    <designation>
      <language value="no"/>
      <value
             value="B. VILKÅR ELLER RESTRIKSJONER VEDRØRENDE LEVERANSE OG BRUK"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value
             value="B. WARUNKI LUB OGRANICZENIA DOTYCZĄCE ZAOPATRZENIA I STOSOWANIA"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value
             value="B. CONDIÇÕES OU RESTRIÇÕES RELATIVAS AO FORNECIMENTO E UTILIZAÇÃO"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value
             value="B. CONDIȚII SAU RESTRICȚII PRIVIND FURNIZAREA ȘI UTILIZAREA"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value
             value="B. PODMIENKY ALEBO OBMEDZENIA TÝKAJÚCE SA VÝDAJA A POUŽITIA"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="B. CONDICIONES O RESTRICCIONES DE SUMINISTRO Y USO"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value
             value="B. VILLKOR ELLER BEGRÄNSNINGAR FÖR TILLHANDAHÅLLANDE OCH ANVÄNDNING"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029853"/>
    <display value="Official batch release"/>
    <designation>
      <language value="en"/>
      <value value="Official batch release"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Официално освобождаване на партиди"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Službeno puštanje serije lijeka u promet"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Úřední propouštění šarží"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Officiel batchfrigivelse"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Officiële vrijgifte van de batch"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Ravimipartii ametlik kasutamiseks vabastamine"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Erän virallinen vapauttaminen"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Libération officielle des lots"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Amtliche Chargenfreigabe"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Επίσημη αποδέσμευση παρτίδων"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Gyártási tételek hivatalos végfelszabadítása"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Opinber lokasamþykkt"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Scaoileadh baisce oifigiúil"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Rilascio ufficiale dei lotti"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Oficiāla sērijas izlaide"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Oficialus serijų išleidimas"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Ħruġ tal-lott uffiċjali"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Offisiell batch release"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Oficjalne zwalnianie serii"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Libertação oficial do lote"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Eliberarea oficială a seriei"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Oficiálne uvoľnenie šarže"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Uradna sprostitev serije:"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Liberación oficial de los lotes"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Officiellt frisläppande av tillverkningssats"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029854"/>
    <display
             value="C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION"/>
    <designation>
      <language value="en"/>
      <value
             value="C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value
             value="В. ДРУГИ УСЛОВИЯ И ИЗИСКВАНИЯ НА РАЗРЕШЕНИЕТО ЗА УПОТРЕБА"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value
             value="C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="C. DALŠÍ PODMÍNKY A POŽADAVKY REGISTRACE"/>
    </designation>
    <designation>
      <language value="da"/>
      <value
             value="C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value
             value="C. ANDERE VOORWAARDEN EN EISEN DIE DOOR DE HOUDER VAN DE HANDELSVERGUNNING MOETEN WORDEN NAGEKOMEN"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="C. MÜÜGILOA MUUD TINGIMUSED JA NÕUDED"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="C. MYYNTILUVAN MUUT EHDOT JA EDELLYTYKSET"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value
             value="C. AUTRES CONDITIONS ET OBLIGATIONS DE L’AUTORISATION DE MISE SUR LE MARCHÉ"/>
    </designation>
    <designation>
      <language value="de"/>
      <value
             value="C. SONSTIGE BEDINGUNGEN UND AUFLAGEN DER GENEHMIGUNG FÜR DAS INVERKEHRBRINGEN]"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Γ. ΑΛΛΟΙ ΟΡΟΙ ΚΑΙ ΑΠΑΙΤΗΣΕΙΣ ΤΗΣ ΑΔΕΙΑΣ ΚΥΚΛΟΦΟΡΙΑΣ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value
             value="C. A FORGALOMBA HOZATALI ENGEDÉLYBEN FOGLALT EGYÉB FELTÉTELEK ÉS KÖVETELMÉNYEK"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="C. AÐRAR FORSENDUR OG SKILYRÐI MARKAÐSLEYFIS"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value
             value="C. COINNÍOLLACHA AGUS CEANGLAIS EILE DE CHUID AN ÚDARAITHE MARGAÍOCHTA"/>
    </designation>
    <designation>
      <language value="it"/>
      <value
             value="C. ALTRE CONDIZIONI E REQUISITI DELL’AUTORIZZAZIONE ALL’IMMISSIONE IN COMMERCIO"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="C. CITI REĢISTRĀCIJAS NOSACĪJUMI UN PRASĪBAS"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="C. KITOS SĄLYGOS IR REIKALAVIMAI REGISTRUOTOJUI"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value
             value="C. KONDIZZJONIJIET U REKWIŻITI OĦRA TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="C. ANDRE VILKÅR OG KRAV TIL MARKEDSFØRINGSTILLATELSEN"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value
             value="C. INNE WARUNKI I WYMAGANIA DOTYCZĄCE DOPUSZCZENIA DO OBROTU"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value
             value="C. OUTRAS CONDIÇÕES E REQUISITOS DA AUTORIZAÇÃO DE INTRODUÇÃO NO MERCADO"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value
             value="C. ALTE CONDIȚII ȘI CERINȚE ALE AUTORIZAȚIEI DE PUNERE PE PIAȚĂ"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="C. ĎALŠIE PODMIENKY A POŽIADAVKY REGISTRÁCIE"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value
             value="C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM"/>
    </designation>
    <designation>
      <language value="es"/>
      <value
             value="C. OTRAS CONDICIONES Y REQUISITOS DE LA AUTORIZACIÓN DE COMERCIALIZACIÓN"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value
             value="C. ÖVRIGA VILLKOR OCH KRAV FÖR GODKÄNNANDET FÖR FÖRSÄLJNING"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029855"/>
    <display value="Periodic safety update reports (PSURs)"/>
    <designation>
      <language value="en"/>
      <value value="Periodic safety update reports (PSURs)"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Периодични актуализирани доклади за безопасност (ПАДБ)"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Periodička izvješća o neškodljivosti lijeka (PSUR-evi)"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Pravidelně aktualizované zprávy o bezpečnosti (PSUR)"/>
    </designation>
    <designation>
      <language value="da"/>
      <value
             value="Periodiske, opdaterede sikkerhedsindberetninger (PSUR’er)"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Periodieke veiligheidsverslagen"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Perioodilised ohutusaruanded"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Määräaikaiset turvallisuuskatsaukset"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Rapports périodiques actualisés de sécurité (PSURs)"/>
    </designation>
    <designation>
      <language value="de"/>
      <value
             value="Regelmäßig aktualisierte Unbedenklichkeitsberichte [Periodic Safety Update Reports (PSURs)]"/>
    </designation>
    <designation>
      <language value="el"/>
      <value
             value="Εκθέσεις περιοδικής παρακολούθησης της ασφάλειας (PSURs)"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value
             value="Időszakos gyógyszerbiztonsági jelentések (Periodic safety update report, PSUR)"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Samantektir um öryggi lyfsins (PSUR)"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value
             value="Tuarascálacha tréimhsiúla chun dáta maidir le sábháilteacht (PSURanna)"/>
    </designation>
    <designation>
      <language value="it"/>
      <value
             value="Rapporti periodici di aggiornamento sulla sicurezza (PSUR)"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Periodiski atjaunojamais drošuma ziņojums (PSUR)"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Periodiškai atnaujinami saugumo protokolai (PASP)"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Rapporti perjodiċi aġġornati dwar is-sigurtà (PSURs)"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Periodiske sikkerhetsoppdateringsrapporter (PSUR-er)"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value
             value="Okresowe raporty o bezpieczeństwie stosowania (ang. Periodic safety update reports, PSURs)"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Relatórios periódicos de segurança (RPS)"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value
             value="Rapoartele periodice actualizate privind siguranța (RPAS)"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value
             value="Periodicky aktualizované správy o bezpečnosti (Periodic safety update reports, PSUR)"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Redno posodobljena poročila o varnosti zdravila (PSUR)"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Informes periódicos de seguridad (IPSs)"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Periodiska säkerhetsrapporter"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029856"/>
    <display
             value="D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT"/>
    <designation>
      <language value="en"/>
      <value
             value="D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value
             value="Г. УСЛОВИЯ ИЛИ ОГРАНИЧЕНИЯ ЗА БЕЗОПАСНА И ЕФЕКТИВНА УПОТРЕБА НА ЛЕКАРСТВЕНИЯ ПРОДУКТ"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value
             value="D. UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value
             value="D. PODMÍNKY NEBO OMEZENÍ S OHLEDEM NA BEZPEČNÉ A ÚČINNÉ POUŽÍVÁNÍ LÉČIVÉHO PŘÍPRAVKU"/>
    </designation>
    <designation>
      <language value="da"/>
      <value
             value="D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value
             value="D. VOORWAARDEN OF BEPERKINGEN MET BETREKKING TOT EEN VEILIG EN DOELTREFFEND GEBRUIK VAN HET GENEESMIDDEL"/>
    </designation>
    <designation>
      <language value="et"/>
      <value
             value="D. RAVIMPREPARAADI OHUTU JA EFEKTIIVSE KASUTAMISE TINGIMUSED JA PIIRANGUD"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value
             value="D. EHDOT TAI RAJOITUKSET, JOTKA KOSKEVAT LÄÄKEVALMISTEEN TURVALLISTA JA TEHOKASTA KÄYTTÖÄ"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value
             value="D. CONDITIONS OU RESTRICTIONS EN VUE D’UNE UTILISATION SÛRE ET EFFICACE DU MÉDICAMENT"/>
    </designation>
    <designation>
      <language value="de"/>
      <value
             value="D. BEDINGUNGEN ODER EINSCHRÄNKUNGEN FÜR DIE SICHERE UND WIRKSAME ANWENDUNG DES ARZNEIMITTELS"/>
    </designation>
    <designation>
      <language value="el"/>
      <value
             value="Δ. ΟΡΟΙ Ή ΠΕΡΙΟΡΙΣΜΟΙ ΣΧΕΤΙΚΑ ΜΕ ΤΗΝ ΑΣΦΑΛΗ ΚΑΙ ΑΠΟΤΕΛΕΣΜΑΤΙΚΗ ΧΡΗΣΗ ΤΟΥ ΦΑΡΜΑΚΕΥΤΙΚΟΥ ΠΡΟΪΟΝΤΟΣ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value
             value="D. A GYÓGYSZER BIZTONSÁGOS ÉS HATÉKONY ALKALMAZÁSÁRA VONATKOZÓ FELTÉTELEK VAGY KORLÁTOZÁSOK"/>
    </designation>
    <designation>
      <language value="is"/>
      <value
             value="D. FORSENDUR EÐA TAKMARKANIR ER VARÐA ÖRYGGI OG VERKUN VIÐ NOTKUN LYFSINS"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value
             value="D. COINNÍOLLACHA NÓ SRIANTA MAIDIR LE hÚSÁID SHÁBHÁILTE ÉIFEACHTACH AN TÁIRGE ÍOCSHLÁINTE"/>
    </designation>
    <designation>
      <language value="it"/>
      <value
             value="D. CONDIZIONI O LIMITAZIONI PER QUANTO RIGUARDA L’USO SICURO ED EFFICACE DEL MEDICINALE"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value
             value="D. NOSACĪJUMI VAI IEROBEŽOJUMI ATTIECĪBĀ UZ DROŠU UN EFEKTĪVU ZĀĻU LIETOŠANU"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value
             value="D. SĄLYGOS AR APRIBOJIMAI, SKIRTI SAUGIAM IR VEIKSMINGAM VAISTINIO PREPARATO VARTOJIMUI UŽTIKRINTI"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value
             value="D. KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TAL-UŻU SIGUR U EFFIKAĊI TAL-PRODOTT MEDIĊINALI"/>
    </designation>
    <designation>
      <language value="no"/>
      <value
             value="D. VILKÅR ELLER RESTRIKSJONER VEDRØRENDE SIKKER OG EFFEKTIV BRUK AV LEGEMIDLET"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value
             value="D. WARUNKI LUB OGRANICZENIA DOTYCZĄCE BEZPIECZNEGO I SKUTECZNEGO STOSOWANIA PRODUKTU LECZNICZEGO"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value
             value="D. CONDIÇÕES OU RESTRIÇÕES RELATIVAS À UTILIZAÇÃO SEGURA E EFICAZ DO MEDICAMENTO"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value
             value="D. CONDIȚII SAU RESTRICȚII CU PRIVIRE LA UTILIZAREA SIGURĂ ȘI EFICACE A MEDICAMENTULUI"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value
             value="D. PODMIENKY ALEBO OBMEDZENIA TÝKAJÚCE SA BEZPEČNÉHO A ÚČINNÉHO POUŽÍVANIA LIEKU"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value
             value="D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA"/>
    </designation>
    <designation>
      <language value="es"/>
      <value
             value="D. CONDICIONES O RESTRICCIONES EN RELACIÓN CON LA UTILIZACIÓN SEGURA Y EFICAZ DEL MEDICAMENTO"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value
             value="D. VILLKOR ELLER BEGRÄNSNINGAR AVSEENDE EN SÄKER OCH EFFEKTIV ANVÄNDNING AV LÄKEMEDLET"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029857"/>
    <display value="Risk management plan (RMP)"/>
    <designation>
      <language value="en"/>
      <value value="Risk management plan (RMP)"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="План за управление на риска (ПУР)"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Plan upravljanja rizikom (RMP)"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Plán řízení rizik (RMP)"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Risikostyringsplan (RMP)"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Risk Management Plan (RMP)"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Riskijuhtimiskava"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Riskienhallintasuunnitelma (RMP)"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Plan de gestion des risques (PGR)"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Risikomanagement-Plan (RMP)"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Σχέδιο διαχείρισης κινδύνου (ΣΔΚ)"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Kockázatkezelési terv"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Áætlun um áhættustjórnun"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Plean bainistithe riosca (PBR)"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Piano di gestione del rischio (RMP)"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Riska pārvaldības plāns (RPP)"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Rizikos valdymo planas (RVP)"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Pjan tal-ġestjoni tar-riskju (RMP)"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Risikohåndteringsplan (RMP)"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value
             value="Plan zarządzania ryzykiem (ang. Risk Management Plan, RMP)"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Plano de gestão do risco (PGR)"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Planul de management al riscului (PMR)"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Plán riadenia rizík (RMP)"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Načrt za obvladovanje tveganj (RMP)"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Plan de gestión de riesgos (PGR)"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Riskhanteringsplan"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029858"/>
    <display value="Additional risk minimisation measures"/>
    <designation>
      <language value="en"/>
      <value value="Additional risk minimisation measures"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Допълнителни мерки за свеждане на риска до минимум"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Dodatne mjere minimizacije rizika"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Další opatření k minimalizaci rizik"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Yderligere risikominimeringsforanstaltninger"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Extra risicobeperkende maatregelen"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Riski minimeerimise lisameetmed"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Lisätoimenpiteet riskien minimoimiseksi"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Mesures additionnelles de réduction du risque"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Zusätzliche Maßnahmen zur Risikominimierung"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Επιπρόσθετα μέτρα ελαχιστοποίησης κινδύνου"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Kockázatminimalizálásra irányuló további intézkedések"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Viðbótaraðgerðir til að lágmarka áhættu"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Bearta breise íoslaghdaithe riosca"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Misure aggiuntive di minimizzazione del rischio"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Papildu riska mazināšanas pasākumi"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Papildomos rizikos mažinimo priemonės"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Miżuri addizzjonali għall-minimizzazzjoni tar-riskji"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Andre risikominimeringsaktiviteter"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Dodatkowe działania w celu minimalizacji ryzyka"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Medidas adicionais de minimização do risco"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Măsuri suplimentare de reducere la minimum a riscului"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Nadstavbové opatrenia na minimalizáciu rizika"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Dodatni ukrepi za zmanjševanje tveganj"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Medidas adicionales de minimización de riesgos"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Ytterligare riskminimeringsåtgärder"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029859"/>
    <display value="Obligation to conduct post-authorisation measures"/>
    <designation>
      <language value="en"/>
      <value value="Obligation to conduct post-authorisation measures"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value
             value="Задължение за провеждане на мерки след разрешаване за употреба"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Obveza provođenja mjera nakon davanja odobrenja"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Povinnost uskutečnit poregistrační opatření"/>
    </designation>
    <designation>
      <language value="da"/>
      <value
             value="Forpligtelse til at gennemføre foranstaltninger efter udstedelse af markedsføringstilladelse"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value
             value="Verplichting tot het nemen van maatregelen na toekenning van de handelsvergunning"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Müügiloajärgsed kohustused"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value
             value="Velvoite toteuttaa myyntiluvan myöntämisen jälkeisiä toimenpiteitä"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value
             value="Obligation de mise en place de mesures post-autorisation"/>
    </designation>
    <designation>
      <language value="de"/>
      <value
             value="Verpflichtung zur Durchführung von Maßnahmen nach der Zulassung"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Υποχρέωση λήψης μετεγκριτικών μέτρων"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value
             value="Forgalomba hozatalt követő intézkedések teljesítésére vonatkozó speciális kötelezettség"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Skylda til aðgerða eftir útgáfu markaðsleyfis"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="An oibleagáid bearta iar-údaraithe a dhéanamh"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Obbligo di condurre attività post-autorizzative"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Saistības veikt pēcreģistrācijas pasākumus"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Įpareigojimas vykdyti poregistracines užduotis"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value
             value="Obbligu biex jitwettqu miżuri ta’ wara l-awtorizzazzjoni"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Forpliktelse til å utføre tiltak etter autorisasjon"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Zobowiązania do wypełnienia po wprowadzeniu do obrotu"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Obrigação de concretizar as medidas de pós-autorização"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Obligații pentru îndeplinirea măsurilor post-autorizare"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Povinnosť vykonať postregistračné opatrenia"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value
             value="Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Obligación de llevar a cabo medidas posautorización"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value
             value="Skyldighet att vidta åtgärder efter godkännande för försäljning"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029860"/>
    <display
             value="E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR [THE CONDITIONAL MARKETING AUTHORISATION] [THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES"/>
    <designation>
      <language value="en"/>
      <value
             value="E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR [THE CONDITIONAL MARKETING AUTHORISATION] [THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value
             value="Д. КОНКРЕТНО ЗАДЪЛЖЕНИЕ ЗА ИЗПЪЛНЕНИЕ НА МЕРКИ СЛЕД [РАЗРЕШАВАНЕ ЗА УПОТРЕБА ПОД УСЛОВИЕ] [РАЗРЕШАВАНЕ ЗА УПОТРЕБА ПРИ ИЗВЪНРЕДНИ ОБСТОЯТЕЛСТВА]"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value
             value="E. POSEBNE OBVEZE ZA PROVEDBE MJERA NAKON DAVANJA ODOBRENJA KOD [UVJETNOG ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET] [ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET U IZNIMNIM OKOLNOSTIMA]"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value
             value="E. ZVLÁŠTNÍ POVINNOST USKUTEČNIT POREGISTRAČNÍ OPATŘENÍ PRO [PODMÍNEČNOU REGISTRACI PŘÍPRAVKU] [REGISTRACI PŘÍPRAVKU ZA VÝJIMEČNÝCH OKOLNOSTÍ]"/>
    </designation>
    <designation>
      <language value="da"/>
      <value
             value="E. SÆRLIG FORPLIGTELSE TIL AT GENNEMFØRE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER GODKENDT UNDER [BETINGEDE OMSTÆNDIGHEDER] [SÆRLIGE VILKÅR]"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value
             value="E. SPECIFIEKE VERPLICHTINGEN WAARAAN NA TOEKENNING VAN EEN [VOORWAARDELIJKE VERGUNNING] [VERGUNNING ONDER UITZONDERLIJKE VOORWAARDEN] MOET WORDEN VOLDAAN"/>
    </designation>
    <designation>
      <language value="et"/>
      <value
             value="E. ERIKOHUSTUSED [TINGIMUSLIKU MÜÜGILOA] [ERANDLIKEL ASJAOLUDEL VÄLJAANTUD MÜÜGILOA] JÄRGSETE MEETMETE TÄITMISEKS"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value
             value="E. ERITYISVELVOITE TOTEUTTAA MYYNTILUVAN MYÖNTÄMISEN JÄLKEISIÄ TOIMENPITEITÄ, KUN KYSEESSÄ ON [EHDOLLINEN MYYNTILUPA] [POIKKEUSOLOSUHTEISSA MYÖNNETTY MYYNTILUPA ]"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value
             value="E. OBLIGATION SPÉCIFIQUE RELATIVE AUX MESURES POST-AUTORISATION CONCERNANT [L’AUTORISATION DE MISE SUR LE MARCHÉ CONDITIONNELLE] [L’AUTORISATION DE MISE SUR LE MARCHÉ «SOUS CIRCONSTANCES EXCEPTIONNELLES»]"/>
    </designation>
    <designation>
      <language value="de"/>
      <value
             value="E. SPEZIFISCHE VERPFLICHTUNG ZUM ABSCHLUSS VON MASSNAHMEN NACH DER ZULASSUNG [UNTER „BESONDEREN BEDINGUNGEN“] [UNTER „AUSSERGEWÖHNLICHEN UMSTÄNDEN“]"/>
    </designation>
    <designation>
      <language value="el"/>
      <value
             value="Ε. ΕΙΔΙΚΗ ΥΠΟΧΡΕΩΣΗ ΟΛΟΚΛΗΡΩΣΗΣ ΜΕΤΕΓΚΡΙΤΙΚΩΝ ΜΕΤΡΩΝ ΓΙΑ [ΤΗΝ ΑΔΕΙΑ ΚΥΚΛΟΦΟΡΙΑΣ ΜΕ ΕΓΚΡΙΣΗ ΥΠΟ ΟΡΟΥΣ] [ΤΗΝ ΑΔΕΙΑ ΚΥΚΛΟΦΟΡΙΑΣ ΥΠΟ ΕΞΑΙΡΕΤΙΚΕΣ ΠΕΡΙΣΤΑΣΕΙΣ]"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value
             value="E. KÜLÖNLEGES KÖTELEZETTSÉGVÁLLALÁS FORGALOMBA HOZATALT KÖVETŐ INTÉZKEDÉSEK TELJESÍTÉSÉRE [FELTÉTELES FORGALOMBA HOZATALI ENGEDÉLY][KIVÉTELES KÖRÜLMÉNYEK KÖZÖTT MEGADOTT FORGALOMBA HOZATALI ENGEDÉLY] ESETÉN]"/>
    </designation>
    <designation>
      <language value="is"/>
      <value
             value="E. SÉRSTÖK SKYLDA TIL AÐ LJÚKA AÐGERÐUM EFTIR ÚTGÁFU [SKILYRTS MARKAÐSLEYFIS][MARKAÐSLEYFIS SEM GEFIÐ HEFUR VERIÐ ÚT SAMKVÆMT FERLI UM UNDANTEKNINGARTILVIK]"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value
             value="E. OIBLEAGÁID SHONRACH BEARTA IAR-ÚDARAITHE A DHÉANAMH FAOI CHOINNE [ÚDARÚ MARGAÍOCHTA COINNÍOLLACH] [ÚDARÚ MARGAÍOCHTA FAOI IMTHOSCA EISCEACHTÚLA]"/>
    </designation>
    <designation>
      <language value="it"/>
      <value
             value="E. OBBLIGO SPECIFICO DI COMPLETARE LE ATTIVITA' POST-AUTORIZZATIVE PER [L’AUTORIZZAZIONE ALL’IMMISSIONE IN COMMERCIO SUBORDINATA A CONDIZIONI] [L’AUTORIZZAZIONE ALL’IMMISSIONE IN COMMERCIO RILASCIATA IN CIRCOSTANZE ECCEZIONALI]"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value
             value="E. ĪPAŠAS SAISTĪBAS, LAI VEIKTU PĒCREĢISTRĀCIJAS PASĀKUMUS [ZĀLĒM, KAS REĢISTRĒTAS AR NOSACĪJUMIEM][ZĀLĒM, KAS REĢISTRĒTAS „IZŅĒMUMA KĀRTĀ”]"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value
             value="E. SPECIFINIS ĮPAREIGOJIMAS ĮVYKDYTI POREGISTRACINES UŽDUOTIS [SĄLYGINĖS REGISTRACIJOS ATVEJU] [REGISTRACIJOS IŠIMTINĖMIS SĄLYGOMIS ATVEJU]"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value
