European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide
1.0.0 - ci-build
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
| Active as of 2025-04-02 |
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: ValueSet EUepicapqrdcodesVs</b></p><a name=\"EUepicapqrdcodesVs\"> </a><a name=\"hcEUepicapqrdcodesVs\"> </a><a name=\"EUepicapqrdcodesVs-en-US\"> </a><ul><li>Include these codes as defined in <a href=\"CodeSystem-200000029659.html\"><code>http://ema.europa.eu/fhir/CodeSystem/200000029659</code></a><table class=\"none\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-000000000000\">000000000000</a></td><td style=\"color: #cccccc\">Code for custom sub-sections (reserved)</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029791\">200000029791</a></td><td style=\"color: #cccccc\">SUMMARY OF PRODUCT CHARACTERISTICS</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029792\">200000029792</a></td><td style=\"color: #cccccc\">1. NAME OF THE MEDICINAL PRODUCT</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029793\">200000029793</a></td><td style=\"color: #cccccc\">2. QUALITATIVE AND QUANTITATIVE COMPOSITION</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029794\">200000029794</a></td><td style=\"color: #cccccc\">2.1 General description</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029795\">200000029795</a></td><td style=\"color: #cccccc\">2.2 Qualitative and quantitative composition</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029796\">200000029796</a></td><td style=\"color: #cccccc\">Excipient(s) with known effect</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029797\">200000029797</a></td><td style=\"color: #cccccc\">3. PHARMACEUTICAL FORM</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029798\">200000029798</a></td><td style=\"color: #cccccc\">4. CLINICAL PARTICULARS</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029799\">200000029799</a></td><td style=\"color: #cccccc\">4.1 Therapeutic indications</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029800\">200000029800</a></td><td style=\"color: #cccccc\">4.2 Posology and method of administration</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029801\">200000029801</a></td><td style=\"color: #cccccc\">Posology</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029802\">200000029802</a></td><td style=\"color: #cccccc\">Paediatric population</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029803\">200000029803</a></td><td style=\"color: #cccccc\">Method of administration</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029804\">200000029804</a></td><td style=\"color: #cccccc\">Precautions to be taken before handling or administering the medicinal product</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029805\">200000029805</a></td><td style=\"color: #cccccc\">4.3 Contraindications</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029806\">200000029806</a></td><td style=\"color: #cccccc\">4.4 Special warnings and precautions for use</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029807\">200000029807</a></td><td style=\"color: #cccccc\">Traceability</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029808\">200000029808</a></td><td style=\"color: #cccccc\">Paediatric population</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029809\">200000029809</a></td><td style=\"color: #cccccc\">4.5 Interaction with other medicinal products and other forms of interaction</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029810\">200000029810</a></td><td style=\"color: #cccccc\">Paediatric population</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029811\">200000029811</a></td><td style=\"color: #cccccc\">4.6 Fertility, pregnancy and lactation</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029812\">200000029812</a></td><td style=\"color: #cccccc\">Pregnancy</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029813\">200000029813</a></td><td style=\"color: #cccccc\">Breast-feeding</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029814\">200000029814</a></td><td style=\"color: #cccccc\">Fertility</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029815\">200000029815</a></td><td style=\"color: #cccccc\">4.7 Effects on ability to drive and use machines</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029816\">200000029816</a></td><td style=\"color: #cccccc\">4.8 Undesirable effects</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029817\">200000029817</a></td><td style=\"color: #cccccc\">Paediatric population</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029818\">200000029818</a></td><td style=\"color: #cccccc\">Reporting of suspected adverse reactions</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029819\">200000029819</a></td><td style=\"color: #cccccc\">4.9 Overdose</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029820\">200000029820</a></td><td style=\"color: #cccccc\">Paediatric population</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029821\">200000029821</a></td><td style=\"color: #cccccc\">5. PHARMACOLOGICAL PROPERTIES</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029822\">200000029822</a></td><td style=\"color: #cccccc\">5.1 Pharmacodynamic properties</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029823\">200000029823</a></td><td style=\"color: #cccccc\">Mechanism of action</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029824\">200000029824</a></td><td style=\"color: #cccccc\">Pharmacodynamic effects</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029825\">200000029825</a></td><td style=\"color: #cccccc\">Clinical efficacy and safety</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029826\">200000029826</a></td><td style=\"color: #cccccc\">Paediatric population</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029827\">200000029827</a></td><td style=\"color: #cccccc\">5.2 Pharmacokinetic properties</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029828\">200000029828</a></td><td style=\"color: #cccccc\">Absorption</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029829\">200000029829</a></td><td style=\"color: #cccccc\">Distribution</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029830\">200000029830</a></td><td style=\"color: #cccccc\">Biotransformation</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029831\">200000029831</a></td><td style=\"color: #cccccc\">Elimination</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029832\">200000029832</a></td><td style=\"color: #cccccc\">Linearity/non-linearity</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029833\">200000029833</a></td><td style=\"color: #cccccc\">Pharmacokinetic/pharmacodynamic relationship(s)</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029834\">200000029834</a></td><td style=\"color: #cccccc\">5.3 Preclinical safety data</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029835\">200000029835</a></td><td style=\"color: #cccccc\">Environmental risk assessment (ERA)</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029836\">200000029836</a></td><td style=\"color: #cccccc\">6. PHARMACEUTICAL PARTICULARS</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029837\">200000029837</a></td><td style=\"color: #cccccc\">6.1 List of excipients</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029838\">200000029838</a></td><td style=\"color: #cccccc\">6.2 Incompatibilities</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029839\">200000029839</a></td><td style=\"color: #cccccc\">6.3 Shelf life</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029840\">200000029840</a></td><td style=\"color: #cccccc\">6.4 Special precautions for storage</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029841\">200000029841</a></td><td style=\"color: #cccccc\">6.5 Nature and contents of container [and special equipment for use, administration or implantation]</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029842\">200000029842</a></td><td style=\"color: #cccccc\">6.6 Special precautions for disposal [and other handling]</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029843\">200000029843</a></td><td style=\"color: #cccccc\">Use in the paediatric population</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029844\">200000029844</a></td><td style=\"color: #cccccc\">7. MARKETING AUTHORISATION HOLDER</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029845\">200000029845</a></td><td style=\"color: #cccccc\">8. MARKETING AUTHORISATION NUMBER(S)</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029846\">200000029846</a></td><td style=\"color: #cccccc\">9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029847\">200000029847</a></td><td style=\"color: #cccccc\">10. DATE OF REVISION OF THE TEXT</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029848\">200000029848</a></td><td style=\"color: #cccccc\">11. DOSIMETRY</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029849\">200000029849</a></td><td style=\"color: #cccccc\">12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029850\">200000029850</a></td><td style=\"color: #cccccc\">ANNEX II</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029851\">200000029851</a></td><td style=\"color: #cccccc\">A. [MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND] MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029852\">200000029852</a></td><td style=\"color: #cccccc\">B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029853\">200000029853</a></td><td