             value="E. OBBLIGU SPEĊIFIKU BIEX MIŻURI TA’ WARA L-AWTORIZZAZJONI JIĠU KOMPLUTI GĦAL [L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ KONDIZZJONALI] [L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ TAĦT ĊIRKUSTANZI EĊĊEZZJONALI]"/>
    </designation>
    <designation>
      <language value="no"/>
      <value
             value="E. SPESIFIKK FORPLIKTELSE TIL Å FULLFØRE TILTAK ETTER AUTORISASJON FOR [DEN BETINGEDE MARKEDSFØRINGSTILLATELSEN] [MARKEDSFØRINGSTILLATELSEN GITT PÅ SÆRSKILT GRUNNLAG]"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value
             value="E. SZCZEGÓLNE ZOBOWIĄZANIA DO WYKONANIA PO WPROWADZENIU DO OBROTU, GDY POZWOLENIE NA WPROWADZENIE DO OBROTU [JEST UDZIELONE W PROCEDURZE DOPUSZCZENIA WARUNKOWEGO] [JEST UDZIELONE W PROCEDURZE DOPUSZCZENIA W WYJĄTKOWYCH OKOLICZNOŚCIACH]"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value
             value="E. OBRIGAÇÕES ESPECÍFICAS PARA COMPLETAR AS MEDIDAS DE PÓS-AUTORIZAÇÃO [DA AUTORIZAÇÃO DE INTRODUÇÃO NO MERCADO CONDICIONAL] [DA AUTORIZAÇÃO DE INTRODUÇÃO NO MERCADO EM CIRCUNSTÂNCIAS EXCECIONAIS]"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value
             value="E. OBLIGAȚII SPECIFICE PENTRU ÎNDEPLINIREA MĂSURILOR POST-AUTORIZARE ÎN CAZUL [AUTORIZĂRII PRIN APROBARE CONDIȚIONATĂ][AUTORIZĂRII ÎN CONDIȚII EXCEPȚIONALE]"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value
             value="E. OSOBITNÉ POŽIADAVKY NA SPLNENIE POSTREGISTRAČNÝCH OPATRENÍ [PRI REGISTRÁCII S PODMIENKOU] [PRI REGISTRÁCII ZA MIMORIADNYCH OKOLNOSTÍ]"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value
             value="E. 	SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI [POGOJNEGA DOVOLJENJA ZA PROMET Z ZDRAVILOM] [DOVOLJENJA ZA PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH]"/>
    </designation>
    <designation>
      <language value="es"/>
      <value
             value="E. OBLIGACIÓN ESPECÍFICA DE LLEVAR A CABO MEDIDAS POSAUTORIZACIÓN EN RELACIÓN [CON UNA AUTORIZACIÓN DE COMERCIALIZACIÓN CONDICIONAL][CON UNA AUTORIZACIÓN DE COMERCIALIZACIÓN EN CIRCUNSTANCIAS EXCEPCIONALES]"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value
             value="E. SÄRSKILDA VILLKOR SOM SKA KOMPLETTERA ÅTAGANDEN EFTER GODKÄNNANDET FÖR FÖRSÄLJNING [FÖR DET VILLKORADE GODKÄNNANDET] [FÖR GODKÄNNANDET I UNDANTAGSFALL]"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029861"/>
    <display value="LABELLING"/>
    <designation>
      <language value="en"/>
      <value value="LABELLING"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="ДАННИ ВЪРХУ ОПАКОВКАТА"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="OZNAČIVANJE"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="OZNAČENÍ NA OBALU"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="ETIKETTERING"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="ETIKETTERING"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="PAKENDI MÄRGISTUS"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="MYYNTIPÄÄLLYSMERKINNÄT"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="ÉTIQUETAGE"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="ETIKETTIERUNG"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="ΕΠΙΣΗΜΑΝΣΗ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="CÍMKESZÖVEG"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="ÁLETRANIR"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="LIPÉADÚ"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="ETICHETTATURA"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="MARĶĒJUMA TEKSTS"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="ŽENKLINIMAS"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="TIKKETTAR"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="MERKING"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="OZNAKOWANIE OPAKOWAŃ"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="ROTULAGEM"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="ETICHETAREA"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="OZNAČENIE OBALU"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="OZNAČEVANJE"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="ETIQUETADO"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="MÄRKNING"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029862"/>
    <display
             value="PARTICULARS TO APPEAR ON [THE OUTER PACKAGING] [AND] [THE IMMEDIATE PACKAGING] {NATURE/TYPE}"/>
    <designation>
      <language value="en"/>
      <value
             value="PARTICULARS TO APPEAR ON [THE OUTER PACKAGING] [AND] [THE IMMEDIATE PACKAGING] {NATURE/TYPE}"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value
             value="ДАННИ, КОИТО ТРЯБВА ДА СЪДЪРЖА [ВТОРИЧНАТА ОПАКОВКА] [И] [ПЪРВИЧНАТА ОПАКОВКА] {ВИД/ТИП}"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value
             value="PODACI KOJI SE MORAJU NALAZITI NA [ VANJSKOM PAKIRANJU] [I] [UNUTARNJEM PAKIRANJU] {VRSTA/TIP}"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value
             value="ÚDAJE UVÁDĚNÉ NA [VNĚJŠÍM OBALU] [A] [VNITŘNÍM OBALU] {DRUH/TYP}"/>
    </designation>
    <designation>
      <language value="da"/>
      <value
             value="MÆRKNING, DER SKAL ANFØRES [PÅ DEN YDRE EMBALLAGE] [OG] [PÅ DEN INDRE EMBALLAGE] {ART/TYPE}"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value
             value="GEGEVENS DIE OP [DE BUITENVERPAKKING][EN] [DE PRIMAIRE VERPAKKING] MOETEN WORDEN VERMELD {AARD/TYPE}"/>
    </designation>
    <designation>
      <language value="et"/>
      <value
             value="[VÄLISPAKENDIL] [JA] [SISEPAKENDIL] PEAVAD OLEMA JÄRGMISED ANDMED {OLEMUS/TÜÜP}"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value
             value="[ULKOPAKKAUKSESSA] [JA] [SISÄPAKKAUKSESSA] ON OLTAVA SEURAAVAT MERKINNÄT {PAKKAUSTYYPPI}"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value
             value="MENTIONS DEVANT FIGURER SUR [L’EMBALLAGE EXTÉRIEUR] [ET SUR] [LE CONDITIONNEMENT PRIMAIRE] {NATURE/TYPE}"/>
    </designation>
    <designation>
      <language value="de"/>
      <value
             value="ANGABEN [AUF DER ÄUSSEREN UMHÜLLUNG] [UND] [AUF DEM BEHÄLTNIS] {ART/TYP}"/>
    </designation>
    <designation>
      <language value="el"/>
      <value
             value="ΕΝΔΕΙΞΕΙΣ ΠΟΥ ΠΡΕΠΕΙ ΝΑ ΑΝΑΓΡΑΦΟΝΤΑΙ [ΣΤΗΝ ΕΞΩΤΕΡΙΚΗ ΣΥΣΚΕΥΑΣΙΑ] [ΚΑΙ] [ ΣΤΗ ΣΤΟΙΧΕΙΩΔΗ ΣΥΣΚΕΥΑΣΙΑ] {ΜΟΡΦΗ/ΕΙΔΟΣ}"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value
             value="A [KÜLSŐ CSOMAGOLÁSON][ÉS][A KÖZVETLEN CSOMAGOLÁSON] FELTÜNTETENDŐ ADATOK {A CSOMAGOLÁS TÍPUSA}"/>
    </designation>
    <designation>
      <language value="is"/>
      <value
             value="UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á [YTRI UMBÚÐUM] [OG] [INNRI UMBÚÐUM] {GERÐ/TEGUND}"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value
             value="SONRAÍ LE CUR AR [AN bhFORPHACÁISTÍOCHT] [AGUS] [AN NEASPHACÁISTÍOCHT] {CINEÁL}"/>
    </designation>
    <designation>
      <language value="it"/>
      <value
             value="INFORMAZIONI DA APPORRE [SUL CONFEZIONAMENTO SECONDARIO] [E] [SUL CONFEZIONAMENTO PRIMARIO] {NATURA/TIPO}"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value
             value="INFORMĀCIJA, KAS JĀNORĀDA UZ [ĀRĒJĀ IEPAKOJUMA ] [UN] [ UZ TIEŠĀ IEPAKOJUMA] {VEIDS/TIPS}"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value
             value="INFORMACIJA ANT [IŠORINĖS] [IR] [VIDINĖS] PAKUOTĖS {POBŪDIS/TIPAS}"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value
             value="TAGĦRIF LI GĦANDU JIDHER FUQ [IL-PAKKETT TA’ BARRA] [U] [IL-PAKKETT LI JMISS MAL-PRODOTT] {NATURA/TIP}"/>
    </designation>
    <designation>
      <language value="no"/>
      <value
             value="OPPLYSNINGER SOM SKAL ANGIS PÅ [YTRE EMBALLASJE][OG] [INDRE EMBALLASJE] {TYPE}"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value
             value="INFORMACJE ZAMIESZCZANE NA [OPAKOWANIACH ZEWNĘTRZNYCH] [ORAZ] [OPAKOWANIACH BEZPOŚREDNICH] {RODZAJ OPAKOWANIA}"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value
             value="INDICAÇÕES A INCLUIR [NO ACONDICIONAMENTO SECUNDÁRIO] [E] [NO ACONDICIONAMENTO PRIMÁRIO] {NATUREZA/TIPO}"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value
             value="INFORMAȚII CARE TREBUIE SĂ APARĂ PE [AMBALAJUL SECUNDAR][ȘI][AMBALAJUL PRIMAR] {NATURA/TIPUL AMBALAJULUI}"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value
             value="ÚDAJE, KTORÉ MAJÚ BYŤ UVEDENÉ NA [VONKAJŠOM OBALE] [A] [VNÚTORNOM OBALE] {DRUH/TYP}"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value
             value="PODATKI NA [ZUNANJI OVOJNINI] [IN] [PRIMARNI OVOJNINI] {VRSTA/TIP}"/>
    </designation>
    <designation>
      <language value="es"/>
      <value
             value="INFORMACIÓN QUE DEBE FIGURAR EN [EL EMBALAJE EXTERIOR][Y][EL ACONDICIONAMIENTO PRIMARIO] {NATURALEZA/TIPO}"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value
             value="UPPGIFTER SOM SKA FINNAS PÅ [YTTRE FÖRPACKNINGEN] [OCH PÅ] [INNERFÖRPACKNINGEN] {FÖRPACKNINGSTYP}"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029863"/>
    <display value="1. NAME OF THE MEDICINAL PRODUCT"/>
    <designation>
      <language value="en"/>
      <value value="1. NAME OF THE MEDICINAL PRODUCT"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="1. ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="1. NAZIV LIJEKA"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="1. NÁZEV LÉČIVÉHO PŘÍPRAVKU"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="1. LÆGEMIDLETS NAVN"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="1. NAAM VAN HET GENEESMIDDEL"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="1. RAVIMPREPARAADI NIMETUS"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="1. LÄÄKEVALMISTEEN NIMI"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="1. DÉNOMINATION DU MÉDICAMENT"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="1. BEZEICHNUNG DES ARZNEIMITTELS"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="1. ΟΝΟΜΑΣΙΑ ΤΟΥ ΦΑΡΜΑΚΕΥΤΙΚΟΥ ΠΡΟΪΟΝΤΟΣ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="1. A GYÓGYSZER NEVE"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="1. HEITI LYFS"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="1. AINM AN TÁIRGE ÍOCSHLÁINTE"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="1. DENOMINAZIONE DEL MEDICINALE"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="1. ZĀĻU NOSAUKUMS"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="1. VAISTINIO PREPARATO PAVADINIMAS"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="1. ISEM TAL-PRODOTT MEDIĊINALI"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="1. LEGEMIDLETS NAVN"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="1. NAZWA PRODUKTU LECZNICZEGO"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="1. NOME DO MEDICAMENTO"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="1. DENUMIREA COMERCIALĂ A MEDICAMENTULUI"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="1. NÁZOV LIEKU"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="1. IME ZDRAVILA"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="1. NOMBRE DEL MEDICAMENTO"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="1. LÄKEMEDLETS NAMN"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029864"/>
    <display value="2. STATEMENT OF ACTIVE SUBSTANCE(S)"/>
    <designation>
      <language value="en"/>
      <value value="2. STATEMENT OF ACTIVE SUBSTANCE(S)"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="2. ОБЯВЯВАНЕ НА АКТИВНОТО(ИТЕ) ВЕЩЕСТВО(А)"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="2. NAVOĐENJE DJELATNE(IH) TVARI"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="2. OBSAH LÉČIVÉ LÁTKY/LÉČIVÝCH LÁTEK"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="2. ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="2. GEHALTE AAN WERKZAME STOF(FEN)"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="2. TOIMEAINE(TE) SISALDUS"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="2. VAIKUTTAVA(T) AINE(ET)"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="2. COMPOSITION EN SUBSTANCE(S) ACTIVE(S)"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="2. WIRKSTOFF(E)"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="2. ΣΥΝΘΕΣΗ ΣΕ ΔΡΑΣΤΙΚΗ(ΕΣ) ΟΥΣΙΑ(ΕΣ)"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="2. HATÓANYAG(OK) MEGNEVEZÉSE"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="2. VIRK(T) EFNI"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="2. RÁITEAS FAOI NA SUBSTAINTÍ GNÍOMHACHA"/>
    </designation>
    <designation>
      <language value="it"/>
      <value
             value="2. COMPOSIZIONE QUALITATIVA E QUANTITATIVA IN TERMINI DI PRINCIPIO(I) ATTIVO(I)"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="2. AKTĪVĀS(-O) VIELAS(-U) NOSAUKUMS(-I) UN DAUDZUMS(-I)"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value
             value="2. VEIKLIOJI (-IOS) MEDŽIAGA (-OS) IR JOS (-Ų) KIEKIS (-IAI)"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="2. DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="2. DEKLARASJON AV VIRKESTOFF(ER)"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="2. ZAWARTOŚĆ [SUBSTANCJI CZYNNEJ] [SUBSTANCJI CZYNNYCH]"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="2. DESCRIÇÃO DA(S) SUBSTÂNCIA(S) ATIVA(S)"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="2. DECLARAREA SUBSTANȚEI(SUBSTANȚELOR) ACTIVE"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="2. LIEČIVO (LIEČIVÁ)"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="2. NAVEDBA ENE ALI VEČ UČINKOVIN"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="2. PRINCIPIO(S) ACTIVO(S)"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="2. DEKLARATION AV AKTIV(A) SUBSTANS(ER)"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029865"/>
    <display value="3. LIST OF EXCIPIENTS"/>
    <designation>
      <language value="en"/>
      <value value="3. LIST OF EXCIPIENTS"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="3. СПИСЪК НА ПОМОЩНИТЕ ВЕЩЕСТВА"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="3. POPIS POMOĆNIH TVARI"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="3. SEZNAM POMOCNÝCH LÁTEK"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="3. LISTE OVER HJÆLPESTOFFER"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="3. LIJST VAN HULPSTOFFEN"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="3. ABIAINED"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="3. LUETTELO APUAINEISTA"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="3. LISTE DES EXCIPIENTS"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="3. SONSTIGE BESTANDTEILE"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="3. ΚΑΤΑΛΟΓΟΣ ΕΚΔΟΧΩΝ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="3. SEGÉDANYAGOK FELSOROLÁSA"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="3. HJÁLPAREFNI"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="3. LIOSTA DE NA TÁMHÁIN"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="3. ELENCO DEGLI ECCIPIENTI"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="3. PALĪGVIELU SARAKSTS"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="3. PAGALBINIŲ MEDŽIAGŲ SĄRAŠAS"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="3. LISTA TA’ EĊĊIPJENTI"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="3. LISTE OVER HJELPESTOFFER"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="3. WYKAZ SUBSTANCJI POMOCNICZYCH"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="3. LISTA DOS EXCIPIENTES"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="3. LISTA EXCIPIENȚILOR"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="3. ZOZNAM POMOCNÝCH LÁTOK"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="3. SEZNAM POMOŽNIH SNOVI"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="3. LISTA DE EXCIPIENTES"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="3. FÖRTECKNING ÖVER HJÄLPÄMNEN"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029866"/>
    <display value="4. PHARMACEUTICAL FORM AND CONTENTS"/>
    <designation>
      <language value="en"/>
      <value value="4. PHARMACEUTICAL FORM AND CONTENTS"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="4. ЛЕКАРСТВЕНА ФОРМА И КОЛИЧЕСТВО В ЕДНА ОПАКОВКА"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="4. FARMACEUTSKI OBLIK I SADRŽAJ"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="4. LÉKOVÁ FORMA A OBSAH BALENÍ"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="4. LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE)"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="4. FARMACEUTISCHE VORM EN INHOUD"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="4. RAVIMVORM JA PAKENDI SUURUS"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="4. LÄÄKEMUOTO JA SISÄLLÖN MÄÄRÄ"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="4. FORME PHARMACEUTIQUE ET CONTENU"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="4. DARREICHUNGSFORM UND INHALT"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="4. ΦΑΡΜΑΚΟΤΕΧΝΙΚΗ ΜΟΡΦΗ ΚΑΙ ΠΕΡΙΕΧΟΜΕΝΟ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="4. GYÓGYSZERFORMA ÉS TARTALOM"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="4. LYFJAFORM OG INNIHALD"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="4. FOIRM CHÓGAISÍOCHTA AGUS INNEACHAR"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="4. FORMA FARMACEUTICA E CONTENUTO"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="4. ZĀĻU FORMA UN SATURS"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="4. FARMACINĖ FORMA IR KIEKIS PAKUOTĖJE"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="4. GĦAMLA FARMAĊEWTIKA U KONTENUT"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="4. LEGEMIDDELFORM OG INNHOLD (PAKNINGSSTØRRELSE)"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="4. POSTAĆ FARMACEUTYCZNA I ZAWARTOŚĆ OPAKOWANIA"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="4. FORMA FARMACÊUTICA E CONTEÚDO"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="4. FORMA FARMACEUTICĂ ȘI CONȚINUTUL"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="4. LIEKOVÁ FORMA A OBSAH"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="4. FARMACEVTSKA OBLIKA IN VSEBINA"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="4. FORMA FARMACÉUTICA Y CONTENIDO DEL ENVASE"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="4. LÄKEMEDELSFORM OCH FÖRPACKNINGSSTORLEK"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029867"/>
    <display value="5. METHOD AND ROUTE(S) OF ADMINISTRATION"/>
    <designation>
      <language value="en"/>
      <value value="5. METHOD AND ROUTE(S) OF ADMINISTRATION"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="5. НАЧИН НА ПРИЛОЖЕНИЕ И ПЪТ(ИЩА) НА ВЪВЕЖДАНЕ"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="5. NAČIN I PUT(EVI) PRIMJENE LIJEKA"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="5. ZPŮSOB A CESTA/CESTY PODÁNÍ"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="5. ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E)"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="5. WIJZE VAN GEBRUIK EN TOEDIENINGSWEG(EN)"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="5. MANUSTAMISVIIS JA -TEE(D)"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="5. ANTOTAPA JA TARVITTAESSA ANTOREITTI (ANTOREITIT)"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="5. MODE ET VOIE(S) D’ADMINISTRATION"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="5. HINWEISE ZUR UND ART(EN) DER ANWENDUNG"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="5. ΤΡΟΠΟΣ ΚΑΙ ΟΔΟΣ(ΟΙ) ΧΟΡΗΓΗΣΗΣ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value
             value="5. AZ ALKALMAZÁSSAL KAPCSOLATOS TUDNIVALÓK ÉS AZ ALKALMAZÁS MÓDJA(I)"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="5. AÐFERÐ VIÐ LYFJAGJÖF OG ÍKOMULEIÐ(IR)"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="5. MODH AGUS BEALACH/BEALAÍ TABHARTHA"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="5. MODO E VIA(E) DI SOMMINISTRAZIONE"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="5. LIETOŠANAS UN IEVADĪŠANAS VEIDS(-I)"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="5. VARTOJIMO METODAS IR BŪDAS (-AI)"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="5. MOD TA’ KIF U MNEJN JINGĦATA"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="5. ADMINISTRASJONSMÅTE OG -VEI(ER)"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="5. SPOSÓB I [DROGA] [DROGI] PODANIA"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="5. MODO E VIA(S) DE ADMINISTRAÇÃO"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="5. MODUL ȘI CALEA(CĂILE) DE ADMINISTRARE"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="5. SPÔSOB A CESTA (CESTY) PODÁVANIA"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="5. POSTOPEK IN POT(I) UPORABE ZDRAVILA"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="5. FORMA Y VÍA(S) DE ADMINISTRACIÓN"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="5. ADMINISTRERINGSSÄTT OCH ADMINISTRERINGSVÄG"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029868"/>
    <display
             value="6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN"/>
    <designation>
      <language value="en"/>
      <value
             value="6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value
             value="6. СПЕЦИАЛНО ПРЕДУПРЕЖДЕНИЕ, ЧЕ ЛЕКАРСТВЕНИЯТ ПРОДУКТ ТРЯБВА ДА СЕ СЪХРАНЯВА НА МЯСТО ДАЛЕЧЕ ОТ ПОГЛЕДА И ДОСЕГА НА ДЕЦА"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value
             value="6. POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN POGLEDA I DOHVATA DJECE"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value
             value="6. ZVLÁŠTNÍ UPOZORNĚNÍ, ŽE LÉČIVÝ PŘÍPRAVEK MUSÍ BÝT UCHOVÁVÁN MIMO DOHLED A DOSAH DĚTÍ"/>
    </designation>
    <designation>
      <language value="da"/>
      <value
             value="6. SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value
             value="6. EEN SPECIALE WAARSCHUWING DAT HET GENEESMIDDEL BUITEN HET ZICHT EN BEREIK VAN KINDEREN DIENT TE WORDEN GEHOUDEN"/>
    </designation>
    <designation>
      <language value="et"/>
      <value
             value="6. ERIHOIATUS, ET RAVIMIT TULEB HOIDA LASTE EEST VARJATUD JA KÄTTESAAMATUS KOHAS"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value
             value="6. ERITYISVAROITUS VALMISTEEN SÄILYTTÄMISESTÄ POISSA LASTEN ULOTTUVILTA JA NÄKYVILTÄ"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value
             value="6. MISE EN GARDE SPÉCIALE INDIQUANT QUE LE MÉDICAMENT DOIT ÊTRE CONSERVÉ HORS DE VUE ET DE PORTÉE DES ENFANTS"/>
    </designation>
    <designation>
      <language value="de"/>
      <value
             value="6. WARNHINWEIS, DASS DAS ARZNEIMITTEL FÜR KINDER UNZUGÄNGLICH AUFZUBEWAHREN IST"/>
    </designation>
    <designation>
      <language value="el"/>
      <value
             value="6. ΕΙΔΙΚΗ ΠΡΟΕΙΔΟΠΟΙΗΣΗ ΣΥΜΦΩΝΑ ΜΕ ΤΗΝ ΟΠΟΙΑ ΤΟ ΦΑΡΜΑΚΕΥΤΙΚΟ ΠΡΟΪΟΝ ΠΡΕΠΕΙ ΝΑ ΦΥΛΑΣΣΕΤΑΙ ΣΕ ΘΕΣΗ ΤΗΝ ΟΠΟΙΑ ΔΕΝ ΒΛΕΠΟΥΝ ΚΑΙ ΔΕΝ ΠΡΟΣΕΓΓΙΖΟΥΝ ΤΑ ΠΑΙΔΙΑ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value
             value="6. KÜLÖN FIGYELMEZTETÉS, MELY SZERINT A GYÓGYSZERT GYERMEKEKTŐL ELZÁRVA KELL TARTANI"/>
    </designation>
    <designation>
      <language value="is"/>
      <value
             value="6. SÉRSTÖK VARNAÐARORÐ UM AÐ LYFIÐ SKULI GEYMT ÞAR SEM BÖRN HVORKI NÁ TIL NÉ SJÁ"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value
             value="6. RABHADH SPEISIALTA GO gCAITHFEAR AN TÁIRGE ÍOCSHLÁINTE A CHOIMEÁD AS RADHARC AGUS AS AIMSIÚ LEANAÍ"/>
    </designation>
    <designation>
      <language value="it"/>
      <value
             value="6. AVVERTENZA PARTICOLARE CHE PRESCRIVA DI TENERE IL MEDICINALE FUORI DALLA VISTA E DALLA PORTATA DEI BAMBINI"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value
             value="6. ĪPAŠI BRĪDINĀJUMI PAR ZĀĻU UZGLABĀŠANU BĒRNIEM NEREDZAMĀ UN NEPIEEJAMĀ VIETĀ"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value
             value="6. SPECIALUS ĮSPĖJIMAS, KAD VAISTINĮ PREPARATĄ BŪTINA LAIKYTI VAIKAMS NEPASTEBIMOJE IR NEPASIEKIAMOJE VIETOJE"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value
             value="6. TWISSIJA SPEĊJALI LI L-PRODOTT MEDIĊINALI GĦANDU JINŻAMM FEJN MA JIDHIRX U MA JINTLAĦAQX MIT-TFAL"/>
    </designation>
    <designation>
      <language value="no"/>
      <value
             value="6. ADVARSEL OM AT LEGEMIDLET SKAL OPPBEVARES UTILGJENGELIG FOR BARN"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value
             value="6. OSTRZEŻENIE DOTYCZĄCE PRZECHOWYWANIA PRODUKTU LECZNICZEGO W MIEJSCU NIEWIDOCZNYM I NIEDOSTĘPNYM DLA DZIECI"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value
             value="6. ADVERTÊNCIA ESPECIAL DE QUE O MEDICAMENTO DEVE SER MANTIDO FORA DA VISTA E DO ALCANCE DAS CRIANÇAS"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value
             value="6. ATENȚIONARE SPECIALĂ PRIVIND FAPTUL CĂ MEDICAMENTUL NU TREBUIE PĂSTRAT LA VEDEREA ȘI ÎNDEMÂNA COPIILOR"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value
             value="6. ŠPECIÁLNE UPOZORNENIE, ŽE LIEK SA MUSÍ UCHOVÁVAŤ MIMO DOHĽADU A DOSAHU DETÍ"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value
             value="6. POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK"/>
    </designation>
    <designation>
      <language value="es"/>
      <value
             value="6. ADVERTENCIA ESPECIAL DE QUE EL MEDICAMENTO DEBE MANTENERSE FUERA DE LA VISTA Y DEL ALCANCE DE LOS NIÑOS"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value
             value="6. SÄRSKILD VARNING OM ATT LÄKEMEDLET MÅSTE FÖRVARAS UTOM SYN- OCH RÄCKHÅLL FÖR BARN"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029869"/>
    <display value="7. OTHER SPECIAL WARNING(S), IF NECESSARY"/>
    <designation>
      <language value="en"/>
      <value value="7. OTHER SPECIAL WARNING(S), IF NECESSARY"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="7. ДРУГИ СПЕЦИАЛНИ ПРЕДУПРЕЖДЕНИЯ, АКО Е НЕОБХОДИМО"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="7. DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="7. DALŠÍ ZVLÁŠTNÍ UPOZORNĚNÍ, POKUD JE POTŘEBNÉ"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="7. EVENTUELLE ANDRE SÆRLIGE ADVARSLER"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="7. ANDERE SPECIALE WAARSCHUWING(EN), INDIEN NODIG"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="7. TEISED ERIHOIATUSED (VAJADUSEL)"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value