style=\"color: #cccccc\">Official batch release</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029854\">200000029854</a></td><td style=\"color: #cccccc\">C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029855\">200000029855</a></td><td style=\"color: #cccccc\">Periodic safety update reports (PSURs)</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029856\">200000029856</a></td><td style=\"color: #cccccc\">D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029857\">200000029857</a></td><td style=\"color: #cccccc\">Risk management plan (RMP)</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029858\">200000029858</a></td><td style=\"color: #cccccc\">Additional risk minimisation measures</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029859\">200000029859</a></td><td style=\"color: #cccccc\">Obligation to conduct post-authorisation measures</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029860\">200000029860</a></td><td style=\"color: #cccccc\">E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR [THE CONDITIONAL MARKETING AUTHORISATION] [THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029861\">200000029861</a></td><td style=\"color: #cccccc\">LABELLING</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029862\">200000029862</a></td><td style=\"color: #cccccc\">PARTICULARS TO APPEAR ON [THE OUTER PACKAGING] [AND] [THE IMMEDIATE PACKAGING] {NATURE/TYPE}</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029863\">200000029863</a></td><td style=\"color: #cccccc\">1. NAME OF THE MEDICINAL PRODUCT</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029864\">200000029864</a></td><td style=\"color: #cccccc\">2. STATEMENT OF ACTIVE SUBSTANCE(S)</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029865\">200000029865</a></td><td style=\"color: #cccccc\">3. LIST OF EXCIPIENTS</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029866\">200000029866</a></td><td style=\"color: #cccccc\">4. PHARMACEUTICAL FORM AND CONTENTS</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029867\">200000029867</a></td><td style=\"color: #cccccc\">5. METHOD AND ROUTE(S) OF ADMINISTRATION</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029868\">200000029868</a></td><td style=\"color: #cccccc\">6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029869\">200000029869</a></td><td style=\"color: #cccccc\">7. OTHER SPECIAL WARNING(S), IF NECESSARY</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029870\">200000029870</a></td><td style=\"color: #cccccc\">8. EXPIRY DATE</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029871\">200000029871</a></td><td style=\"color: #cccccc\">9. SPECIAL STORAGE CONDITIONS</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029872\">200000029872</a></td><td style=\"color: #cccccc\">10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029873\">200000029873</a></td><td style=\"color: #cccccc\">11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029874\">200000029874</a></td><td style=\"color: #cccccc\">12. MARKETING AUTHORISATION NUMBER(S)</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029875\">200000029875</a></td><td style=\"color: #cccccc\">13. BATCH NUMBER[, DONATION AND PRODUCT CODES]</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029876\">200000029876</a></td><td style=\"color: #cccccc\">14. GENERAL CLASSIFICATION FOR SUPPLY</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029877\">200000029877</a></td><td style=\"color: #cccccc\">15. INSTRUCTIONS ON USE</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029878\">200000029878</a></td><td style=\"color: #cccccc\">16. INFORMATION IN BRAILLE</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029879\">200000029879</a></td><td style=\"color: #cccccc\">17. UNIQUE IDENTIFIER - 2D BARCODE</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029880\">200000029880</a></td><td style=\"color: #cccccc\">18. UNIQUE IDENTIFIER - HUMAN READABLE DATA</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029881\">200000029881</a></td><td style=\"color: #cccccc\">MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {NATURE/TYPE}</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029882\">200000029882</a></td><td style=\"color: #cccccc\">1. NAME OF THE MEDICINAL PRODUCT</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029883\">200000029883</a></td><td style=\"color: #cccccc\">2. NAME OF THE MARKETING AUTHORISATION HOLDER</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029884\">200000029884</a></td><td style=\"color: #cccccc\">3. EXPIRY DATE</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029885\">200000029885</a></td><td style=\"color: #cccccc\">4. BATCH NUMBER[, DONATION AND PRODUCT