             value="7. MUU ERITYISVAROITUS (MUUT ERITYISVAROITUKSET), JOS TARPEEN"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="7. AUTRE(S) MISE(S) EN GARDE SPÉCIALE(S), SI NÉCESSAIRE"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="7. WEITERE WARNHINWEISE, FALLS ERFORDERLICH"/>
    </designation>
    <designation>
      <language value="el"/>
      <value
             value="7. ΑΛΛΗ(ΕΣ) ΕΙΔΙΚΗ(ΕΣ) ΠΡΟΕΙΔΟΠΟΙΗΣΗ(ΕΙΣ), ΕΑΝ ΕΙΝΑΙ ΑΠΑΡΑΙΤΗΤΗ(ΕΣ)"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="7. TOVÁBBI FIGYELMEZTETÉS(EK), AMENNYIBEN SZÜKSÉGES"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="7. ÖNNUR SÉRSTÖK VARNAÐARORÐ, EF MEÐ ÞARF"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="7. RABHADH/RABHAIDH SPEISIALTA EILE, MÁS GÁ"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="7. ALTRA(E) AVVERTENZA(E) PARTICOLARE(I), SE NECESSARIO"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="7. CITI ĪPAŠI BRĪDINĀJUMI, JA NEPIECIEŠAMS"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value
             value="7. KITAS (-I) SPECIALUS (-ŪS) ĮSPĖJIMAS (-AI) (JEI REIKIA)"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="7. TWISSIJA(IET) SPEĊJALI OĦRA, JEKK MEĦTIEĠA"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="7. EVENTUELLE ANDRE SPESIELLE ADVARSLER"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="7. INNE OSTRZEŻENIA SPECJALNE, JEŚLI KONIECZNE"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="7. OUTRAS ADVERTÊNCIAS ESPECIAIS, SE NECESSÁRIO"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value
             value="7. ALTĂ(E) ATENȚIONARE(ĂRI) SPECIALĂ(E), DACĂ ESTE(SUNT) NECESARĂ(E)"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value
             value="7. INÉ ŠPECIÁLNE UPOZORNENIE (UPOZORNENIA), AK JE TO POTREBNÉ"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="7. DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="7. OTRA(S) ADVERTENCIA(S) ESPECIAL(ES), SI ES NECESARIO"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="7. ÖVRIGA SÄRSKILDA VARNINGAR OM SÅ ÄR NÖDVÄNDIGT"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029870"/>
    <display value="8. EXPIRY DATE"/>
    <designation>
      <language value="en"/>
      <value value="8. EXPIRY DATE"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="8. ДАТА НА ИЗТИЧАНЕ НА СРОКА НА ГОДНОСТ"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="8. ROK VALJANOSTI"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="8. POUŽITELNOST"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="8. UDLØBSDATO"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="8. UITERSTE GEBRUIKSDATUM"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="8. KÕLBLIKKUSAEG"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="8. VIIMEINEN KÄYTTÖPÄIVÄMÄÄRÄ"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="8. DATE DE PÉREMPTION"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="8. VERFALLDATUM"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="8. ΗΜΕΡΟΜΗΝΙΑ ΛΗΞΗΣ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="8. LEJÁRATI IDŐ"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="8. FYRNINGARDAGSETNING"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="8. DÁTA ÉAGA"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="8. DATA DI SCADENZA"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="8. DERĪGUMA TERMIŅŠ"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="8. TINKAMUMO LAIKAS"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="8. DATA TA’ SKADENZA"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="8. UTLØPSDATO"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="8. TERMIN WAŻNOŚCI"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="8. PRAZO DE VALIDADE"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="8. DATA DE EXPIRARE"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="8. DÁTUM EXSPIRÁCIE"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="8. DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="8. FECHA DE CADUCIDAD"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="8. UTGÅNGSDATUM"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029871"/>
    <display value="9. SPECIAL STORAGE CONDITIONS"/>
    <designation>
      <language value="en"/>
      <value value="9. SPECIAL STORAGE CONDITIONS"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="9. СПЕЦИАЛНИ УСЛОВИЯ НА СЪХРАНЕНИЕ"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="9. POSEBNE MJERE ČUVANJA"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="9. ZVLÁŠTNÍ PODMÍNKY PRO UCHOVÁVÁNÍ"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="9. SÆRLIGE OPBEVARINGSBETINGELSER"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="9. BIJZONDERE VOORZORGSMAATREGELEN VOOR DE BEWARING"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="9. SÄILITAMISE ERITINGIMUSED"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="9. ERITYISET SÄILYTYSOLOSUHTEET"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="9. PRÉCAUTIONS PARTICULIÈRES DE CONSERVATION"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="9. BESONDERE VORSICHTSMASSNAHMEN FÜR DIE AUFBEWAHRUNG"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="9. ΕΙΔΙΚΕΣ ΣΥΝΘΗΚΕΣ ΦΥΛΑΞΗΣ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="9. KÜLÖNLEGES TÁROLÁSI ELŐÍRÁSOK"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="9. SÉRSTÖK GEYMSLUSKILYRÐI"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="9. DÁLAÍ SPEISIALTA STÓRÁLA"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="9. PRECAUZIONI PARTICOLARI PER LA CONSERVAZIONE"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="9. ĪPAŠI UZGLABĀŠANAS NOSACĪJUMI"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="9. SPECIALIOS LAIKYMO SĄLYGOS"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="9. KONDIZZJONIJIET SPEĊJALI TA’ KIF JINĦAŻEN"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="9. OPPBEVARINGSBETINGELSER"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="9. WARUNKI PRZECHOWYWANIA"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="9. CONDIÇÕES ESPECIAIS DE CONSERVAÇÃO"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="9. CONDIȚII SPECIALE DE PĂSTRARE"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="9. ŠPECIÁLNE PODMIENKY NA UCHOVÁVANIE"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="9. POSEBNA NAVODILA ZA SHRANJEVANJE"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="9. CONDICIONES ESPECIALES DE CONSERVACIÓN"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="9. SÄRSKILDA FÖRVARINGSANVISNINGAR"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029872"/>
    <display
             value="10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE"/>
    <designation>
      <language value="en"/>
      <value
             value="10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value
             value="10. СПЕЦИАЛНИ ПРЕДПАЗНИ МЕРКИ ПРИ ИЗХВЪРЛЯНЕ НА НЕИЗПОЛЗВАНА ЧАСТ ОТ ЛЕКАРСТВЕНИТЕ ПРОДУКТИ ИЛИ ОТПАДЪЧНИ МАТЕРИАЛИ ОТ ТЯХ, АКО СЕ ИЗИСКВАТ ТАКИВА"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value
             value="10. POSEBNE MJERE ZA ZBRINJAVANJE NEISKORIŠTENOG LIJEKA ILI OTPADNIH MATERIJALA KOJI POTJEČU OD LIJEKA, AKO JE POTREBNO"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value
             value="10. ZVLÁŠTNÍ OPATŘENÍ PRO LIKVIDACI NEPOUŽITÝCH LÉČIVÝCH PŘÍPRAVKŮ NEBO ODPADU Z NICH, POKUD JE TO VHODNÉ"/>
    </designation>
    <designation>
      <language value="da"/>
      <value
             value="10. EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKE ANVENDT LÆGEMIDDEL SAMT AFFALD HERAF"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value
             value="10. BIJZONDERE VOORZORGSMAATREGELEN VOOR HET VERWIJDEREN VAN NIET-GEBRUIKTE GENEESMIDDELEN OF DAARVAN AFGELEIDE AFVALSTOFFEN (INDIEN VAN TOEPASSING)"/>
    </designation>
    <designation>
      <language value="et"/>
      <value
             value="10. ERINÕUDED KASUTAMATA JÄÄNUD RAVIMPREPARAADI VÕI SELLEST TEKKINUD JÄÄTMEMATERJALI HÄVITAMISEKS, VASTAVALT VAJADUSELE"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value
             value="10. ERITYISET VAROTOIMET KÄYTTÄMÄTTÖMIEN LÄÄKEVALMISTEIDEN TAI NIISTÄ PERÄISIN OLEVAN JÄTEMATERIAALIN HÄVITTÄMISEKSI, JOS TARPEEN"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value
             value="10. PRÉCAUTIONS PARTICULIÈRES D’ÉLIMINATION DES MÉDICAMENTS NON UTILISÉS OU DES DÉCHETS PROVENANT DE CES MÉDICAMENTS S’IL Y A LIEU"/>
    </designation>
    <designation>
      <language value="de"/>
      <value
             value="10. GEGEBENENFALLS BESONDERE VORSICHTSMASSNAHMEN FÜR DIE BESEITIGUNG VON NICHT VERWENDETEM ARZNEIMITTEL ODER DAVON STAMMENDEN ABFALLMATERIALIEN"/>
    </designation>
    <designation>
      <language value="el"/>
      <value
             value="10.	ΙΔΙΑΙΤΕΡΕΣ ΠΡΟΦΥΛΑΞΕΙΣ ΓΙΑ ΤΗΝ ΑΠΟΡΡΙΨΗ ΤΩΝ ΜΗ ΧΡΗΣΙΜΟΠΟΙΗΘΕΝΤΩΝ ΦΑΡΜΑΚΕΥΤΙΚΩΝ ΠΡΟΪΟΝΤΩΝ Ή ΤΩΝ ΥΠΟΛΕΙΜΜΑΤΩΝ ΠΟΥ ΠΡΟΕΡΧΟΝΤΑΙ ΑΠΟ ΑΥΤΑ, ΕΦΟΣΟΝ ΑΠΑΙΤΕΙΤΑΙ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value
             value="10. KÜLÖNLEGES ÓVINTÉZKEDÉSEK A FEL NEM HASZNÁLT GYÓGYSZEREK VAGY AZ ILYEN TERMÉKEKBŐL KELETKEZETT HULLADÉKANYAGOK ÁRTALMATLANNÁ TÉTELÉRE, HA ILYENEKRE SZÜKSÉG VAN"/>
    </designation>
    <designation>
      <language value="is"/>
      <value
             value="10. SÉRSTAKAR VARÚÐARRÁÐSTAFANIR VIÐ FÖRGUN LYFJALEIFA EÐA ÚRGANGS VEGNA LYFSINS ÞAR SEM VIÐ Á"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value
             value="10. RÉAMHCHÚRAIMÍ SPEISIALTA MAIDIR LE DIÚSCAIRT TÁIRGÍ ÍOCSHLÁINTE NEAMHÚSÁIDTE NÓ ÁBHAR DRAMHAÍOLA DÍORTHAITHE Ó NA TÁIRGÍ ÍOCSHLÁINTE SIN, MÁS IOMCHUÍ"/>
    </designation>
    <designation>
      <language value="it"/>
      <value
             value="10. PRECAUZIONI PARTICOLARI PER LO SMALTIMENTO DEL MEDICINALE NON UTILIZZATO O DEI RIFIUTI DERIVATI DA TALE MEDICINALE, SE NECESSARIO"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value
             value="10. ĪPAŠI PIESARDZĪBAS PASĀKUMI, IZNĪCINOT NEIZLIETOTĀS ZĀLES VAI IZMANTOTOS MATERIĀLUS, KAS BIJUŠI SASKARĒ AR ŠĪM ZĀLĒM, JA PIEMĒROJAMS"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value
             value="10. SPECIALIOS ATSARGUMO PRIEMONĖS DĖL NESUVARTOTO VAISTINIO PREPARATO AR JO ATLIEKŲ TVARKYMO (JEI REIKIA)"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value
             value="10. PREKAWZJONIJIET SPEĊJALI GĦAR-RIMI TA’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN"/>
    </designation>
    <designation>
      <language value="no"/>
      <value
             value="10. EVENTUELLE SPESIELLE FORHOLDSREGLER VED DESTRUKSJON AV UBRUKTE LEGEMIDLER ELLER AVFALL"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value
             value="10. SPECJALNE ŚRODKI OSTROŻNOŚCI DOTYCZĄCE USUWANIA NIEZUŻYTEGO PRODUKTU LECZNICZEGO LUB POCHODZĄCYCH Z NIEGO ODPADÓW, JEŚLI WŁAŚCIWE"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value
             value="10. CUIDADOS ESPECIAIS QUANTO À ELIMINAÇÃO DO MEDICAMENTO NÃO UTILIZADO OU DOS RESÍDUOS PROVENIENTES DESSE MEDICAMENTO, SE APLICÁVEL"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value
             value="10. PRECAUȚII SPECIALE PRIVIND ELIMINAREA MEDICAMENTELOR NEUTILIZATE SAU A MATERIALELOR REZIDUALE PROVENITE DIN ASTFEL DE MEDICAMENTE, DACĂ ESTE CAZUL"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value
             value="10. ŠPECIÁLNE UPOZORNENIA NA LIKVIDÁCIU NEPOUŽITÝCH LIEKOV ALEBO ODPADOV Z NICH VZNIKNUTÝCH, AK JE TO VHODNÉ"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value
             value="10. POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI"/>
    </designation>
    <designation>
      <language value="es"/>
      <value
             value="10. PRECAUCIONES ESPECIALES DE ELIMINACIÓN DEL MEDICAMENTO NO UTILIZADO Y DE LOS MATERIALES DERIVADOS DE SU USO, CUANDO CORRESPONDA"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value
             value="10. SÄRSKILDA FÖRSIKTIGHETSÅTGÄRDER FÖR DESTRUKTION AV EJ ANVÄNT LÄKEMEDEL OCH AVFALL I FÖREKOMMANDE FALL"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029873"/>
    <display
             value="11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER"/>
    <designation>
      <language value="en"/>
      <value
             value="11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value
             value="11. ИМЕ И АДРЕС НА ПРИТЕЖАТЕЛЯ НА РАЗРЕШЕНИЕТО ЗА УПОТРЕБА"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value
             value="11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="11. NÁZEV A ADRESA DRŽITELE ROZHODNUTÍ O REGISTRACI"/>
    </designation>
    <designation>
      <language value="da"/>
      <value
             value="11. NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value
             value="11. NAAM EN ADRES VAN DE HOUDER VAN DE VERGUNNING VOOR HET IN DE HANDEL BRENGEN"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="11. MÜÜGILOA HOIDJA NIMI JA AADRESS"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="11. MYYNTILUVAN HALTIJAN NIMI JA OSOITE"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value
             value="11. NOM ET ADRESSE DU TITULAIRE DE L’AUTORISATION DE MISE SUR LE MARCHÉ"/>
    </designation>
    <designation>
      <language value="de"/>
      <value
             value="11. NAME UND ANSCHRIFT DES PHARMAZEUTISCHEN UNTERNEHMERS"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="11. ΟΝΟΜΑ ΚΑΙ ΔΙΕΥΘΥΝΣΗ ΚΑΤΟΧΟΥ ΤΗΣ ΑΔΕΙΑΣ ΚΥΚΛΟΦΟΡΙΑΣ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value
             value="11. A FORGALOMBA HOZATALI ENGEDÉLY JOGOSULTJÁNAK NEVE ÉS CÍME"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="11. NAFN OG HEIMILISFANG MARKAÐSLEYFISHAFA"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value
             value="11. AINM AGUS SEOLADH SHEALBHÓIR AN ÚDARAITHE MARGAÍOCHTA"/>
    </designation>
    <designation>
      <language value="it"/>
      <value
             value="11. NOME E INDIRIZZO DEL TITOLARE DELL’AUTORIZZAZIONE ALL’IMMISSIONE IN COMMERCIO"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value
             value="11. REĢISTRĀCIJAS APLIECĪBAS ĪPAŠNIEKA NOSAUKUMS UN ADRESE"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="11. REGISTRUOTOJO PAVADINIMAS IR ADRESAS"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value
             value="11. ISEM U INDIRIZZ TAD-DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ"/>
    </designation>
    <designation>
      <language value="no"/>
      <value
             value="11. NAVN OG ADRESSE PÅ INNEHAVEREN AV MARKEDSFØRINGSTILLATELSEN"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="11. NAZWA I ADRES PODMIOTU ODPOWIEDZIALNEGO"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value
             value="11. NOME E ENDEREÇO DO TITULAR DA AUTORIZAÇÃO DE INTRODUÇÃO NO MERCADO"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value
             value="11. NUMELE ȘI ADRESA DEȚINĂTORULUI AUTORIZAȚIEI DE PUNERE PE PIAȚĂ"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="11. NÁZOV A ADRESA DRŽITEĽA ROZHODNUTIA O REGISTRÁCII"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value
             value="11. IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM"/>
    </designation>
    <designation>
      <language value="es"/>
      <value
             value="11. NOMBRE Y DIRECCIÓN DEL TITULAR DE LA AUTORIZACIÓN DE COMERCIALIZACIÓN"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value
             value="11. INNEHAVARE AV GODKÄNNANDE FÖR FÖRSÄLJNING (NAMN OCH ADRESS)"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029874"/>
    <display value="12. MARKETING AUTHORISATION NUMBER(S)"/>
    <designation>
      <language value="en"/>
      <value value="12. MARKETING AUTHORISATION NUMBER(S)"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="12. НОМЕР(А) НА РАЗРЕШЕНИЕТО ЗА УПОТРЕБА"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="12. REGISTRAČNÍ ČÍSLO/ČÍSLA"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="12. MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE)"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value
             value="12. NUMMER(S) VAN DE VERGUNNING VOOR HET IN DE HANDEL BRENGEN"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="12. MÜÜGILOA NUMBER (NUMBRID)"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="12. MYYNTILUVAN NUMERO(T)"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="12. NUMÉRO(S) D’AUTORISATION DE MISE SUR LE MARCHÉ"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="12. ZULASSUNGSNUMMER(N)"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="12. ΑΡΙΘΜΟΣ(ΟΙ) ΑΔΕΙΑΣ ΚΥΚΛΟΦΟΡΙΑΣ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="12. A FORGALOMBA HOZATALI ENGEDÉLY SZÁMA(I)"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="12. MARKAÐSLEYFISNÚMER"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="12. UIMHIR/UIMHREACHA AN ÚDARAITHE MARGAÍOCHTA"/>
    </designation>
    <designation>
      <language value="it"/>
      <value
             value="12. NUMERO(I) DELL’AUTORIZZAZIONE ALL’IMMISSIONE IN COMMERCIO"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="12. REĢISTRĀCIJAS APLIECĪBAS NUMURS(-I)"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="12. REGISTRACIJOS PAŽYMĖJIMO NUMERIS (-IAI)"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="12. NUMRU(I) TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="12. MARKEDSFØRINGSTILLATELSESNUMMER (NUMRE)"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value
             value="12. [NUMER POZWOLENIA] [NUMERY POZWOLEŃ] NA DOPUSZCZENIE DO OBROTU"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="12. NÚMERO(S) DA AUTORIZAÇÃO DE INTRODUÇÃO NO MERCADO"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="12. NUMĂRUL(ELE) AUTORIZAȚIEI DE PUNERE PE PIAȚĂ"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="12. REGISTRAČNÉ [ČÍSLO] [ČÍSLA]"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="12. ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="12. NÚMERO(S) DE AUTORIZACIÓN DE COMERCIALIZACIÓN"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="12. NUMMER PÅ GODKÄNNANDE FÖR FÖRSÄLJNING"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029875"/>
    <display value="13. BATCH NUMBER[, DONATION AND PRODUCT CODES]"/>
    <designation>
      <language value="en"/>
      <value value="13. BATCH NUMBER[, DONATION AND PRODUCT CODES]"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="13. ПАРТИДЕН НОМЕР[, КОДОВЕ НА ДАРЕНИЕТО И НА ПРОДУКТА]"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="13. BROJ SERIJE[, OZNAKE DONACIJE I PROIZVODA]"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="13. ČÍSLO ŠARŽE [, KÓD DÁRCE A KÓD LÉČIVÉHO PŘÍPRAVKU]"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="13. BATCHNUMMER [, DONATIONS- OG PRODUKTKODER]"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="13. PARTIJNUMMER[, IDENTIFICATIE- EN PRODUCTCODES]"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="13. PARTII NUMBER [ANNETUSE KOOD(ID) JA TOOTEKOOD(ID)]"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="13. ERÄNUMERO [, LUOVUTUS- JA TUOTEKOODIT]"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="13. NUMÉRO DU LOT[CODES DON ET PRODUIT]"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="13. CHARGENBEZEICHNUNG[, SPENDER- UND PRODUKTCODE]"/>
    </designation>
    <designation>
      <language value="el"/>
      <value
             value="13. ΑΡΙΘΜΟΣ ΠΑΡΤΙΔΑΣ[, ΣΤΟΙΧΕΙΑ ΔΟΤΗ ΚΑΙ ΚΩΔΙΚΟΙ ΠΡΟΪΟΝΤΟΣ]"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value
             value="13. A GYÁRTÁSI TÉTEL SZÁMA [DONÁCIÓ ÉS KÉSZÍTMÉNY KÓDJA]"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="13. LOTUNÚMER[, AUÐKENNI GJAFAR OG LYFS]"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="13. BAISCUIMHIR[, CÓD DEONAITHE AGUS CÓD TÁIRGE]"/>
    </designation>
    <designation>
      <language value="it"/>
      <value
             value="13. NUMERO DI LOTTO[, CODICI DELLA DONAZIONE E DEL PRODOTTO]"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="13. SĒRIJAS NUMURS[, DĀVINĀJUMA UN ZĀĻU KODS]"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="13. SERIJOS NUMERIS [, DONACIJA IR PREPARATO KODAI]"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="13. NUMRU TAL-LOTT [, DONAZZJONI U KOWD TAL-PRODOTT]"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="13. PRODUKSJONSNUMMER[, DONASJONS- OG PRODUKTKODER]"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="13. NUMER SERII[, KODY DONACJI I PRODUKTU]"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="13. NÚMERO DO LOTE[, CÓDIGOS DA DÁDIVA E DO PRODUTO]"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value
             value="13. SERIA DE FABRICAȚIE[, CODURILE DONAȚIEI ȘI MEDICAMENTULUI]"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="13. ČÍSLO VÝROBNEJ ŠARŽE[, KÓDY ODBERU A LIEKU]"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value
             value="13. ŠTEVILKA SERIJE[, ENOTNE OZNAKE DAROVANJA IN IZDELKOV]"/>
    </designation>
    <designation>
      <language value="es"/>
      <value
             value="13. NÚMERO DE LOTE [, CÓDIGO DE DONACIÓN Y DEL PRODUCTO]"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value
             value="13. TILLVERKNINGSSATSNUMMER [, DONATIONS- OCH PRODUKTKODER]"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029876"/>
    <display value="14. GENERAL CLASSIFICATION FOR SUPPLY"/>
    <designation>
      <language value="en"/>
      <value value="14. GENERAL CLASSIFICATION FOR SUPPLY"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="14. НАЧИН НА ОТПУСКАНЕ"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="14. NAČIN IZDAVANJA LIJEKA"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="14. KLASIFIKACE PRO VÝDEJ"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="14. GENEREL KLASSIFIKATION FOR UDLEVERING"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="14. ALGEMENE INDELING VOOR DE AFLEVERING"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="14. RAVIMI VÄLJASTAMISTINGIMUSED"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="14. YLEINEN TOIMITTAMISLUOKITTELU"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="14. CONDITIONS DE PRESCRIPTION ET DE DÉLIVRANCE"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="14. VERKAUFSABGRENZUNG"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="14. ΓΕΝΙΚΗ ΚΑΤΑΤΑΞΗ ΓΙΑ ΤΗ ΔΙΑΘΕΣΗ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value
             value="14. A GYÓGYSZER ÁLTALÁNOS BESOROLÁSA RENDELHETŐSÉG SZEMPONTJÁBÓL"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="14. AFGREIÐSLUTILHÖGUN"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="14. AICMIÚ GINEARÁLTA LE hAGHAIDH SOLÁTHAIR"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="14. CONDIZIONE GENERALE DI FORNITURA"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="14. IZSNIEGŠANAS KĀRTĪBA"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="14. PARDAVIMO (IŠDAVIMO) TVARKA"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="14. KLASSIFIKAZZJONI ĠENERALI TA’ KIF JINGĦATA"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="14. GENERELL KLASSIFIKASJON FOR UTLEVERING"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="14. OGÓLNA KATEGORIA DOSTĘPNOŚCI"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="14. CLASSIFICAÇÃO QUANTO À DISPENSA AO PÚBLICO"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="14. CLASIFICARE GENERALĂ PRIVIND MODUL DE ELIBERARE"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="14. ZATRIEDENIE LIEKU PODĽA SPÔSOBU VÝDAJA"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="14. NAČIN IZDAJANJA ZDRAVILA"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="14. CONDICIONES GENERALES DE DISPENSACIÓN"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="14. ALLMÄN KLASSIFICERING FÖR FÖRSKRIVNING"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029877"/>
    <display value="15. INSTRUCTIONS ON USE"/>
    <designation>
      <language value="en"/>
      <value value="15. INSTRUCTIONS ON USE"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="15. УКАЗАНИЯ ЗА УПОТРЕБА"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="15. UPUTE ZA UPORABU"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="15. NÁVOD K POUŽITÍ"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="15. INSTRUKTIONER VEDRØRENDE ANVENDELSEN"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="15. INSTRUCTIES VOOR GEBRUIK"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="15. KASUTUSJUHEND"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="15. KÄYTTÖOHJEET"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="15. INDICATIONS D’UTILISATION"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="15. HINWEISE FÜR DEN GEBRAUCH"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="15. ΟΔΗΓΙΕΣ ΧΡΗΣΗΣ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="15. AZ ALKALMAZÁSRA VONATKOZÓ UTASÍTÁSOK"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="15. NOTKUNARLEIÐBEININGAR"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="15. TREORACHA ÚSÁIDE"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="15. ISTRUZIONI PER L’USO"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="15. NORĀDĪJUMI PAR LIETOŠANU"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="15. VARTOJIMO INSTRUKCIJA"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="15. ISTRUZZJONIJIET DWAR L-UŻU"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="15. BRUKSANVISNING"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="15. INSTRUKCJA UŻYCIA"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="15. INSTRUÇÕES DE UTILIZAÇÃO"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="15. INSTRUCȚIUNI DE UTILIZARE"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="15. POKYNY NA POUŽITIE"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="15. NAVODILA ZA UPORABO"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="15. INSTRUCCIONES DE USO"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="15. BRUKSANVISNING"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029878"/>
    <display value="16. INFORMATION IN BRAILLE"/>
    <designation>
      <language value="en"/>
      <value value="16. INFORMATION IN BRAILLE"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="16. ИНФОРМАЦИЯ НА БРАЙЛОВА АЗБУКА"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="16. PODACI NA BRAILLEOVOM PISMU"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="16. INFORMACE V BRAILLOVĚ PÍSMU"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="16. INFORMATION I BRAILLESKRIFT"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="16. INFORMATIE IN BRAILLE"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="16. TEAVE BRAILLE’ KIRJAS (PUNKTKIRJAS)"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="16. TIEDOT PISTEKIRJOITUKSELLA"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="16. INFORMATIONS EN BRAILLE"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="16. ANGABEN IN BLINDENSCHRIFT"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="16. ΠΛΗΡΟΦΟΡΙΕΣ ΣΕ BRAILLE"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="16. BRAILLE ÍRÁSSAL FELTÜNTETETT INFORMÁCIÓK"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="16. UPPLÝSINGAR MEÐ BLINDRALETRI"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="16. FAISNÉIS IN BRAILLE"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="16. INFORMAZIONI IN BRAILLE"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="16. INFORMĀCIJA BRAILA RAKSTĀ"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="16. INFORMACIJA BRAILIO RAŠTU"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="16. INFORMAZZJONI BIL-BRAILLE"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="16. INFORMASJON PÅ BLINDESKRIFT"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="16. INFORMACJA PODANA SYSTEMEM BRAILLE’A"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="16. INFORMAÇÃO EM BRAILLE"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="16. INFORMAȚII ÎN BRAILLE"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="16. INFORMÁCIE V BRAILLOVOM PÍSME"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="16. PODATKI V BRAILLOVI PISAVI"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="16. INFORMACIÓN EN BRAILLE"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="16. INFORMATION I PUNKTSKRIFT"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029879"/>
    <display value="17. UNIQUE IDENTIFIER - 2D BARCODE"/>
    <designation>
      <language value="en"/>
      <value value="17. UNIQUE IDENTIFIER - 2D BARCODE"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="17. УНИКАЛЕН ИДЕНТИФИКАТОР — ДВУИЗМЕРЕН БАРКОД"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="17. JEDINEČNÝ IDENTIFIKÁTOR - 2D ČÁROVÝ KÓD"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="17. ENTYDIG IDENTIFIKATOR - 2D-STREGKODE"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="17. UNIEK IDENTIFICATIEKENMERK - 2D MATRIXCODE"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="17. AINULAADNE IDENTIFIKAATOR - 2D-vöötkood"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="17. YKSILÖLLINEN TUNNISTE - 2D-VIIVAKOODI"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="17. IDENTIFIANT UNIQUE - CODE-BARRES 2D"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="17. INDIVIDUELLES ERKENNUNGSMERKMAL - 2D-BARCODE"/>
    </designation>
    <designation>
      <language value="el"/>
      <value
             value="17. ΜΟΝΑΔΙΚΟΣ ΑΝΑΓΝΩΡΙΣΤΙΚΟΣ ΚΩΔΙΚΟΣ - ΔΙΣΔΙΑΣΤΑΤΟΣ ΓΡΑΜΜΩΤΟΣ ΚΩΔΙΚΑΣ (2D)"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="17. EGYEDI AZONOSÍTÓ - 2D VONALKÓD"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="17. EINKVÆMT AUÐKENNI - TVÍVÍTT STRIKAMERKI"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="17. AITHEANTÓIR UATHÚIL - BARRACHÓD 2T"/>
    </designation>
    <designation>
      <language value="it"/>
      <value
             value="17. IDENTIFICATIVO UNICO - CODICE A BARRE BIDIMENSIONALE"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="17. UNIKĀLS IDENTIFIKATORS - 2D SVĪTRKODS"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="17. UNIKALUS IDENTIFIKATORIUS - 2D BRŪKŠNINIS KODAS"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="17. IDENTIFIKATUR UNIKU - BARCODE 2D"/>
    </designation>
    <designation>
      <language value="no"/>
      <value
             value="17. SIKKERHETSANORDNING (UNIK IDENTITET) - TODIMENSJONAL STREKKODE"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="17. NIEPOWTARZALNY IDENTYFIKATOR - KOD 2D"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="17. IDENTIFICADOR ÚNICO - CÓDIGO DE BARRAS 2D"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="17. IDENTIFICATOR UNIC - COD DE BARE BIDIMENSIONAL"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="17. ŠPECIFICKÝ IDENTIFIKÁTOR - DVOJROZMERNÝ ČIAROVÝ KÓD"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="17. EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="17. IDENTIFICADOR ÚNICO - CÓDIGO DE BARRAS 2D"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value
             value="17. UNIK IDENTITETSBETECKNING – TVÅDIMENSIONELL STRECKKOD"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029880"/>
    <display value="18. UNIQUE IDENTIFIER - HUMAN READABLE DATA"/>
    <designation>
      <language value="en"/>
      <value value="18. UNIQUE IDENTIFIER - HUMAN READABLE DATA"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="18. УНИКАЛЕН ИДЕНТИФИКАТОР — ДАННИ ЗА ЧЕТЕНЕ ОТ ХОРА"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value
             value="18. JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="18. JEDINEČNÝ IDENTIFIKÁTOR - DATA ČITELNÁ OKEM"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="18. ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value
             value="18. UNIEK IDENTIFICATIEKENMERK - VOOR MENSEN LEESBARE GEGEVENS"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="18. AINULAADNE IDENTIFIKAATOR - INIMLOETAVAD ANDMED"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="18. YKSILÖLLINEN TUNNISTE - LUETTAVISSA OLEVAT TIEDOT"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value
             value="18. IDENTIFIANT UNIQUE - DONNÉES LISIBLES PAR LES HUMAINS"/>
    </designation>
    <designation>
      <language value="de"/>
      <value
             value="18. INDIVIDUELLES ERKENNUNGSMERKMAL - VOM MENSCHEN LESBARES FORMAT"/>
    </designation>
    <designation>
      <language value="el"/>
      <value
             value="18. ΜΟΝΑΔΙΚΟΣ ΑΝΑΓΝΩΡΙΣΤΙΚΟΣ ΚΩΔΙΚΟΣ - ΔΕΔΟΜΕΝΑ ΑΝΑΓΝΩΣΙΜΑ ΑΠΟ ΤΟΝ ΑΝΘΡΩΠΟ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="18. EGYEDI AZONOSÍTÓ OLVASHATÓ FORMÁTUMA"/>
    </designation>
    <designation>
      <language value="is"/>
      <value
             value="18. EINKVÆMT AUÐKENNI - UPPLÝSINGAR SEM FÓLK GETUR LESIÐ"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="18. AITHEANTÓIR UATHÚIL - SONRAÍ INLÉITE AG DUINE"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="18. IDENTIFICATIVO UNICO - DATI LEGGIBILI"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value
             value="18. UNIKĀLS IDENTIFIKATORS - DATI, KURUS VAR NOLASĪT PERSONA"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value
             value="18. UNIKALUS IDENTIFIKATORIUS - ŽMONĖMS SUPRANTAMI DUOMENYS"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="18. IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM"/>
    </designation>
    <designation>
      <language value="no"/>
      <value
             value="18. SIKKERHETSANORDNING (UNIK IDENTITET) - I ET FORMAT LESBART FOR MENNESKER"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value
             value="18. NIEPOWTARZALNY IDENTYFIKATOR - DANE CZYTELNE DLA CZŁOWIEKA"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="18. IDENTIFICADOR ÚNICO - DADOS PARA LEITURA HUMANA"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="18. IDENTIFICATOR UNIC - DATE LIZIBILE PENTRU PERSOANE"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value
             value="18. ŠPECIFICKÝ IDENTIFIKÁTOR - ÚDAJE ČITATEĽNÉ ĽUDSKÝM OKOM"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="18. EDINSTVENA OZNAKA - V BERLJIVI OBLIKI"/>
    </designation>
    <designation>
      <language value="es"/>
      <value
             value="18. IDENTIFICADOR ÚNICO - INFORMACIÓN EN CARACTERES VISUALES"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value
             value="18. UNIK IDENTITETSBETECKNING - I ETT FORMAT LÄSBART FÖR MÄNSKLIGT ÖGA"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029881"/>
    <display
             value="MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {NATURE/TYPE}"/>
    <designation>
      <language value="en"/>
      <value
             value="MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {NATURE/TYPE}"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value
             value="МИНИМУМ ДАННИ, КОИТО ТРЯБВА ДА СЪДЪРЖАТ БЛИСТЕРИТЕ И ЛЕНТИТЕ {ВИД/ТИП}"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value
             value="PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP {VRSTA/TIP}"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value
             value="MINIMÁLNÍ ÚDAJE UVÁDĚNÉ NA BLISTRECH NEBO STRIPECH {DRUH/TYP}"/>
    </designation>
    <designation>
      <language value="da"/>
      <value
             value="MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP {ART/TYPE}"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value
             value="GEGEVENS DIE IN IEDER GEVAL OP BLISTERVERPAKKINGEN OF STRIPS MOETEN WORDEN VERMELD {AARD/TYPE}"/>
    </designation>
    <designation>
      <language value="et"/>
      <value
             value="MINIMAALSED ANDMED, MIS PEAVAD OLEMA BLISTER- VÕI RIBAPAKENDIL {OLEMUS/TÜÜP}"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value
             value="LÄPIPAINOPAKKAUKSISSA TAI LEVYISSÄ ON OLTAVA VÄHINTÄÄN SEURAAVAT MERKINNÄT {PAKKAUSTYYPPI}"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value
             value="MENTIONS MINIMALES DEVANT FIGURER SUR LES PLAQUETTES OU LES FILMS THERMOSOUDÉS {NATURE/TYPE}"/>
    </designation>
    <designation>
      <language value="de"/>
      <value
             value="MINDESTANGABEN AUF BLISTERPACKUNGEN ODER FOLIENSTREIFEN {ART/TYP}"/>
    </designation>
    <designation>
      <language value="el"/>
      <value
             value="ΕΛΑΧΙΣΤΕΣ ΕΝΔΕΙΞΕΙΣ ΠΟΥ ΠΡΕΠΕΙ ΝΑ ΑΝΑΓΡΑΦΟΝΤΑΙ ΣΤΙΣ ΣΥΣΚΕΥΑΣΙΕΣ ΚΥΨΕΛΗΣ (BLISTER) Ή ΣΤΙΣ ΤΑΙΝΙΕΣ (STRIPS) {ΜΟΡΦΗ/ΕΙΔΟΣ}"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value
             value="A BUBORÉKCSOMAGOLÁSON VAGY A FÓLIACSÍKON MINIMÁLISAN FELTÜNTETENDŐ ADATOK {A CSOMAGOLÁS TÍPUSA}"/>
    </designation>
    <designation>
      <language value="is"/>
      <value
             value="LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á ÞYNNUM EÐA STRIMLUM {GERÐ/TEGUND}"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value
             value="SONRAÍ ÍOSTA LE CUR AR SPUAICPHACAÍ NÓ AR STIALLACHA {CINEÁL}"/>
    </designation>
    <designation>
      <language value="it"/>
      <value
             value="INFORMAZIONI MINIME DA APPORRE SU BLISTER O STRIP {NATURA/TIPO}"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value
             value="MINIMĀLĀ INFORMĀCIJA, KAS JĀNORĀDA UZ BLISTERA VAI PLĀKSNĪTES {VEIDS/TIPS}"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value
             value="MINIMALI INFORMACIJA ANT LIZDINIŲ PLOKŠTELIŲ ARBA DVISLUOKSNIŲ JUOSTELIŲ {POBŪDIS/TIPAS}"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value
             value="TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL-FOLJI JEW FUQ L-ISTRIXXI {NATURA/TIP}"/>
    </designation>
    <designation>
      <language value="no"/>
      <value
             value="MINSTEKRAV TIL OPPLYSNINGER SOM SKAL ANGIS PÅ BLISTER ELLER STRIP {TYPE}"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value
             value="MINIMUM INFORMACJI ZAMIESZCZANYCH NA BLISTRACH LUB OPAKOWANIACH FOLIOWYCH {RODZAJ OPAKOWANIA}"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value
             value="INDICAÇÕES MÍNIMAS A INCLUIR NAS EMBALAGENS BLISTER OU FITAS CONTENTORAS {NATUREZA/TIPO}"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value
             value="MINIMUM DE INFORMAȚII CARE TREBUIE SĂ APARĂ PE BLISTER SAU PE FOLIE TERMOSUDATĂ {NATURA/TIPUL AMBALAJULUI}"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value
             value="MINIMÁLNE ÚDAJE, KTORÉ MAJÚ BYŤ UVEDENÉ NA BLISTROCH ALEBO STRIPOCH {DRUH/TYP}"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value
             value="PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU {VRSTA/TIP}"/>
    </designation>
    <designation>
      <language value="es"/>
      <value
             value="INFORMACIÓN MÍNIMA A INCLUIR EN BLÍSTERES O TIRAS {NATURALEZA/TIPO}"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value
             value="UPPGIFTER SOM SKA FINNAS PÅ BLISTER ELLER STRIPS {FÖRPACKNINGSTYP}"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029882"/>
    <display value="1. NAME OF THE MEDICINAL PRODUCT"/>
    <designation>
      <language value="en"/>
      <value value="1. NAME OF THE MEDICINAL PRODUCT"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="1. ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="1. NAZIV LIJEKA"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="1. NÁZEV LÉČIVÉHO PŘÍPRAVKU"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="1. LÆGEMIDLETS NAVN"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="1. NAAM VAN HET GENEESMIDDEL"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="1. RAVIMPREPARAADI NIMETUS"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="1. LÄÄKEVALMISTEEN NIMI"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="1. DÉNOMINATION DU MÉDICAMENT"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="1. BEZEICHNUNG DES ARZNEIMITTELS"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="1. ΟΝΟΜΑΣΙΑ ΤΟΥ ΦΑΡΜΑΚΕΥΤΙΚΟΥ ΠΡΟΪΟΝΤΟΣ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="1. A GYÓGYSZER NEVE"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="1. HEITI LYFS"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="1. AINM AN TÁIRGE ÍOCSHLÁINTE"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="1. DENOMINAZIONE DEL MEDICINALE"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="1. ZĀĻU NOSAUKUMS"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="1. VAISTINIO PREPARATO PAVADINIMAS"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="1. ISEM IL-PRODOTT MEDIĊINALI"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="1. LEGEMIDLETS NAVN"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="1. NAZWA PRODUKTU LECZNICZEGO"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="1. NOME DO MEDICAMENTO"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="1. DENUMIREA COMERCIALĂ A MEDICAMENTULUI"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="1. NÁZOV LIEKU"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="1. IME ZDRAVILA"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="1. NOMBRE DEL MEDICAMENTO"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="1. LÄKEMEDLETS NAMN"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029883"/>
    <display value="2. NAME OF THE MARKETING AUTHORISATION HOLDER"/>
    <designation>
      <language value="en"/>
      <value value="2. NAME OF THE MARKETING AUTHORISATION HOLDER"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="2. ИМЕ НА ПРИТЕЖАТЕЛЯ НА РАЗРЕШЕНИЕТО ЗА УПОТРЕБА"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value
             value="2. NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="2. NÁZEV DRŽITELE ROZHODNUTÍ O REGISTRACI"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="2. NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value
             value="2. NAAM VAN DE HOUDER VAN DE VERGUNNING VOOR HET IN DE HANDEL BRENGEN"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="2. MÜÜGILOA HOIDJA NIMI"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="2. MYYNTILUVAN HALTIJAN NIMI"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value
             value="2. NOM DU TITULAIRE DE L’AUTORISATION DE MISE SUR LE MARCHÉ"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="2. NAME DES PHARMAZEUTISCHEN UNTERNEHMERS"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="2. ΟΝΟΜΑ ΚΑΤΟΧΟΥ ΤΗΣ ΑΔΕΙΑΣ ΚΥΚΛΟΦΟΡΙΑΣ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="2. A FORGALOMBA HOZATALI ENGEDÉLY JOGOSULTJÁNAK NEVE"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="2. NAFN MARKAÐSLEYFISHAFA"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="2. AINM SHEALBHÓIR AN ÚDARAITHE MARGAÍOCHTA"/>
    </designation>
    <designation>
      <language value="it"/>
      <value
             value="2. NOME DEL TITOLARE DELL’AUTORIZZAZIONE ALL’IMMISSIONE IN COMMERCIO"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="2. REĢISTRĀCIJAS APLIECĪBAS ĪPAŠNIEKA NOSAUKUMS"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="2. REGISTRUOTOJO PAVADINIMAS"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value
             value="2. ISEM TAD-DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="2. NAVN PÅ INNEHAVEREN AV MARKEDSFØRINGSTILLATELSEN"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="2. NAZWA PODMIOTU ODPOWIEDZIALNEGO"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value
             value="2. NOME DO TITULAR DA AUTORIZAÇÃO DE INTRODUÇÃO NO MERCADO"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="2. NUMELE DEȚINĂTORULUI AUTORIZAȚIEI DE PUNERE PE PIAȚĂ"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="2. NÁZOV DRŽITEĽA ROZHODNUTIA O REGISTRÁCII"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="2. IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM"/>
    </designation>
    <designation>
      <language value="es"/>
      <value
             value="2. NOMBRE DEL TITULAR DE LA AUTORIZACIÓN DE COMERCIALIZACIÓN"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="2. INNEHAVARE AV GODKÄNNANDE FÖR FÖRSÄLJNING"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029884"/>
    <display value="3. EXPIRY DATE"/>
    <designation>
      <language value="en"/>
      <value value="3. EXPIRY DATE"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="3. ДАТА НА ИЗТИЧАНЕ НА СРОКА НА ГОДНОСТ"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="3. ROK VALJANOSTI"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="3. POUŽITELNOST"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="3. UDLØBSDATO"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="3. UITERSTE GEBRUIKSDATUM"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="3. KÕLBLIKKUSAEG"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="3. VIIMEINEN KÄYTTÖPÄIVÄMÄÄRÄ"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="3. DATE DE PÉREMPTION"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="3. VERFALLDATUM"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="3. ΗΜΕΡΟΜΗΝΙΑ ΛΗΞΗΣ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="3. LEJÁRATI IDŐ"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="3. FYRNINGARDAGSETNING"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="3. DÁTA ÉAGA"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="3. DATA DI SCADENZA"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="3. DERĪGUMA TERMIŅŠ"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="3. TINKAMUMO LAIKAS"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="3. DATA TA’ SKADENZA"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="3. UTLØPSDATO"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="3. TERMIN WAŻNOŚCI"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="3. PRAZO DE VALIDADE"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="3. DATA DE EXPIRARE"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="3. DÁTUM EXSPIRÁCIE"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="3. DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="3. FECHA DE CADUCIDAD"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="3. UTGÅNGSDATUM"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029885"/>
    <display value="4. BATCH NUMBER[, DONATION AND PRODUCT CODES]"/>
    <designation>
      <language value="en"/>
      <value value="4. BATCH NUMBER[, DONATION AND PRODUCT CODES]"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="4. ПАРТИДЕН НОМЕР[, КОДОВЕ НА ДАРЕНИЕТО И НА ПРОДУКТА]"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="4. BROJ SERIJE[, OZNAKE DONACIJE I PROIZVODA]"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="4. ČÍSLO ŠARŽE [, KÓD DÁRCE A KÓD LÉČIVÉHO PŘÍPRAVKU]"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="4. BATCHNUMMER[, DONATIONS- OG PRODUKTKODER]"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="4. PARTIJNUMMER[, IDENTIFICATIE- EN PRODUCTCODES]"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="4. PARTII NUMBER [ANNETUSE KOOD(ID) JA TOOTEKOOD(ID)]"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="4. ERÄNUMERO [, LUOVUTUS- JA TUOTEKOODIT]"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="4. NUMÉRO DU LOT[, CODES DON ET PRODUIT]"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="4. CHARGENBEZEICHNUNG[, SPENDER- UND PRODUKTCODE]"/>
    </designation>
    <designation>
      <language value="el"/>
      <value
             value="4. ΑΡΙΘΜΟΣ ΠΑΡΤΙΔΑΣ[, ΣΤΟΙΧΕΙΑ ΔΟΤΗ ΚΑΙ ΚΩΔΙΚΟΙ ΠΡΟΪΟΝΤΟΣ]"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="4. A GYÁRTÁSI TÉTEL SZÁMA [DONÁCIÓ ÉS KÉSZÍTMÉNY KÓDJA]"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="4. LOTUNÚMER[, AUÐKENNI GJAFAR OG LYFS]"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="4. BAISCUIMHIR[, CÓD DEONAITHE AGUS CÓD TÁIRGE]"/>
    </designation>
    <designation>
      <language value="it"/>
      <value
             value="4. NUMERO DI LOTTO[, CODICI DELLA DONAZIONE E DEL PRODOTTO]"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="4. SĒRIJAS NUMURS[, DĀVINĀJUMA UN ZĀĻU KODS]"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="4. SERIJOS NUMERIS [, DONACIJA IR PREPARATO KODAI]"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="4. NUMRU TAL-LOTT [, DONAZZJONI U KOWD TAL-PRODOTT]"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="4. PRODUKSJONSNUMMER [, DONASJONS- OG PRODUKTKODER]"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="4. NUMER SERII[, KODY DONACJI I PRODUKTU]"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="4. NÚMERO DO LOTE[, CÓDIGOS DA DÁDIVA E DO PRODUTO]"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value
             value="4. SERIA DE FABRICAȚIE[, CODURILE DONAȚIEI ȘI MEDICAMENTULUI]"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="4. ČÍSLO VÝROBNEJ ŠARŽE[, KÓDY ODBERU A LIEKU]"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value
             value="4. ŠTEVILKA SERIJE[, ENOTNE OZNAKE DAROVANJA IN IZDELKOV]"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="4. NÚMERO DE LOTE [, CÓDIGO DE DONACIÓN Y DEL PRODUCTO]"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value
             value="4. TILLVERKNINGSSATSNUMMER [, DONATIONS- OCH PRODUKTKODER]"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029886"/>
    <display value="5. OTHER"/>
    <designation>
      <language value="en"/>
      <value value="5. OTHER"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="5. ДРУГО"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="5. DRUGO"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="5. JINÉ"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="5. ANDET"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="5. OVERIGE"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="5. MUU"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="5. MUUTA"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="5. AUTRE"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="5. WEITERE ANGABEN"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="5. ΑΛΛΑ ΣΤΟΙΧΕΙΑ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="5. EGYÉB INFORMÁCIÓK"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="5. ANNAÐ"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="5. EILE"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="5. ALTRO"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="5. CITA"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="5. KITA"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="5. OĦRAJN"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="5. ANNET"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="5. INNE"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="5. OUTROS"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="5. ALTE INFORMAȚII"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="5. INÉ"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="5. DRUGI PODATKI"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="5. OTROS"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="5. ÖVRIGT"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029887"/>
    <display
             value="MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {NATURE/TYPE}"/>
    <designation>
      <language value="en"/>
      <value
             value="MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {NATURE/TYPE}"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value
             value="МИНИМУМ ДАННИ, КОИТО ТРЯБВА ДА СЪДЪРЖАТ МАЛКИТЕ ЕДИНИЧНИ ПЪРВИЧНИ ОПАКОВКИ {ВИД/ТИП}"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value
             value="PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE {VRSTA/TIP}"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value
             value="MINIMÁLNÍ ÚDAJE UVÁDĚNÉ NA MALÉM VNITŘNÍM OBALU {DRUH/TYP}"/>
    </designation>
    <designation>
      <language value="da"/>
      <value
             value="MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER {ART/TYPE}"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value
             value="GEGEVENS DIE IN IEDER GEVAL OP PRIMAIRE KLEINVERPAKKINGEN MOETEN WORDEN VERMELD {AARD/TYPE}"/>
    </designation>
    <designation>
      <language value="et"/>
      <value
             value="MINIMAALSED ANDMED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL {OLEMUS/TÜÜP}"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value
             value="PIENISSÄ SISÄPAKKAUKSISSA ON OLTAVA VÄHINTÄÄN SEURAAVAT MERKINNÄT {PAKKAUSTYYPPI}"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value
             value="MENTIONS MINIMALES DEVANT FIGURER SUR LES PETITS CONDITIONNEMENTS PRIMAIRES {NATURE/TYPE}"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="MINDESTANGABEN AUF KLEINEN BEHÄLTNISSEN {ART/TYP}"/>
    </designation>
    <designation>
      <language value="el"/>
      <value
             value="ΕΛΑΧΙΣΤΕΣ ΕΝΔΕΙΞΕΙΣ ΠΟΥ ΠΡΕΠΕΙ ΝΑ ΑΝΑΓΡΑΦΟΝΤΑΙ ΣΤΙΣ ΜΙΚΡΕΣ ΣΤΟΙΧΕΙΩΔΕΙΣ ΣΥΣΚΕΥΑΣΙΕΣ {ΜΟΡΦΗ/ΕΙΔΟΣ}"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value
             value="A KIS KÖZVETLEN CSOMAGOLÁSI EGYSÉGEKEN MINIMÁLISAN FELTÜNTETENDŐ ADATOK {A CSOMAGOLÁS TÍPUSA}"/>
    </designation>
    <designation>
      <language value="is"/>
      <value
             value="LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á INNRI UMBÚÐUM LÍTILLA EININGA {GERÐ/TEGUND}"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value
             value="SONRAÍ ÍOSTA LE CUR AR AONAID BHEAGA NEASPHACÁISTÍOCHTA {CINEÁL}"/>
    </designation>
    <designation>
      <language value="it"/>
      <value
             value="INFORMAZIONI MINIME DA APPORRE SUI CONFEZIONAMENTI PRIMARI DI PICCOLE DIMENSIONI {NATURA/TIPO}"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value