CODES]</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029886\">200000029886</a></td><td style=\"color: #cccccc\">5. OTHER</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029887\">200000029887</a></td><td style=\"color: #cccccc\">MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {NATURE/TYPE}</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029888\">200000029888</a></td><td style=\"color: #cccccc\">1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029889\">200000029889</a></td><td style=\"color: #cccccc\">2. METHOD OF ADMINISTRATION</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029890\">200000029890</a></td><td style=\"color: #cccccc\">3. EXPIRY DATE</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029891\">200000029891</a></td><td style=\"color: #cccccc\">4. BATCH NUMBER[, DONATION AND PRODUCT CODES]</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029892\">200000029892</a></td><td style=\"color: #cccccc\">5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029893\">200000029893</a></td><td style=\"color: #cccccc\">6. OTHER</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029894\">200000029894</a></td><td style=\"color: #cccccc\">PACKAGE LEAFLET</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029895\">200000029895</a></td><td style=\"color: #cccccc\">1. What X is and what it is used for</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029896\">200000029896</a></td><td style=\"color: #cccccc\">2. What you need to know before you [take] [use] X</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029897\">200000029897</a></td><td style=\"color: #cccccc\">Do not [take] [use] X</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029898\">200000029898</a></td><td style=\"color: #cccccc\">Warnings and precautions</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029899\">200000029899</a></td><td style=\"color: #cccccc\">Children [and adolescents]</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029900\">200000029900</a></td><td style=\"color: #cccccc\">Other medicines and X</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029901\">200000029901</a></td><td style=\"color: #cccccc\">X with [food] [and] [,] [drink] [and] [alcohol]</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029902\">200000029902</a></td><td style=\"color: #cccccc\">Pregnancy [and] [,] breast-feeding [and fertility]</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029903\">200000029903</a></td><td style=\"color: #cccccc\">Driving and using machines</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029904\">200000029904</a></td><td style=\"color: #cccccc\">X contains {name the excipient(s)}</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029905\">200000029905</a></td><td style=\"color: #cccccc\">3. How to [take] [use] X</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029906\">200000029906</a></td><td style=\"color: #cccccc\">Use in children [and adolescents]</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029907\">200000029907</a></td><td style=\"color: #cccccc\">If you [take] [use] more X than you should</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029908\">200000029908</a></td><td style=\"color: #cccccc\">If you forget to [take] [use] X</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029909\">200000029909</a></td><td style=\"color: #cccccc\">If you stop [taking] [using] X</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029910\">200000029910</a></td><td style=\"color: #cccccc\">4. Possible side effects</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029911\">200000029911</a></td><td style=\"color: #cccccc\">Additional side effects in children [and adolescents]</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029912\">200000029912</a></td><td style=\"color: #cccccc\">Reporting of side effects</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029913\">200000029913</a></td><td style=\"color: #cccccc\">5. How to store X</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029914\">200000029914</a></td><td style=\"color: #cccccc\">6. Contents of the pack and other information</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029915\">200000029915</a></td><td style=\"color: #cccccc\">What X contains</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029916\">200000029916</a></td><td style=\"color: #cccccc\">What X looks like and contents of the pack</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029917\">200000029917</a></td><td style=\"color: #cccccc\">Marketing Authorisation Holder and Manufacturer</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029919\">200000029919</a></td><td style=\"color: #cccccc\">This leaflet was last revised in [{MM/YYYY}][{month YYYY}].