             value="MINIMĀLĀ INFORMĀCIJA, KAS JĀNORĀDA UZ MAZA IZMĒRA TIEŠĀ IEPAKOJUMA {VEIDS /TIPS}"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value
             value="MINIMALI INFORMACIJA ANT MAŽŲ VIDINIŲ PAKUOČIŲ {POBŪDIS/TIPAS}"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value
             value="TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL-PAKKETTI Ż-ŻGĦAR EWLENIN {NATURA/TIP}"/>
    </designation>
    <designation>
      <language value="no"/>
      <value
             value="MINSTEKRAV TIL OPPLYSNINGER SOM SKAL ANGIS PÅ SMÅ INDRE EMBALLASJER {TYPE}"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value
             value="MINIMUM INFORMACJI ZAMIESZCZANYCH NA MAŁYCH OPAKOWANIACH BEZPOŚREDNICH {RODZAJ OPAKOWANIA}"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value
             value="INDICAÇÕES MÍNIMAS A INCLUIR EM PEQUENAS UNIDADES DE ACONDICIONAMENTO PRIMÁRIO {NATUREZA/TIPO}"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value
             value="MINIMUM DE INFORMAȚII CARE TREBUIE SĂ APARĂ PE AMBALAJELE PRIMARE MICI {NATURA/TIPUL AMBALAJULUI}"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value
             value="MINIMÁLNE ÚDAJE, KTORÉ MAJÚ BYŤ UVEDENÉ NA MALOM VNÚTORNOM OBALE {DRUH/TYP}"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value
             value="PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH {VRSTA/TIP}"/>
    </designation>
    <designation>
      <language value="es"/>
      <value
             value="INFORMACIÓN MÍNIMA QUE DEBE INCLUIRSE EN PEQUEÑOS ACONDICIONAMIENTOS PRIMARIOS {NATURALEZA/TIPO}"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value
             value="UPPGIFTER SOM SKA FINNAS PÅ SMÅ INRE LÄKEMEDELSFÖRPACKNINGAR {FÖRPACKNINGSTYP}"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029888"/>
    <display
             value="1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION"/>
    <designation>
      <language value="en"/>
      <value
             value="1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="1. ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКT И ПЪТ(ИЩА) НА ВЪВЕЖДАНЕ"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="1. NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="1. NÁZEV LÉČIVÉHO PŘÍPRAVKU A CESTA/CESTY PODÁNÍ"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="1. LÆGEMIDLETS NAVN OG ADMINISTRATIONSVEJ(E)"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="1. NAAM VAN HET GENEESMIDDEL EN DE TOEDIENINGSWEG(EN)"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="1. RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D)"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value
             value="1. LÄÄKEVALMISTEEN NIMI JA TARVITTAESSA ANTOREITTI (ANTOREITIT)"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value
             value="1. DÉNOMINATION DU MÉDICAMENT ET VOIE(S) D’ADMINISTRATION"/>
    </designation>
    <designation>
      <language value="de"/>
      <value
             value="1. BEZEICHNUNG DES ARZNEIMITTELS SOWIE ART(EN) DER ANWENDUNG"/>
    </designation>
    <designation>
      <language value="el"/>
      <value
             value="1. ΟΝΟΜΑΣΙΑ ΤΟΥ ΦΑΡΜΑΚΕΥΤΙΚΟΥ ΠΡΟΪΟΝΤΟΣ ΚΑΙ ΟΔΟΣ(ΟΙ) ΧΟΡΗΓΗΣΗΣ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="1. A GYÓGYSZER NEVE ÉS AZ ALKALMAZÁS MÓDJA(I)"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="1. HEITI LYFS OG ÍKOMULEIÐ(IR)"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value
             value="1. AINM AN TÁIRGE ÍOCSHLÁINTE AGUS BEALACH/BEALAÍ TABHARTHA"/>
    </designation>
    <designation>
      <language value="it"/>
      <value
             value="1. DENOMINAZIONE DEL MEDICINALE E VIA(E) DI SOMMINISTRAZIONE"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="1. ZĀĻU NOSAUKUMS UN IEVADĪŠANAS VEIDS(-I)"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value
             value="1. VAISTINIO PREPARATO PAVADINIMAS IR VARTOJIMO BŪDAS (-AI)"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="1. ISEM TAL-PRODOTT MEDIĊINALI U MNEJN GĦANDU JINGĦATA"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="1. LEGEMIDLETS NAVN OG ADMINISTRASJONSVEI"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="1. NAZWA PRODUKTU LECZNICZEGO I [DROGA] [DROGI] PODANIA"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="1. NOME DO MEDICAMENTO E VIA(S) DE ADMINISTRAÇÃO"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value
             value="1. DENUMIREA COMERCIALĂ A MEDICAMENTULUI ȘI CALEA(CĂILE) DE ADMINISTRARE"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="1. NÁZOV LIEKU A CESTA (CESTY) PODÁVANIA"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="1. IME ZDRAVILA IN POT(I) UPORABE"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="1. NOMBRE DEL MEDICAMENTO Y VÍA(S) DE ADMINISTRACIÓN"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="1. LÄKEMEDLETS NAMN OCH ADMINISTRERINGSVÄG"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029889"/>
    <display value="2. METHOD OF ADMINISTRATION"/>
    <designation>
      <language value="en"/>
      <value value="2. METHOD OF ADMINISTRATION"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="2. НАЧИН НА ПРИЛОЖЕНИЕ"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="2. NAČIN PRIMJENE LIJEKA"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="2. ZPŮSOB PODÁNÍ"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="2. ADMINISTRATIONSMETODE"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="2. WIJZE VAN TOEDIENING"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="2. MANUSTAMISVIIS"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="2. ANTOTAPA"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="2. MODE D’ADMINISTRATION"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="2. HINWEISE ZUR ANWENDUNG"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="2. ΤΡΟΠΟΣ ΧΟΡΗΓΗΣΗΣ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="2. AZ ALKALMAZÁSSAL KAPCSOLATOS TUDNIVALÓK"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="2. AÐFERÐ VIÐ LYFJAGJÖF"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="2. MODH TABHARTHA"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="2. MODO DI SOMMINISTRAZIONE"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="2. LIETOŠANAS VEIDS"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="2. VARTOJIMO METODAS"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="2. METODU TA’ KIF GĦANDU JINGĦATA"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="2. ADMINISTRASJONSMÅTE"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="2. SPOSÓB PODAWANIA"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="2. MODO DE ADMINISTRAÇÃO"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="2. MODUL DE ADMINISTRARE"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="2. SPÔSOB PODÁVANIA"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="2. POSTOPEK UPORABE"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="2. FORMA DE ADMINISTRACIÓN"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="2. ADMINISTRERINGSSÄTT"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029890"/>
    <display value="3. EXPIRY DATE"/>
    <designation>
      <language value="en"/>
      <value value="3. EXPIRY DATE"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="3. ДАТА НА ИЗТИЧАНЕ НА СРОКА НА ГОДНОСТ"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="3. ROK VALJANOSTI"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="3. POUŽITELNOST"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="3. UDLØBSDATO"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="3. UITERSTE GEBRUIKSDATUM"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="3. KÕLBLIKKUSAEG"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="3. VIIMEINEN KÄYTTÖPÄIVÄMÄÄRÄ"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="3. DATE DE PÉREMPTION"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="3. VERFALLDATUM"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="3. ΗΜΕΡΟΜΗΝΙΑ ΛΗΞΗΣ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="3. LEJÁRATI IDŐ"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="3. FYRNINGARDAGSETNING"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="3. DÁTA ÉAGA"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="3. DATA DI SCADENZA"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="3. DERĪGUMA TERMIŅŠ"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="3. TINKAMUMO LAIKAS"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="3. DATA TA’ SKADENZA"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="3. UTLØPSDATO"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="3. TERMIN WAŻNOŚCI"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="3. PRAZO DE VALIDADE"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="3. DATA DE EXPIRARE"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="3. DÁTUM EXSPIRÁCIE"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="3. DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="3. FECHA DE CADUCIDAD"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="3. UTGÅNGSDATUM"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029891"/>
    <display value="4. BATCH NUMBER[, DONATION AND PRODUCT CODES]"/>
    <designation>
      <language value="en"/>
      <value value="4. BATCH NUMBER[, DONATION AND PRODUCT CODES]"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="4. ПАРТИДЕН НОМЕР[, КОДОВЕ НА ДАРЕНИЕТО И НА ПРОДУКТА]"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="4. BROJ SERIJE[, OZNAKE DONACIJE I PROIZVODA]"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="4. ČÍSLO ŠARŽE [, KÓD DÁRCE A KÓD LÉČIVÉHO PŘÍPRAVKU]"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="4. BATCHNUMMER[, DONATIONS- OG PRODUKTKODER]"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="4. PARTIJNUMMER[, IDENTIFICATIE- EN PRODUCTCODES]"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="4. PARTII NUMBER [ANNETUSE KOOD(ID) JA TOOTEKOOD(ID)]"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="4. ERÄNUMERO [, LUOVUTUS- JA TUOTEKOODIT]"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="4. NUMÉRO DU LOT[, CODES DON ET PRODUIT]"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="4. CHARGENBEZEICHNUNG[, SPENDER- UND PRODUKTCODE]"/>
    </designation>
    <designation>
      <language value="el"/>
      <value
             value="4. ΑΡΙΘΜΟΣ ΠΑΡΤΙΔΑΣ[, ΣΤΟΙΧΕΙΑ ΔΟΤΗ ΚΑΙ ΚΩΔΙΚΟΙ ΠΡΟΪΟΝΤΟΣ]"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="4. A GYÁRTÁSI TÉTEL SZÁMA [DONÁCIÓ ÉS KÉSZÍTMÉNY KÓDJA]"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="4. LOTUNÚMER[, AUÐKENNI GJAFAR OG LYFS]"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="4. BAISCUIMHIR[, CÓD DEONAITHE AGUS CÓD TÁIRGE]"/>
    </designation>
    <designation>
      <language value="it"/>
      <value
             value="4. NUMERO DI LOTTO[, CODICI DELLA DONAZIONE E DEL PRODOTTO]"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="4. SĒRIJAS NUMURS[, DĀVINĀJUMA UN ZĀĻU KODS]"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="4. SERIJOS NUMERIS [, DONACIJA IR PREPARATO KODAI]"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="4. NUMRU TAL-LOTT [, DONAZZJONI U KOWD TAL-PRODOTT]"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="4. PRODUKSJONSNUMMER[, DONASJONS- OG PRODUKTKODER]"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="4. NUMER SERII[, KODY DONACJI I PRODUKTU]"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="4. NÚMERO DO LOTE[, CÓDIGOS DA DÁDIVA E DO PRODUTO]"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value
             value="4. SERIA DE FABRICAȚIE[, CODURILE DONAȚIEI ȘI MEDICAMENTULUI]"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="4. ČÍSLO VÝROBNEJ ŠARŽE[, KÓDY ODBERU A LIEKU]"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value
             value="4. ŠTEVILKA SERIJE[, ENOTNE OZNAKE DAROVANJA IN IZDELKOV]"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="4. NÚMERO DE LOTE [, CÓDIGO DE DONACIÓN Y DEL PRODUCTO]"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value
             value="4. TILLVERKNINGSSATSNUMMER [, DONATIONS- OCH PRODUKTKODER]"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029892"/>
    <display value="5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT"/>
    <designation>
      <language value="en"/>
      <value value="5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="5. СЪДЪРЖАНИЕ КАТО МАСА, ОБЕМ ИЛИ ЕДИНИЦИ"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value
             value="5. SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="5. OBSAH UDANÝ JAKO HMOTNOST, OBJEM NEBO POČET"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="5. INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ENHEDER"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="5. INHOUD UITGEDRUKT IN GEWICHT, VOLUME OF EENHEID"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="5. PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="5. SISÄLLÖN MÄÄRÄ PAINONA, TILAVUUTENA TAI YKSIKKÖINÄ"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="5. CONTENU EN POIDS, VOLUME OU UNITÉ"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="5. INHALT NACH GEWICHT, VOLUMEN ODER EINHEITEN"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="5. ΠΕΡΙΕΧΟΜΕΝΟ ΚΑΤΑ ΒΑΡΟΣ, ΚΑΤ' ΟΓΚΟ Ή ΚΑΤΑ ΜΟΝΑΔΑ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value
             value="5. A TARTALOM TÖMEGRE, TÉRFOGATRA, VAGY EGYSÉGRE VONATKOZTATVA"/>
    </designation>
    <designation>
      <language value="is"/>
      <value
             value="5. INNIHALD TILGREINT SEM ÞYNGD, RÚMMÁL EÐA FJÖLDI EININGA"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value
             value="5. INNEACHAR DE RÉIR MEÁCHAIN, DE RÉIR TOIRTE NÓ DE RÉIR AONAID"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="5. CONTENUTO IN PESO, VOLUME O UNITÀ"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="5. SATURA SVARS, TILPUMS VAI VIENĪBU DAUDZUMS"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="5. KIEKIS (MASĖ, TŪRIS ARBA VIENETAI)"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value
             value="5. IL-KONTENUT SKONT IL-PIŻ, IL-VOLUM, JEW PARTI INDIVIDWALI"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="5. INNHOLD ANGITT ETTER VEKT, VOLUM ELLER ANTALL DOSER"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value
             value="5. ZAWARTOŚĆ OPAKOWANIA Z PODANIEM MASY, OBJĘTOŚCI LUB LICZBY JEDNOSTEK"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="5. CONTEÚDO EM PESO, VOLUME OU UNIDADE"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="5. CONȚINUTUL PE MASĂ, VOLUM SAU UNITATEA DE DOZĂ"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value
             value="5. OBSAH V HMOTNOSTNÝCH, OBJEMOVÝCH ALEBO KUSOVÝCH JEDNOTKÁCH"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value
             value="5. VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="5. CONTENIDO EN PESO, EN VOLUMEN O EN UNIDADES"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="5. MÄNGD UTTRYCKT I VIKT, VOLYM ELLER PER ENHET"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029893"/>
    <display value="6. OTHER"/>
    <designation>
      <language value="en"/>
      <value value="6. OTHER"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="6. ДРУГО"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="6. DRUGO"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="6. JINÉ"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="6. ANDET"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="6. OVERIGE"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="6. MUU"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="6. MUUTA"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="6. AUTRE"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="6. WEITERE ANGABEN"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="6. ΑΛΛΑ ΣΤΟΙΧΕΙΑ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="6. EGYÉB INFORMÁCIÓK"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="6. ANNAÐ"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="6. EILE"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="6. ALTRO"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="6. CITA"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="6. KITA"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="6. OĦRAJN"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="6. ANNET"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="6. INNE"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="6. OUTROS"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="6. ALTE INFORMAȚII"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="6. INÉ"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="6. DRUGI PODATKI"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="6. OTROS"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="6. ÖVRIGT"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029894"/>
    <display value="PACKAGE LEAFLET"/>
    <designation>
      <language value="en"/>
      <value value="PACKAGE LEAFLET"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="ЛИСТОВКА"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="UPUTA O LIJEKU"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="PŘÍBALOVÁ INFORMACE"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="INDLÆGSSEDDEL"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="BIJSLUITER"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="PAKENDI INFOLEHT"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="PAKKAUSSELOSTE"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="NOTICE"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="PACKUNGSBEILAGE"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="ΦΥΛΛΟ ΟΔΗΓΙΩΝ ΧΡΗΣΗΣ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="BETEGTÁJÉKOZTATÓ"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="FYLGISEÐILL"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="BILEOG PHACÁISTE"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="FOGLIO ILLUSTRATIVO"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="LIETOŠANAS INSTRUKCIJA"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="PAKUOTĖS LAPELIS"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="FULJETT TA’ TAGĦRIF"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="PAKNINGSVEDLEGG"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="ULOTKA DLA PACJENTA"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="FOLHETO INFORMATIVO"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="PROSPECTUL"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="PÍSOMNÁ INFORMÁCIA PRE POUŽÍVATEĽA"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="NAVODILO ZA UPORABO"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="PROSPECTO"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="BIPACKSEDEL"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029895"/>
    <display value="1. What X is and what it is used for"/>
    <designation>
      <language value="en"/>
      <value value="1. What X is and what it is used for"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="1. Какво представлява Х и за какво се използва"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="1. Što je X i za što se koristi"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="1. Co je [přípravek] X a k čemu se používá"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="1. Virkning og anvendelse"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value
             value="1. Wat is X en waarvoor wordt dit middel [gebruikt][ingenomen]?"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="1. Mis ravim on X ja milleks seda kasutatakse"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="1. Mitä X on ja mihin sitä käytetään"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="1. Qu’est-ce que X et dans quels cas est-il utilisé"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="1. Was ist X und wofür wird es angewendet?"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="1. Τι είναι το Χ και ποια είναι η χρήση του"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value
             value="1. Milyen típusú gyógyszer a(z) X és milyen betegségek esetén alkalmazható?"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="1. Upplýsingar um X og við hverju það er notað"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="1. Cad é X agus cén úsáid a bhaintear as"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="1. Cos’è X e a cosa serve"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="1. Kas ir X un kādam nolūkam tās/to lieto"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="1. Kas yra X ir kam jis vartojamas"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="1. X’inhu X u gћalxiex jintuża"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="1. Hva X er og hva det brukes mot"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="1. Co to jest [lek] X i w jakim celu się go stosuje"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="1. O que é X e para que é utilizado"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="1. Ce este X și pentru ce se utilizează"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="1. Čo je X a na čo sa používa"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="1. Kaj je zdravilo X in za kaj ga uporabljamo"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="1. Qué es X y para qué se utiliza"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="1. Vad X är och vad det används för"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029896"/>
    <display value="2. What you need to know before you [take] [use] X"/>
    <designation>
      <language value="en"/>
      <value value="2. What you need to know before you [take] [use] X"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value
             value="2. Какво трябва да знаете, преди да [приемете] [използвате] Х"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value
             value="2. Što morate znati prije nego počnete [uzimati] [primjenjivati] X"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value
             value="2. Čemu musíte věnovat pozornost, než začnete [přípravek] X [užívat] [používat]"/>
    </designation>
    <designation>
      <language value="da"/>
      <value
             value="2. Det skal [De] [du] vide, før [De] [du] begynder at [tage] [bruge] [få] {X}"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value
             value="2. Wanneer mag u dit middel niet [gebruiken][innemen] of moet u er extra voorzichtig mee zijn?"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="2. Mida on vaja teada enne X’i [võtmist] [kasutamist]"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value
             value="2. Mitä sinun on tiedettävä, ennen kuin [otat] [käytät] [X:ää] [X-valmistetta]"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value
             value="2. Quelles sont les informations à connaître avant [de prendre] [d’utiliser] X"/>
    </designation>
    <designation>
      <language value="de"/>
      <value
             value="2. Was sollten Sie vor der [Einnahme] [Anwendung] von X beachten?"/>
    </designation>
    <designation>
      <language value="el"/>
      <value
             value="2. Τι πρέπει να γνωρίζετε πριν [πάρετε] [χρησιμοποιήσετε] το Χ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="2. Tudnivalók a(z) X [szedése][alkalmazása] előtt"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="2. Áður en byrjað er að nota X"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value
             value="2. An t-eolas a theastaíonn uait sula [dtóga] [n-úsáide] tú X."/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="2. Cosa deve sapere prima di [prendere] [usare] X"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="2. Kas Jums jāzina pirms X lietošanas"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="2. Kas žinotina prieš vartojant X"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="2. X'għandek tkun taf qabel ma [tieħu] [tuża] X"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="2. Hva du må vite før du bruker X"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value
             value="2. Informacje ważne przed [przyjęciem] [zastosowaniem] [leku] X"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="2. O que precisa de saber antes de [tomar] [utilizar] X"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="2. Ce trebuie să știți înainte să [luați][utilizați] X"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value
             value="2. Čo potrebujete vedieť predtým, ako [užijete] [použijete] X"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value
             value="2. Kaj morate vedeti, preden [boste vzeli] [boste uporabili] zdravilo X"/>
    </designation>
    <designation>
      <language value="es"/>
      <value
             value="2. Qué necesita saber antes de empezar a [tomar][usar] X"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="2. Vad du behöver veta innan du [tar] [använder] X"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029897"/>
    <display value="Do not [take] [use] X"/>
    <designation>
      <language value="en"/>
      <value value="Do not [take] [use] X"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Не [приемайте] [използвайте] X"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Nemojte [uzimati] [primjenjivati] X"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="[Neužívejte] [Nepoužívejte] [přípravek] X"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="[Tag] [Brug] [få] ikke {X}"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Wanneer mag u dit middel niet gebruiken?"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="X’i ei tohi [võtta] [kasutada]"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Älä [ota] [käytä] [X:ää] [X-valmistetta]"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="[Ne prenez] [N’utilisez] jamais X"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="X darf nicht [eingenommen] [angewendet] werden[,]"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Μην [πάρετε] [χρησιμοποιήσετε] το Χ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Ne [szedje][alkalmazza] a(z) X-et[:]"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Ekki má nota X"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Ná [tóg] [húsáid] X."/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Non [prenda] [usi] X"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Nelietojiet X šādos gadījumos[:]"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="X vartoti draudžiama"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="[Tiħux] [Tużax] X[:]"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Bruk ikke X[:]"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Kiedy nie [przyjmować] [stosować] [leku] X"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Não [tome] [utilize] X"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Nu [luați][utilizați] X"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="[Neužívajte] [Nepoužívajte] X"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Ne [jemljite] [uporabljajte] zdravila X"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="No [tome][use] X"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="[Ta] [Använd] inte X[:]"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029898"/>
    <display value="Warnings and precautions"/>
    <designation>
      <language value="en"/>
      <value value="Warnings and precautions"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Предупреждения и предпазни мерки"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Upozorenja i mjere opreza"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Upozornění a opatření"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Advarsler og forsigtighedsregler"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Wanneer moet u extra voorzichtig zijn met dit middel?"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Hoiatused ja ettevaatusabinõud"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Varoitukset ja varotoimet"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Avertissements et précautions"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Warnhinweise und Vorsichtsmaßnahmen"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Προειδοποιήσεις και προφυλάξεις"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Figyelmeztetések és óvintézkedések"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Varnaðarorð og varúðarreglur"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Rabhaidh agus réamhchúraimí"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Avvertenze e precauzioni"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Brīdinājumi un piesardzība lietošanā"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Įspėjimai ir atsargumo priemonės"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Twissijiet u prekawzjonijiet"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Advarsler og forsiktighetsregler"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Ostrzeżenia i środki ostrożności"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Advertências e precauções"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Atenționări și precauții"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Upozornenia a opatrenia"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Opozorila in previdnostni ukrepi"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Advertencias y precauciones"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Varningar och försiktighet"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029899"/>
    <display value="Children [and adolescents]"/>
    <designation>
      <language value="en"/>
      <value value="Children [and adolescents]"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Деца [и юноши]"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Djeca [i adolescenti]"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Děti [a dospívající]"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Børn [og unge]"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Kinderen [en jongeren tot 18 jaar]"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Lapsed [ja noorukid]"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Lapset [ja nuoret]"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Enfants [et adolescents]"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Kinder [und Jugendliche]"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Παιδιά [και έφηβοι]"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Gyermekek [és serdülők]"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Börn [og unglingar]"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Leanaí [agus ógánaigh]"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Bambini [e adolescenti]"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Bērni un [pusaudži]"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Vaikams [ir paaugliams]"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Tfal [u adolexxenti]"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Barn [og ungdom]"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Dzieci [i młodzież]"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Crianças [e adolescentes]"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Copii [și adolescenți]"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Deti [a dospievajúci]"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Otroci [in mladostniki]"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Niños [y adolescentes]"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Barn [och ungdomar]"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029900"/>
    <display value="Other medicines and X"/>
    <designation>
      <language value="en"/>
      <value value="Other medicines and X"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Други лекарства и Х"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Drugi lijekovi i X"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Další léčivé přípravky a [přípravek] X"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Brug af andre lægemidler sammen med {X}"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value
             value="[Gebruikt u nog andere geneesmiddelen?][Neemt u nog andere geneesmiddelen in?]"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Muud ravimid ja X"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Muut lääkevalmisteet ja X"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Autres médicaments et X"/>
    </designation>
    <designation>
      <language value="de"/>
      <value
             value="[Einnahme] [Anwendung] von X zusammen mit anderen Arzneimitteln"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Άλλα φάρμακα και Χ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Egyéb gyógyszerek és a(z) X"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Notkun annarra lyfja samhliða X"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Cógais eile agus X"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Altri medicinali e X"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Citas zāles un X"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Kiti vaistai ir X"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Mediċini oħra u X"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Andre legemidler og X"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="[Lek] X a inne leki"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Outros medicamentos e X"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="X împreună cu alte medicamente"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Iné lieky a X"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Druga zdravila in zdravilo X"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Otros medicamentos y X"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Andra läkemedel och X"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029901"/>
    <display value="X with [food] [and] [,] [drink] [and] [alcohol]"/>
    <designation>
      <language value="en"/>
      <value value="X with [food] [and] [,] [drink] [and] [alcohol]"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="X с [храна] [и] [,] [напитки] [и] [алкохол]"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="X s [hranom] [i] [,] [pićem] [i] [alkoholom]"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value
             value="[Přípravek] X s [jídlem] [a] [,] [pitím] [a] [alkoholem]"/>
    </designation>
    <designation>
      <language value="da"/>
      <value
             value="Brug af {X} sammen med [mad] [og] [,] [drikke] [og] [alkohol]"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value
             value="Waarop moet u letten met [eten] [en] [,] [drinken] [en] [alcohol]?"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="X koos [toidu] [ja] [,] [joogi] [ja] [alkoholiga]"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="X [ruuan] [ja] [,] [juoman] [ja] [alkoholin] kanssa"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value
             value="X avec [des aliments] [et] [,] [boissons] [et] [de l’alcool]"/>
    </designation>
    <designation>
      <language value="de"/>
      <value
             value="[Einnahme] [Anwendung] von X zusammen mit [Nahrungsmitteln] [und] [,] [Getränken] [und] [Alkohol]"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Το Χ με [τροφή] [και] [,] [ποτό] [και] [οινοπνευματώδη]"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value
             value="[Az étel] [és] [,] [az ital] [és] az alkohol hatása a(z) X-re"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Notkun X með [mat] [eða] [,] [drykk] [eða] [áfengi]"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value
             value="X in éineacht le [bia] [agus] [,] [deoch] [agus] [alcól]"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="X con [cibo] [e] [,] [bevande] [e] [alcol]"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="X kopā ar [uzturu] [un] [,] [dzērienu] [un] [alkoholu]"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value
             value="X vartojimas su [maistu] [ir] [,] [gėrimais] [ir] [alkoholiu]"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="X ma’ [ikel][u] [,] [xorb] [u] [alkoħol]"/>
    </designation>
    <designation>
      <language value="no"/>
      <value
             value="Inntak av X sammen med [mat] [og] [,] [drikke] [og] [alkohol]"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value
             value="Stosowanie leku X z [jedzeniem] [i] [,] [piciem] [i] [alkoholem]"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="X com [alimentos] [e] [,] [bebidas] [e] [álcool]"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="X împreună cu [alimente][și][,][băuturi][și][alcool]"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="X a [jedlo] [a] [,] [nápoje][a][alkohol]"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value
             value="Zdravilo X skupaj [s][z] [hrano] [in] [,] [pijačo] [in] [alkoholom]"/>
    </designation>
    <designation>
      <language value="es"/>
      <value
             value="[Uso][Toma] de X con [alimentos][y][,][bebidas][y][alcohol]"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="X med [mat] [och ] [,] [dryck] [och] [alkohol]"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029902"/>
    <display value="Pregnancy [and] [,] breast-feeding [and fertility]"/>
    <designation>
      <language value="en"/>
      <value value="Pregnancy [and] [,] breast-feeding [and fertility]"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Бременност [и] [,] кърмене [и фертилитет]"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Trudnoća [i] [,] dojenje [i plodnost]"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Těhotenství [a] [,] kojení [a plodnost]"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Graviditet [og] [,] amning [og frugtbarhed]"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Zwangerschap [en] [,] borstvoeding [en vruchtbaarheid]"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Rasedus [ja] [,] imetamine [ja viljakus]"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Raskaus [ja] [,] imetys [ja hedelmällisyys]"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Grossesse [et] [,] allaitement [et fertilité]"/>
    </designation>
    <designation>
      <language value="de"/>
      <value
             value="Schwangerschaft [und] [,] Stillzeit [und Fortpflanzungsfähigkeit]"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Κύηση[,] [και] θηλασμός [και γονιμότητα]"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Terhesség [és][,] szoptatás [ és termékenység]"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Meðganga [og] [,] brjóstagjöf [og frjósemi]"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Toircheas [agus] [,] beathú cíche [agus torthúlacht]"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Gravidanza [e] [,] allattamento [e fertilità]"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Grūtniecība [un] [,] barošana ar krūti [un fertilitāte]"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Nėštumas [ir] [,] žindymo laikotarpis [ir vaisingumas]"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Tqala [u] [,] treddigħ [u fertilità]"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Graviditet [og] [,] amming [og fertilitet]"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Ciąża [i] [,] karmienie piersią [i wpływ na płodność]"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Gravidez [e] [,] amamentação [e fertilidade]"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Sarcina [și][,] alăptarea [și fertilitatea]"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Tehotenstvo [a] [dojčenie] [a plodnosť]"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Nosečnost [in] [,] dojenje [in plodnost]"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Embarazo [y][,] lactancia [y fertilidad]"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Graviditet [och] [,] amning [och fertilitet]"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029903"/>
    <display value="Driving and using machines"/>
    <designation>
      <language value="en"/>
      <value value="Driving and using machines"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Шофиране и работа с машини"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Upravljanje vozilima i strojevima"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Řízení dopravních prostředků a obsluha strojů"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Trafik- og arbejdssikkerhed"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Rijvaardigheid en het gebruik van machines"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Autojuhtimine ja masinatega töötamine"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Ajaminen ja koneiden käyttö"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Conduite de véhicules et utilisation de machines"/>
    </designation>
    <designation>
      <language value="de"/>
      <value
             value="Verkehrstüchtigkeit und Fähigkeit zum Bedienen von Maschinen"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Οδήγηση και χειρισμός μηχανημάτων"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value
             value="A készítmény hatásai a gépjárművezetéshez és a gépek kezeléséhez szükséges képességekre"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Akstur og notkun véla"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Tiomáint agus meaisíní a úsáid"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Guida di veicoli e utilizzo di macchinari"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Transportlīdzekļu vadīšana un mehānismu apkalpošana"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Vairavimas ir mechanizmų valdymas"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Sewqan u tħaddim ta’ magni"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Kjøring og bruk av maskiner"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Prowadzenie pojazdów i obsługiwanie maszyn"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Condução de veículos e utilização de máquinas"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Conducerea vehiculelor și folosirea utilajelor"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Vedenie vozidiel a obsluha strojov"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Vpliv na sposobnost upravljanja vozil in strojev"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Conducción y uso de máquinas"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Körförmåga och användning av maskiner"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029904"/>
    <display value="X contains {name the excipient(s)}"/>
    <designation>
      <language value="en"/>
      <value value="X contains {name the excipient(s)}"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="X съдържа {име на помощното(ите) вещество(а)}"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="X sadrži {naziv pomoćne(ih) tvari}"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value
             value="Přípravek] X obsahuje {název pomocné látky/pomocných látek}"/>
    </designation>
    <designation>
      <language value="da"/>
      <value
             value="{X} indeholder {nævn de(t) hjælpestof(fer), hvor advarsel er påkrævet}"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="X bevat {naam van de hulpstof(fen)}"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="X sisaldab {abiaine(te) nimetus}"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="X sisältää {apuaineen(apuaineiden) nimi(nimet)}"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="X contient {nommer le/les excipient(s)}"/>
    </designation>
    <designation>
      <language value="de"/>
      <value
             value="X enthält {Bezeichnung [des] [der] sonstigen Bestandteil(s)(e)}"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Το Χ περιέχει {όνομα(τα) εκδόχου(ων)}"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="A(z) X {segédanyag(ok) neve}-t tartalmaz"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="X inniheldur {tilgreinið viðkomandi hjálparefni}"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Tá {ainm an támháin/na dtámhán} in X"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="X contiene {nome del(degli) eccipiente(i)}"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="X satur {palīgvielas(-u) nosaukums(-i)}"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value
             value="X sudėtyje yra {pagalbinės (-ių) medžiagos (-ų) pavadinimas (-ai)}"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="X fih {isem tas-sustanza(i) mhux attiva(i)}"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="X inneholder {navn på hjelpestoff(er)}"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value
             value="[Lek] X zawiera {[nazwa substancji pomocniczej] [nazwy substancji pomocniczych]}"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="X contém {nome do(s) excipiente(s)}"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="X conține {numele excipientului(ților)}"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="X obsahuje {názov pomocnej látky(pomocných látok)}"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Zdravilo X vsebuje {ime pomožne(ih) snovi}"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="X contiene {nombre del (de los) excipiente(s)}"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="X innehåller {namn på hjälpämne(n)}"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029905"/>
    <display value="3. How to [take] [use] X"/>
    <designation>
      <language value="en"/>
      <value value="3. How to [take] [use] X"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="3. Как да [приемате] [използвате] Х"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="3. Kako [uzimati] [primjenjivati] X"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="3. Jak se [přípravek] X [užívá] [používá]"/>
    </designation>
    <designation>
      <language value="da"/>
      <value
             value="3. Sådan skal [De] [du] [tage] [bruge] {X} / Sådan får [De] [du] {X}"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="3. Hoe [gebruikt u dit middel][neemt u dit middel in]?"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="3. Kuidas X’i [võtta] [kasutada]"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="3. Miten [X:ää] [X-valmistetta] [otetaan] [käytetään]"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="3. Comment [prendre] [utiliser] X"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="3. Wie ist X [einzunehmen] [anzuwenden]?"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="3. Πώς να [πάρετε] [χρησιμοποιήσετε] το Χ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="3. Hogyan kell [szedni][alkalmazni] a(z) X-et?"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="3. Hvernig nota á X"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="3. Conas X a [thógáil] [úsáid]."/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="3. Come [prendere] [usare] X"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="3. Kā lietot X"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="3. Kaip vartoti X"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="3. Kif gћandek [tieћu][tuża] X"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="3. Hvordan du bruker X"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="3. Jak [przyjmować] [stosować] [lek] X"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="3. Como [tomar] [utilizar] X"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="3. Cum să [luați][utilizați] X"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="3. Ako [užívať] [používať] X"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="3. Kako [jemati] [uporabljati] zdravilo X"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="3. Cómo [tomar][usar] X"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="3. Hur du [tar] [använder] X"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029906"/>
    <display value="Use in children [and adolescents]"/>
    <designation>
      <language value="en"/>
      <value value="Use in children [and adolescents]"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Употреба при деца [и юноши]"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Primjena u djece [i adolescenata]"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Použití u dětí [a dospívajících]"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Brug til børn [og unge]"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Gebruik bij kinderen [en jongeren tot 18 jaar]"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Kasutamine lastel [ja noorukitel]"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Käyttö lapsille [ja nuorille]"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Utilisation chez les enfants [et les adolescents]"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Anwendung bei Kindern [und Jugendlichen]"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Χρήση σε παιδιά] [και εφήβους]"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Alkalmazása gyermekeknél [és serdülőknél]"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Notkun handa börnum [og unglingum]"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Úsáid le leanaí [agus le hógánaigh]"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Uso nei bambini [e negli adolescenti]"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Lietošana bērniem [un pusaudžiem]"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Vartojimas vaikams [ir paaugliams]"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Użu fit-tfal [u fl-adolexxenti]"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Bruk hos barn [og ungdom]"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Stosowanie u dzieci [i młodzieży]"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Utilização em crianças [e adolescentes]"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Utilizarea la copii [și adolescenți]"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Použitie u detí [a dospievajúcich]"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Uporaba pri otrocih [in mladostnikih]"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Uso en niños [y adolescentes]"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Användning för barn [och ungdomar]"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029907"/>
    <display value="If you [take] [use] more X than you should"/>
    <designation>
      <language value="en"/>
      <value value="If you [take] [use] more X than you should"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value
             value="Ако сте [приели] [използвали] повече от необходимата доза X"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Ako [uzmete] [primijenite] više X nego što ste trebali"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value
             value="Jestliže jste [užil(a)] [použil(a)] více [přípravku]X, než jste měl(a)"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Hvis [De] [du] har [taget] [brugt] [fået] for meget {X}"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Heeft u te veel van dit middel [gebruikt] [ingenomen]?"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Kui te [võtate] [kasutate] X’i rohkem, kui ette nähtud"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value
             value="Jos [otat] [käytät] enemmän [X:ää] [X-valmistetta] kuin sinun pitäisi"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value
             value="Si vous avez [pris] [utilisé] plus de X que vous n’auriez dû"/>
    </designation>
    <designation>
      <language value="de"/>
      <value
             value="Wenn Sie eine größere Menge von X [eingenommen] [angewendet] haben, als Sie sollten"/>
    </designation>
    <designation>
      <language value="el"/>
      <value
             value="Εάν [πάρετε] [χρησιμοποιήσετε] μεγαλύτερη δόση Χ από την κανονική"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Ha az előírtnál több X-et [vett be][alkalmazott]"/>
    </designation>
    <designation>
      <language value="is"/>
      <value
             value="Ef [tekinn] [notaður] er stærri skammtur en mælt er fyrir um"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Má [thóg] [d’úsáid] tú níos mó X ná mar ba chóir duit"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Se [prende] [usa] più X di quanto deve"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Ja esat lietojis X vairāk nekā noteikts"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Ką daryti pavartojus per didelę X dozę?"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Jekk [tieħu] [tuża] X aktar milli suppost"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Dersom du tar for mye av X"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value
             value="[Przyjęcie] [Zastosowanie] większej niż zalecana dawki [leku] X"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Se [tomar] [utilizar] mais X do que deveria"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Dacă [luați][utilizați] mai mult X decât trebuie"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Ak [užijete] [použijete] viac X, ako máte"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value
             value="Če ste [vzeli] [uporabili] večji odmerek zdravila X, kot bi smeli"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Si [toma][usa] más X del que debe"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Om du [har tagit] [använt] för stor mängd av X"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029908"/>
    <display value="If you forget to [take] [use] X"/>
    <designation>
      <language value="en"/>
      <value value="If you forget to [take] [use] X"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Ако сте пропуснали да [приемете] [използвате] X"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Ako ste zaboravili [uzeti] [primijeniti] X"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Jestliže jste zapomněl(a) [užít] [použít] [přípravek]X"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Hvis [De] [du] har glemt at [tage] [bruge] [få] {X}"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value
             value="Bent u vergeten dit middel [te gebruiken] [in te nemen]?"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Kui te unustate X’i [võtta] [kasutada]"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Jos unohdat [ottaa] [käyttää] [X:ää] [X-valmistetta]"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Si vous oubliez [de prendre] [d’utiliser] X"/>
    </designation>
    <designation>
      <language value="de"/>
      <value
             value="Wenn Sie die [Einnahme] [Anwendung] von X vergessen haben"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Εάν ξεχάσετε να [πάρετε] [χρησιμοποιήσετε] το Χ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Ha elfelejtette [bevenni][alkalmazni] a(z) X-et"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Ef gleymist að [taka] [nota] X"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Má dhéanann tú dearmad X a [thógáil] [úsáid]"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Se dimentica di [prendere] [usare] X"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Ja esat aizmirsis lietot X"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Pamiršus pavartoti X"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Jekk tinsa [tieħu] [tuża] X"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Dersom du har glemt å ta X"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Pominięcie [przyjęcia] [zastosowania] [leku] X"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Caso se tenha esquecido de [tomar] [utilizar] X"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Dacă uitați să [luați][utilizați] X"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Ak zabudnete [užiť] [použiť] X"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Če ste pozabili [vzeti] [uporabiti] zdravilo X"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Si olvidó [tomar][usar] X"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Om du har glömt att [ta] [använda] X"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029909"/>
    <display value="If you stop [taking] [using] X"/>
    <designation>
      <language value="en"/>
      <value value="If you stop [taking] [using] X"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Ако сте спрели [приема] [употребата] на X"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Ako prestanete [uzimati] [primjenjivati] X"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value
             value="Jestliže jste přestal(a) [užívat] [používat] [přípravek]X"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Hvis [De] [du] holder op med at [tage] [bruge] [få] {X}"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Als u stopt met het [innemen] [gebruik] van dit middel"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Kui te lõpetate X’i [võtmise] [kasutamise]"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Jos lopetat [X:n] [X-valmisteen] [oton] [käytön]"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Si vous arrêtez [de prendre] [d’utiliser] X"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Wenn Sie die [Einnahme] [Anwendung] von X abbrechen"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Εάν σταματήσετε να [παίρνετε] [χρησιμοποιείτε] το Χ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Ha idő előtt abbahagyja a(z) X [szedését][alkalmazását]"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Ef hætt er að nota X"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Má stopann tú de X a [thógáil] [úsáid]"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Se interrompe il trattamento con X"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Ja pārtraucat lietot X"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Nustojus vartoti X"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Jekk tieqaf [tieħu] [tuża] X"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Dersom du avbryter behandling med X"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Przerwanie [przyjmowania] [stosowania] [leku] X"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Se parar de [tomar] [utilizar] X"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Dacă încetați să [luați][utilizați] X"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Ak prestanete [užívať] [používať] X"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Če ste prenehali [jemati] [uporabljati] zdravilo X"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Si interrumpe el tratamiento con X"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Om du slutar att [ta] [använda]X"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029910"/>
    <display value="4. Possible side effects"/>
    <designation>
      <language value="en"/>
      <value value="4. Possible side effects"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="4. Възможни нежелани реакции"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="4. Moguće nuspojave"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="4. Možné nežádoucí účinky"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="4. Bivirkninger"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="4. Mogelijke bijwerkingen"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="4. Võimalikud kõrvaltoimed"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="4. Mahdolliset haittavaikutukset"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="4. Quels sont les effets indésirables éventuels?"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="4. Welche Nebenwirkungen sind möglich?"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="4. Πιθανές ανεπιθύμητες ενέργειες"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="4. Lehetséges mellékhatások"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="4. Hugsanlegar aukaverkanir"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="4. Fo-iarsmaí féideartha"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="4. Possibili effetti indesiderati"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="4. Iespējamās blakusparādības"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="4. Galimas šalutinis poveikis"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="4. Effetti sekondarji possibbli"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="4. Mulige bivirkninger"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="4. Możliwe działania niepożądane"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="4. Efeitos indesejáveis possíveis"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="4. Reacții adverse posibile"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="4. Možné vedľajšie účinky"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="4. Možni neželeni učinki"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="4. Posibles efectos adversos"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="4. Eventuella biverkningar"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029911"/>
    <display value="Additional side effects in children [and adolescents]"/>
    <designation>
      <language value="en"/>
      <value value="Additional side effects in children [and adolescents]"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Допълнителни нежелани реакции при деца [и юноши]"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Dodatne nuspojave u djece [i adolescenata]"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Další nežádoucí účinky u dětí [a dospívajících]"/>
    </designation>
    <designation>
      <language value="da"/>
      <value
             value="Hos børn [og unge] kan endvidere ses følgende bivirkninger:"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value
             value="Extra bijwerkingen die bij kinderen [en jongeren tot 18 jaar] kunnen voorkomen"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Täiendavad kõrvaltoimed lastel [ja noorukitel]"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Muut haittavaikutukset lapsilla [ja nuorilla]"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value
             value="Effets indésirables supplémentaires chez les enfants [et les adolescents]"/>
    </designation>
    <designation>
      <language value="de"/>
      <value
             value="Zusätzliche Nebenwirkungen bei Kindern [und Jugendlichen]"/>
    </designation>
    <designation>
      <language value="el"/>
      <value
             value="Συμπληρωματικές ανεπιθύμητες ενέργειες σε παιδιά [και εφήβους]"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="További mellékhatások gyermekeknél [és serdülőknél]"/>
    </designation>
    <designation>
      <language value="is"/>
      <value
             value="Aðrar aukaverkanir sem geta komið fyrir hjá börnum [og unglingum]"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Fo-iarsmaí breise i leanaí [agus in ógánaigh]"/>
    </designation>
    <designation>
      <language value="it"/>
      <value
             value="Effetti indesiderati aggiuntivi nei bambini [e negli adolescenti]"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Papildu blakusparādības bērniem [un pusaudžiem]"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value
             value="Kitas šalutinis poveikis, kuris gali pasireikšti vaikams [ir paaugliams]"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Effetti sekondarji oħra fit-tfal [u l-adolexxenti]"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Bivirkninger som kan forekomme hos barn [og ungdom]"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Dodatkowe działania niepożądane u dzieci [i młodzieży]"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value
             value="Efeitos indesejáveis adicionais em crianças [e adolescentes]"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Reacții adverse suplimentare la copii [și adolescenți]"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Ďalšie vedľajšie účinky u detí [a dospievajúcich]"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Dodatni neželeni učinki pri otrocih [in mladostnikih]"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Otros efectos adversos en niños [y adolescentes]"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Ytterligare biverkningar hos barn [och ungdomar]"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029912"/>
    <display value="Reporting of side effects"/>
    <designation>
      <language value="en"/>
      <value value="Reporting of side effects"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Съобщаване на нежелани реакции"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Prijavljivanje nuspojava"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Hlášení nežádoucích účinků"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Indberetning af bivirkninger"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Het melden van bijwerkingen"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Kõrvaltoimetest teatamine"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Haittavaikutuksista ilmoittaminen"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Déclaration des effets secondaires"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Meldung von Nebenwirkungen"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Αναφορά ανεπιθύμητων ενεργειών"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Mellékhatások bejelentése"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Tilkynning aukaverkana"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Fo-iarsmaí a thuairisciú"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Segnalazione degli effetti indesiderati"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Ziņošana par blakusparādībām"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Pranešimas apie šalutinį poveikį"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Rappurtar tal-effetti sekondarji"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Melding av bivirkninger"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Zgłaszanie działań niepożądanych"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Comunicação de efeitos indesejáveis"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Raportarea reacțiilor adverse"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Hlásenie vedľajších účinkov"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Poročanje o neželenih učinkih"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Comunicación de efectos adversos"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Rapportering av biverkningar"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029913"/>
    <display value="5. How to store X"/>
    <designation>
      <language value="en"/>
      <value value="5. How to store X"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="5. Как да съхранявате X"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="5. Kako čuvati X"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="5. Jak [přípravek] X uchovávat"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="5. Opbevaring"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="5. Hoe bewaart u dit middel?"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="5. Kuidas X’i säilitada"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="5. [X:n] [X-valmisteen] säilyttäminen"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="5. Comment conserver X"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="5. Wie ist X aufzubewahren?"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="5. Πώς να φυλάσσετε το Χ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="5. Hogyan kell a(z) X-et tárolni?"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="5. Hvernig geyma á X"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="5. Conas X a stóráil"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="5. Come conservare X"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="5. Kā uzglabāt X"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="5. Kaip laikyti X"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="5. Kif taħżen X"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="5. Hvordan du oppbevarer X"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="5. Jak przechowywać [lek] X"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="5. Como conservar X"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="5. Cum se păstrează X"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="5. Ako uchovávať X"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="5. Shranjevanje zdravila X"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="5. Conservación de X"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="5. Hur X ska förvaras"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029914"/>
    <display value="6. Contents of the pack and other information"/>
    <designation>
      <language value="en"/>
      <value value="6. Contents of the pack and other information"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="6. Съдържание на опаковката и допълнителна информация"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="6. Sadržaj pakiranja i druge informacije"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="6. Obsah balení a další informace"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="6. Pakningsstørrelser og yderligere oplysninger"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="6. Inhoud van de verpakking en overige informatie"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="6. Pakendi sisu ja muu teave"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="6. Pakkauksen sisältö ja muuta tietoa"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="6. Contenu de l’emballage et autres informations"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="6. Inhalt der Packung und weitere Informationen"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="6. Περιεχόμενα της συσκευασίας και λοιπές πληροφορίες"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="6. A csomagolás tartalma és egyéb információk"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="6. Pakkningar og aðrar upplýsingar"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="6. Inneachar an phacáiste agus faisnéis eile"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="6. Contenuto della confezione e altre informazioni"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="6. Iepakojuma saturs un cita informācija"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="6. Pakuotės turinys ir kita informacija"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="6. Kontenut tal-pakkett u informazzjoni oħra"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="6. Innholdet i pakningen og ytterligere informasjon"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="6. Zawartość opakowania i inne informacje"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="6. Conteúdo da embalagem e outras informações"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="6. Conținutul ambalajului și alte informații"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="6. Obsah balenia a ďalšie informácie"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="6. Vsebina pakiranja in dodatne informacije"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="6. Contenido del envase e información adicional"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="6. Förpackningens innehåll och övriga upplysningar"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029915"/>
    <display value="What X contains"/>
    <designation>
      <language value="en"/>
      <value value="What X contains"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Какво съдържа X"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Što X sadrži"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Co [přípravek] X obsahuje"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="{X} indeholder:"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Welke stoffen zitten er in dit middel?"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Mida X sisaldab"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Mitä X sisältää"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Ce que contient X"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Was X enthält"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Τι περιέχει το Χ"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Mit tartalmaz a(z) X?"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="X inniheldur"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="A bhfuil in X"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Cosa contiene X"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Ko X satur"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="X sudėtis"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="X’fih X"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Sammensetning av X"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Co zawiera [lek] X"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Qual a composição de X"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Ce conține X"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Čo X obsahuje"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Kaj vsebuje zdravilo X"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Composición de X"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Innehållsdeklaration"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029916"/>
    <display value="What X looks like and contents of the pack"/>
    <designation>
      <language value="en"/>
      <value value="What X looks like and contents of the pack"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Как изглежда X и какво съдържа опаковката"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Kako X izgleda i sadržaj pakiranja"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Jak[přípravek] X vypadá a co obsahuje toto balení"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Udseende og pakningsstørrelser"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Hoe ziet X eruit en hoeveel zit er in een verpakking?"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Kuidas X välja näeb ja pakendi sisu"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Lääkevalmisteen kuvaus ja pakkauskoko (-koot)"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value
             value="Comment se présente X et contenu de l’emballage extérieur"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Wie X aussieht und Inhalt der Packung"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Εμφάνιση του Χ και περιεχόμενα της συσκευασίας"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Milyen a(z) X külleme és mit tartalmaz a csomagolás?"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Lýsing á útliti X og pakkningastærðir"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="An chuma atá ar X agus inneachar an phacáiste"/>
    </designation>
    <designation>
      <language value="it"/>
      <value
             value="Descrizione dell’aspetto di X e contenuto della confezione"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="X ārējais izskats un iepakojums"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="X išvaizda ir kiekis pakuotėje"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Kif jidher X u l-kontenut tal-pakkett"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Hvordan X ser ut og innholdet i pakningen"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Jak wygląda [lek] X i co zawiera opakowanie"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Qual o aspeto de X e conteúdo da embalagem"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Cum arată X și conținutul ambalajului"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Ako vyzerá X a obsah balenia"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Izgled zdravila X in vsebina pakiranja"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Aspecto del producto y contenido del envase"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Läkemedlets utseende och förpackningsstorlekar"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029917"/>
    <display value="Marketing Authorisation Holder and Manufacturer"/>
    <designation>
      <language value="en"/>
      <value value="Marketing Authorisation Holder and Manufacturer"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Притежател на разрешението за употреба и производител"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value
             value="Nositelj odobrenja za stavljanje lijeka u promet i proizvođač"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Držitel rozhodnutí o registraci a výrobce"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Indehaver af markedsføringstilladelsen og fremstiller"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value
             value="Houder van de vergunning voor het in de handel brengen en fabrikant"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Müügiloa hoidja ja tootja"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Myyntiluvan haltija ja valmistaja"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value
             value="Titulaire de l’Autorisation de mise sur le marché et fabricant"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Pharmazeutischer Unternehmer und Hersteller"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Κάτοχος Άδειας Κυκλοφορίας και Παρασκευαστής"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="A forgalomba hozatali engedély jogosultja és a gyártó"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Markaðsleyfishafi og framleiðandi"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Sealbhóir an Údaraithe Margaíochta agus an Monaróir"/>
    </designation>
    <designation>
      <language value="it"/>
      <value
             value="Titolare dell’autorizzazione all’immissione in commercio e produttore"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Reģistrācijas apliecības īpašnieks un ražotājs"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Registruotojas ir gamintojas"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value
             value="Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Innehaver av markedsføringstillatelsen og tilvirker"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Podmiot odpowiedzialny i wytwórca"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value
             value="Titular da Autorização de Introdução no Mercado e Fabricante"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value
             value="Deținătorul autorizației de punere pe piață și fabricantul"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Držiteľ rozhodnutia o registrácii a výrobca"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value
             value="Imetnik dovoljenja za promet z zdravilom in proizvajalec"/>
    </designation>
    <designation>
      <language value="es"/>
      <value
             value="Titular de la autorización de comercialización y responsable de la fabricación"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value
             value="Innehavare av godkännande för försäljning och tillverkare"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029918"/>
    <display
             value="This medicine is authorised in the Member States of the European Economic Area [and in the United Kingdom (Northern Ireland)] under the following names:"/>
    <designation>
      <language value="en"/>
      <value
             value="This medicine is authorised in the Member States of the European Economic Area [and in the United Kingdom (Northern Ireland)] under the following names:"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value
             value="Това лекарство е разрешено за употреба в държавите ― членки на Европейското икономическо пространство, [и в Обединеното кралство (Северна Ирландия)] под следните имена:"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value
             value="Ovaj lijek odobren je u državama članicama Europskog gospodarskog prostora i Ujedinjenoj Kraljevini (Sjevernoj Irskoj) pod sljedećim nazivima:"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value
             value="Tento léčivý přípravek je v členských státech Evropského hospodářského prostoru [a ve Spojeném království (Severním Irsku)] registrován pod těmito názvy:"/>
    </designation>
    <designation>
      <language value="da"/>
      <value
             value="Dette lægemiddel er godkendt i medlemslandene i Det Europæiske Økonomiske Samarbejdsområde [og i Det Forenede Kongerige (Nordirland)] under følgende navne:"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value
             value="Dit medicijn is geregistreerd in lidstaten van de Europese Economische Ruimte [en in het Verenigd Koninkrijk (Noord-Ierland)] onder de volgende namen:"/>
    </designation>
    <designation>
      <language value="et"/>
      <value
             value="See ravim on saanud müügiloa Euroopa Majanduspiirkonna liikmesriikides [ja Ühendkuningriigis (Põhja-Iirimaal)] järgmiste nimetustega:"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value
             value="Tällä lääkkeellä on myyntilupa Euroopan talousalueeseen kuuluvissa jäsenvaltioissa [ja Yhdistyneessä kuningaskunnassa (Pohjois-Irlannissa)] seuraavilla kauppanimillä:"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value
             value="Ce médicament est autorisé dans les Etats membres de l'Espace Economique Européen [et au Royaume-Uni (Irlande du Nord)] sous les noms suivants :"/>
    </designation>
    <designation>
      <language value="de"/>
      <value
             value="Dieses Arzneimittel ist in den Mitgliedsstaaten des Europäischen Wirtschaftsraumes (EWR) [und im Vereinigten Königreich (Nordirland)] unter den folgenden Bezeichnungen zugelassen:"/>
    </designation>
    <designation>
      <language value="el"/>
      <value
             value="Αυτό το φάρμακο έχει εγκριθεί στα Κράτη Μέλη του Ευρωπαϊκού Οικονομικού Χώρου (ΕΟΧ) [και στο Ηνωμένο Βασίλειο (Βόρεια Ιρλανδία)] με τις ακόλουθες ονομασίες:"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value
             value="Ezt a gyógyszert az Európai Gazdasági Térség tagállamaiban [és az Egyesült Királyságban (Észak-Írországban)] az alábbi neveken engedélyezték:"/>
    </designation>
    <designation>
      <language value="is"/>
      <value
             value="Þetta lyf hefur markaðsleyfi í löndum Evrópska efnahagssvæðisins [og í Bretlandi (Norður-Írland)] undir eftirfarandi heitum:"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value
             value="Tá an cógas seo údaraithe i mBallstáit an Limistéir Eorpaigh Eacnamaíoch [agus sa Ríocht Aontaithe (Tuaisceart Éireann)] faoi na hainmneacha seo a leanas:"/>
    </designation>
    <designation>
      <language value="it"/>
      <value
             value="Questo medicinale è autorizzato negli Stati Membri dello Spazio economico europeo [e nel Regno Unito (Irlanda del Nord)] con le seguenti denominazioni:"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value
             value="Šīs zāles Eiropas Ekonomikas zonas (EEZ) dalībvalstīs [un Apvienotajā Karalistē (Ziemļīrijā)] ir reģistrētas ar šādiem nosaukumiem:"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value
             value="Šis vaistas Europos ekonominės erdvės valstybėse narėse [ir Jungtinėje Karalystėje (Šiaurės Airijoje)] registruotas tokiais pavadinimais:"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value
             value="Dan il-prodott mediċinali huwa awtorizzat fl-Istati Membri taż-Żona Ekonomika Ewropea u fir-Renju Unit tal-Irlanda (l-Irlanda ta’ Fuq) b'dawn l-ismijiet li ġejjin:"/>
    </designation>
    <designation>
      <language value="no"/>
      <value
             value="Dette legemidlet er godkjent i medlemsstatene i Det europeiske økonomiske samarbeidsområde [og i Storbritannia (Nord-Irland)] med følgende navn:"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value
             value="Ten lek jest dopuszczony do obrotu w krajach członkowskich Europejskiego Obszaru Gospodarczego [i w Zjednoczonym Królestwie (Irlandii Północnej)] pod następującymi nazwami:"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value
             value="Este medicamento encontra-se autorizado nos Estados Membros do Espaço Económico Europeu (EEE) [e no Reino Unido (Irlanda do Norte)] com os seguintes nomes:"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value
             value="Acest medicament este autorizat în statele membre ale Spaţiului Economic European și în Regatul Unit (Irlanda de Nord) sub următoarele denumiri comerciale:"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value
             value="Liek je schválený v členských štátoch Európskeho hospodárskeho priestoru [a v Spojenom kráľovstve (Severnom Írsku)] pod nasledovnými názvami:"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value
             value="Zdravilo je v državah članicah Evropskega gospodarskega prostora in Združenem kraljestvu (Severnem Irskem) pridobilo dovoljenje za promet z naslednjimi imeni:"/>
    </designation>
    <designation>
      <language value="es"/>
      <value
             value="Este medicamento está autorizado en los estados miembros del Espacio Económico Europeo [y en el Reino Unido (Irlande del Norte)] con los siguientes nombres:"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value
             value="Detta läkemedel är godkänt inom Europeiska ekonomiska samarbetsområdet [och i Förenade kungariket (Nordirland)] under namnen:"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029919"/>
    <display
             value="This leaflet was last revised in [{MM/YYYY}][{month YYYY}]."/>
    <designation>
      <language value="en"/>
      <value
             value="This leaflet was last revised in [{MM/YYYY}][{month YYYY}]."/>
    </designation>
    <designation>
      <language value="bg"/>
      <value
             value="Дата на последно преразглеждане на листовката [{ММ /ГГГГ}] [{месец ГГГГ}]."/>
    </designation>
    <designation>
      <language value="hr"/>
      <value
             value="Ova uputa je zadnji puta revidirana u [{MM/GGGG}] [{mjesec GGGG}]."/>
    </designation>
    <designation>
      <language value="cs"/>
      <value
             value="Tato příbalová informace byla naposledy revidována [{DD. MM. RRRR}] [{MM/RRRR}] [{měsíc RRRR}]."/>
    </designation>
    <designation>
      <language value="da"/>
      <value
             value="Denne indlægsseddel blev senest ændret [{MM/ÅÅÅÅ}] [{måned ÅÅÅÅ}.]"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value
             value="Deze bijsluiter is voor het laatst goedgekeurd in [{MM/JJJJ}] [{maand JJJJ}]."/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Infoleht on viimati uuendatud [KK.AAAA] [kuu AAAA]."/>
    </designation>
    <designation>
      <language value="fi"/>
      <value
             value="Tämä pakkausseloste on tarkistettu viimeksi [{KK.VVVV}] [{kuukausi VVVV}]."/>
    </designation>
    <designation>
      <language value="fr"/>
      <value
             value="La dernière date à laquelle cette notice a été révisée est [{MM/AAAA}] [{mois AAAA}."/>
    </designation>
    <designation>
      <language value="de"/>
      <value
             value="Diese Packungsbeilage wurde zuletzt überarbeitet im [{MM.JJJJ}] [{Monat JJJJ}]."/>
    </designation>
    <designation>
      <language value="el"/>
      <value
             value="Το παρόν φύλλο οδηγιών χρήσης αναθεωρήθηκε για τελευταία φορά στις [{ΜΜ/ΕΕΕΕ}] [{μήνας ΕΕΕΕ}.]"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value
             value="A betegtájékoztató legutóbbi felülvizsgálatának dátuma:[{ÉÉÉÉ. hónap}]"/>
    </designation>
    <designation>
      <language value="is"/>
      <value
             value="Þessi fylgiseðill var síðast uppfærður [{MM/ÁÁÁÁ}] [í {mánuður ÁÁÁÁ}]."/>
    </designation>
    <designation>
      <language value="ga"/>
      <value
             value="Rinneadh athbhreithniú den uair dheireanach ar an mbileog seo i [{MM/BBBB}][mí YYYY}]."/>
    </designation>
    <designation>
      <language value="it"/>
      <value
             value="Questo foglio illustrativo è stato aggiornato [{MM/AAAA}][{mese AAAA}]."/>
    </designation>
    <designation>
      <language value="lv"/>
      <value
             value="Šī lietošanas instrukcija pēdējo reizi pārskatīta [{MM/GGGG}] [GGGG. gada mēnesis}]"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value
             value="Šis pakuotės lapelis paskutinį kartą peržiūrėtas [{MMMM m. {mėnesio} mėn.}.]."/>
    </designation>
    <designation>
      <language value="mt"/>
      <value
             value="Dan il-fuljett kien rivedut l-aħħar f’ [{XX/SSSS} ][{xahar SSSS} ]."/>
    </designation>
    <designation>
      <language value="no"/>
      <value
             value="Dette pakningsvedlegget ble sist oppdatert [{MM/ÅÅÅÅ}] [{måned ÅÅÅÅ}]."/>
    </designation>
    <designation>
      <language value="pl"/>
      <value
             value="Data ostatniej aktualizacji ulotki: [{MM/RRRR}][{miesiąc RRRR}]."/>
    </designation>
    <designation>
      <language value="pt"/>
      <value
             value="Este folheto foi revisto pela última vez em [{MM/AAAA}][{mês de AAAA}.]"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value
             value="Acest prospect a fost revizuit în [{LL/AAAA}][{luna AAAA}]."/>
    </designation>
    <designation>
      <language value="sk"/>
      <value
             value="Táto písomná informácia bola naposledy aktualizovaná v [{MM/RRRR}] [{mesiac RRRR}]."/>
    </designation>
    <designation>
      <language value="sl"/>
      <value
             value="Navodilo je bilo nazadnje revidirano dne [{MM/LLLL}] [{mesec LLLL}]"/>
    </designation>
    <designation>
      <language value="es"/>
      <value
             value="Fecha de la última revisión de este prospecto: [{MM/AAAA}][{mes AAAA}]."/>
    </designation>
    <designation>
      <language value="sv"/>
      <value
             value="Denna bipacksedel ändrades senast [{MM/ÅÅÅÅ}][{månad ÅÅÅÅ}]"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029920"/>
    <display value="Other sources of information"/>
    <designation>
      <language value="en"/>
      <value value="Other sources of information"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="Други източници на информация"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Ostali izvori informacija"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value value="Další zdroje informací"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Andre informationskilder"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Andere informatiebronnen"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Muud teabeallikad"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Muut tiedonlähteet"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value value="Autres sources d’informations"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Weitere Informationsquellen"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="Άλλες πηγές πληροφοριών"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value value="Egyéb információforrások"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Upplýsingar sem hægt er að nálgast annars staðar"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Foinsí eile faisnéise"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Altre fonti d’informazioni"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Citi informācijas avoti"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Kiti informacijos šaltiniai"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Sorsi oħra ta’ informazzjoni"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Andre informasjonskilder"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Inne źródła informacji"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Outras fontes de informação"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Alte surse de informații"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Ďalšie zdroje informácií"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Drugi viri informacij"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Otras fuentes de información"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Övriga informationskällor"/>
    </designation>
  </concept>
  <concept>
    <code value="200000029921"/>
    <display
             value="The following information is intended for healthcare professionals only:"/>
    <designation>
      <language value="en"/>
      <value
             value="The following information is intended for healthcare professionals only:"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value
             value="Посочената по-долу информация е предназначена само за медицински специалисти:"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value
             value="Sljedeće informacije namijenjene su samo zdravstvenim radnicima:"/>
    </designation>
    <designation>
      <language value="cs"/>
      <value
             value="Následující informace jsou určeny pouze pro zdravotnické pracovníky:"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Nedenstående oplysninger er kun til sundhedspersoner:"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value
             value="De volgende informatie is alleen bestemd voor beroepsbeoefenaren in de gezondheidszorg:"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Järgmine teave on ainult tervishoiutöötajatele:"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value
             value="Seuraavat tiedot on tarkoitettu vain terveydenhuollon ammattilaisille:"/>
    </designation>
    <designation>
      <language value="fr"/>
      <value
             value="Les informations suivantes sont destinées exclusivement aux professionnels de la santé:"/>
    </designation>
    <designation>
      <language value="de"/>
      <value
             value="Die folgenden Informationen sind für medizinisches Fachpersonal bestimmt:"/>
    </designation>
    <designation>
      <language value="el"/>
      <value
             value="Οι πληροφορίες που ακολουθούν απευθύνονται μόνο σε επαγγελματίες υγείας:"/>
    </designation>
    <designation>
      <language value="hu"/>
      <value
             value="Az alábbi információk kizárólag egészségügyi szakembereknek szólnak:"/>
    </designation>
    <designation>
      <language value="is"/>
      <value
             value="Eftirfarandi upplýsingar eru einungis ætlaðar heilbrigðisstarfsmönnum:"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value
             value="Níl an fhaisnéis seo a leanas ach do ghairmithe cúraim sláinte:"/>
    </designation>
    <designation>
      <language value="it"/>
      <value
             value="Le informazioni seguenti sono destinate esclusivamente agli operatori sanitari:"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value
             value="Tālāk sniegtā informācija paredzēta tikai veselības aprūpes speciālistiem."/>
    </designation>
    <designation>
      <language value="lt"/>
      <value
             value="Toliau pateikta informacija skirta tik sveikatos priežiūros specialistams."/>
    </designation>
    <designation>
      <language value="mt"/>
      <value
             value="It-tagħrif li jmiss qed jingħata biss għall-professjonisti tal-kura tas-saħħa biss:"/>
    </designation>
    <designation>
      <language value="no"/>
      <value
             value="Påfølgende informasjon er bare beregnet på helsepersonell:"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value
             value="Informacje przeznaczone wyłącznie dla fachowego personelu medycznego:"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value
             value="A informação que se segue destina-se apenas aos profissionais de saúde:"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value
             value="Următoarele informații sunt destinate numai profesioniștilor din domeniul sănătății:"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value
             value="Nasledujúca informácia je určená len pre zdravotníckych pracovníkov:"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value
             value="Naslednje informacije so namenjene samo zdravstvenemu osebju:"/>
    </designation>
    <designation>
      <language value="es"/>
      <value
             value="Esta información está destinada únicamente a profesionales sanitarios:"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value
             value="Följande uppgifter är endast avsedda för hälso- och sjukvårdspersonal:"/>
    </designation>
  </concept>
  <concept>
    <code value="200000044346"/>
    <display value="Level=H3 PL custom subsection"/>
    <designation>
      <language value="en"/>
      <value value="Level=H3 PL custom subsection"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="ниво=H3 PL персонализиран подраздел"/>
    </designation>
    <designation>
      <language value="hr"/>
      <value value="Razina=H3 PL prilagođeni pododjeljak"/>
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    <designation>
      <language value="cs"/>
      <value value="Uroveň=H3 PL vlastní podsekce"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Niveau=H3 PL brugerdefineret underafsnit"/>
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    <designation>
      <language value="nl"/>
      <value value="Niveau=H3 PL aangepaste subsectie"/>
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    <designation>
      <language value="et"/>
      <value value="Tase=H3 PL kohandatud alajaotis"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Taso=H3 PL mukautettu alaosio"/>
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    <designation>
      <language value="fr"/>
      <value value="Niveau=H3 PL sous-section personnalisée"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Ebene=H3 PL benutzerdefinierter unterabschnitt"/>
    </designation>
    <designation>
      <language value="el"/>
      <value value="επίπεδο=H3 PL προσαρμοσμένη υποενότητα"/>
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    <designation>
      <language value="hu"/>
      <value value="Szint=H3 PL egyéni alfejezet"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Stig=H3 PL sérsniðin undirkafli"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Leibhéal=H3 PL fo-alt saincheaptha"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Livello=H3 PL sottosezione personalizzata"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Līmenis=H3 PL pielāgota apakšnodaļa"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Lygis=H3 PL pritaikyta poskyris"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Livell=H3 PL sottotaqsima personalizzata"/>
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    <designation>
      <language value="no"/>
      <value value="Nivå=H3 PL tilpasset underavsnitt"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Poziom=H3 PL niestandardowa podsekcja"/>
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    <designation>
      <language value="pt"/>
      <value value="Nível=H3 PL subseção personalizada"/>
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    <designation>
      <language value="ro"/>
      <value value="Nivel=H3 PL subsecțiune personalizată"/>
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    <designation>
      <language value="sk"/>
      <value value="Úroveň=H3 PL vlastná podsekcia"/>
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    <designation>
      <language value="sl"/>
      <value value="Raven=H3 PL prilagojeni pododdelek"/>
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    <designation>
      <language value="es"/>
      <value value="Nivel=H3 PL subsección personalizada"/>
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    <designation>
      <language value="sv"/>
      <value value="Nivå=H3 PL anpassad underavdelning"/>
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  <concept>
    <code value="200000044333"/>
    <display value="Level=H4 SmPC custom subsection"/>
    <designation>
      <language value="en"/>
      <value value="Level=H4 SmPC custom subsection"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="ниво=H4 SmPC персонализиран подраздел"/>
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    <designation>
      <language value="hr"/>
      <value value="Razina=H4 SmPC prilagođeni pododjeljak"/>
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    <designation>
      <language value="cs"/>
      <value value="Uroveň=H4 SmPC vlastní podsekce"/>
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    <designation>
      <language value="da"/>
      <value value="Niveau=H4 SmPC brugerdefineret underafsnit"/>
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    <designation>
      <language value="nl"/>
      <value value="Niveau=H4 SmPC aangepaste subsectie"/>
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    <designation>
      <language value="et"/>
      <value value="Tase=H4 SmPC kohandatud alajaotis"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Taso=H4 SmPC mukautettu alaosio"/>
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    <designation>
      <language value="fr"/>
      <value value="Niveau=H4 SmPC sous-section personnalisée"/>
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    <designation>
      <language value="de"/>
      <value value="Ebene=H4 SmPC benutzerdefinierter unterabschnitt"/>
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    <designation>
      <language value="el"/>
      <value value="επίπεδο=H4 SmPC προσαρμοσμένη υποενότητα"/>
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    <designation>
      <language value="hu"/>
      <value value="Szint=H4 SmPC egyéni alfejezet"/>
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    <designation>
      <language value="is"/>
      <value value="Stig=H4 SmPC sérsniðin undirkafli"/>
    </designation>
    <designation>
      <language value="ga"/>
      <value value="Leibhéal=H4 SmPC fo-alt saincheaptha"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Livello=H4 SmPC sottosezione personalizzata"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Līmenis=H4 SmPC pielāgota apakšnodaļa"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Lygis=H4 SmPC pritaikyta poskyris"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Livell=H4 SmPC sottotaqsima personalizzata"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Nivå=H4 SmPC tilpasset underavsnitt"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Poziom=H4 SmPC niestandardowa podsekcja"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Nível=H4 SmPC subseção personalizada"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Nivel=H4 SmPC subsecțiune personalizată"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Úroveň=H4 SmPC vlastná podsekcia"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Raven=H4 SmPC prilagojeni pododdelek"/>
    </designation>
    <designation>
      <language value="es"/>
      <value value="Nivel=H4 SmPC subsección personalizada"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Nivå=H4 SmPC PL anpassad underavdelning"/>
    </designation>
  </concept>
  <concept>
    <code value="200000044347"/>
    <display value="Level=H5 SmPC custom subsection"/>
    <designation>
      <language value="en"/>
      <value value="Level=H5 SmPC custom subsection"/>
    </designation>
    <designation>
      <language value="bg"/>
      <value value="ниво=H5 SmPC персонализиран подраздел"/>
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    <designation>
      <language value="hr"/>
      <value value="Razina=H5 SmPC prilagođeni pododjeljak"/>
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    <designation>
      <language value="cs"/>
      <value value="Uroveň=H5 SmPC vlastní podsekce"/>
    </designation>
    <designation>
      <language value="da"/>
      <value value="Niveau=H5 SmPC brugerdefineret underafsnit"/>
    </designation>
    <designation>
      <language value="nl"/>
      <value value="Niveau=H5 SmPC aangepaste subsectie"/>
    </designation>
    <designation>
      <language value="et"/>
      <value value="Tase=H5 SmPC kohandatud alajaotis"/>
    </designation>
    <designation>
      <language value="fi"/>
      <value value="Taso=H5 SmPC mukautettu alaosio"/>
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    <designation>
      <language value="fr"/>
      <value value="Niveau=H5 SmPC sous-section personnalisée"/>
    </designation>
    <designation>
      <language value="de"/>
      <value value="Ebene=H5 SmPC benutzerdefinierter unterabschnitt"/>
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    <designation>
      <language value="el"/>
      <value value="επίπεδο=H5 SmPC προσαρμοσμένη υποενότητα"/>
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    <designation>
      <language value="hu"/>
      <value value="Szint=H5 SmPC egyéni alfejezet"/>
    </designation>
    <designation>
      <language value="is"/>
      <value value="Stig=H5 SmPC sérsniðin undirkafli"/>
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    <designation>
      <language value="ga"/>
      <value value="Leibhéal=H5 SmPC fo-alt saincheaptha"/>
    </designation>
    <designation>
      <language value="it"/>
      <value value="Livello=H5 SmPC sottosezione personalizzata"/>
    </designation>
    <designation>
      <language value="lv"/>
      <value value="Līmenis=H5 SmPC pielāgota apakšnodaļa"/>
    </designation>
    <designation>
      <language value="lt"/>
      <value value="Lygis=H5 SmPC pritaikyta poskyris"/>
    </designation>
    <designation>
      <language value="mt"/>
      <value value="Livell=H5 SmPC sottotaqsima personalizzata"/>
    </designation>
    <designation>
      <language value="no"/>
      <value value="Nivå=H5 SmPC tilpasset underavsnitt"/>
    </designation>
    <designation>
      <language value="pl"/>
      <value value="Poziom=H5 SmPC niestandardowa podsekcja"/>
    </designation>
    <designation>
      <language value="pt"/>
      <value value="Nível=H5 SmPC subseção personalizada"/>
    </designation>
    <designation>
      <language value="ro"/>
      <value value="Nivel=H5 SmPC subsecțiune personalizată"/>
    </designation>
    <designation>
      <language value="sk"/>
      <value value="Úroveň=H5 SmPC vlastná podsekcia"/>
    </designation>
    <designation>
      <language value="sl"/>
      <value value="Raven=H5 SmPC prilagojeni pododdelek"/>
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    <designation>
      <language value="es"/>
      <value value="Nivel=H5 SmPC subsección personalizada"/>
    </designation>
    <designation>
      <language value="sv"/>
      <value value="Nivå=H5 SmPC PL anpassad underavdelning"/>
    </designation>
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</CodeSystem>