</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029920\">200000029920</a></td><td style=\"color: #cccccc\">Other sources of information</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029921\">200000029921</a></td><td style=\"color: #cccccc\">The following information is intended for healthcare professionals only:</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000044333\">200000044333</a></td><td style=\"color: #cccccc\">Level=H4 SmPC custom subsection</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000044346\">200000044346</a></td><td style=\"color: #cccccc\">Level=H3 PL custom subsection</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000044347\">200000044347</a></td><td style=\"color: #cccccc\">Level=H5 SmPC custom subsection</td></tr></table></li></ul></div>"
},
"url" : "http://ema.europa.eu/fhir/ValueSet/EUepicapqrdcodesVs",
"version" : "1.0.0",
"name" : "EUepicapqrdcodesVs",
"title" : "06 CAP Code Value Set",
"status" : "active",
"experimental" : false,
"date" : "2025-04-02T11:27:42+01:00",
"publisher" : "European Medicines Agency",
"contact" : [
{
"name" : "European Medicines Agency",
"telecom" : [
{
"system" : "url",
"value" : "https://ema.europa.eu/fhir"
}
]
},
{
"name" : "FHIR at EMA",
"telecom" : [
{
"system" : "url",
"value" : "http://ema.europa.eu/fhir"
}
]
}
],
"description" : "List of section codes allowed in Centrally Authorised Product (CAP) medicine documents, defined in EMA's Referentials Management Service.",
"compose" : {
"include" : [
{
"system" : "http://ema.europa.eu/fhir/CodeSystem/200000029659",
"concept" : [
{
"code" : "000000000000"
},
{
"code" : "200000029791"
},
{
"code" : "200000029792"
},
{
"code" : "200000029793"
},
{
"code" : "200000029794"
},
{
"code" : "200000029795"
},
{
"code" : "200000029796"
},
{
"code" : "200000029797"
},
{
"code" : "200000029798"
},
{
"code" : "200000029799"
},
{
"code" : "200000029800"
},
{
"code" : "200000029801"
},
{
"code" : "200000029802"
},
{
"code" : "200000029803"
},
{
"code" : "200000029804"
},
{
"code" : "200000029805"
},
{
"code" : "200000029806"
},
{
"code" : "200000029807"
},
{
"code" : "200000029808"
},
{
"code" : "200000029809"
},
{
"code" : "200000029810"
},
{
"code" : "200000029811"
},
{
"code" : "200000029812"
},
{
"code" : "200000029813"
},
{
"code" : "200000029814"
},
{
"code" : "200000029815"
},
{
"code" : "200000029816"
},
{
"code" : "200000029817"
},
{
"code" : "200000029818"
},
{
"code" : "200000029819"
},
{
"code" : "200000029820"
},
{
"code" : "200000029821"
},
{
"code" : "200000029822"
},
{
"code" : "200000029823"
},
{
"code" : "200000029824"
},
{
"code" : "200000029825"
},
{
"code" : "200000029826"
},
{
"code" : "200000029827"
},
{
"code" : "200000029828"
},
{
"code" : "200000029829"
},
{
"code" : "200000029830"
},
{
"code" : "200000029831"
},
{
"code" : "200000029832"
},
{
"code" : "200000029833"
},
{
"code" : "200000029834"
},
{
"code" : "200000029835"
},
{
"code" : "200000029836"
},
{
"code" : "200000029837"
},
{
"code" : "200000029838"
},
{
"code" : "200000029839"
},
{
"code" : "200000029840"
},
{
"code" : "200000029841"
},
{
"code" : "200000029842"
},
{
"code" : "200000029843"
},
{
"code" : "200000029844"
},
{
"code" : "200000029845"
},
{
"code" : "200000029846"
},
{
"code" : "200000029847"
},
{
"code" : "200000029848"
},
{
"code" : "200000029849"
},
{
"code" : "200000029850"
},
{
"code" : "200000029851"
},
{
"code" : "200000029852"
},
{
"code" : "200000029853"
},
{
"code" : "200000029854"
},
{
"code" : "200000029855"
},
{
"code" : "200000029856"
},
{
"code" : "200000029857"
},
{
"code" : "200000029858"
},
{
"code" : "200000029859"
},
{
"code" : "200000029860"
},
{
"code" : "200000029861"
},
{
"code" : "200000029862"
},
{
"code" : "200000029863"
},
{
"code" : "200000029864"
},
{
"code" : "200000029865"
},
{
"code" : "200000029866"
},
{
"code" : "200000029867"
},
{
"code" : "200000029868"
},
{
"code" : "200000029869"
},
{
"code" : "200000029870"
},
{
"code" : "200000029871"
},
{
"code" : "200000029872"
},
{
"code" : "200000029873"
},
{
"code" : "200000029874"
},
{
"code" : "200000029875"
},
{
"code" : "200000029876"
},
{
"code" : "200000029877"
},
{
"code" : "200000029878"
},
{
"code" : "200000029879"
},
{
"code" : "200000029880"
},
{
"code" : "200000029881"
},
{
"code" : "200000029882"
},
{
"code" : "200000029883"
},
{
"code" : "200000029884"
},
{
"code" : "200000029885"
},
{
"code" : "200000029886"
},
{
"code" : "200000029887"
},
{
"code" : "200000029888"
},
{
"code" : "200000029889"
},
{
"code" : "200000029890"
},
{
"code" : "200000029891"
},
{
"code" : "200000029892"
},
{
"code" : "200000029893"
},
{
"code" : "200000029894"
},
{
"code" : "200000029895"
},
{
"code" : "200000029896"
},
{
"code" : "200000029897"
},
{
"code" : "200000029898"
},
{
"code" : "200000029899"
},
{
"code" : "200000029900"
},
{
"code" : "200000029901"
},
{
"code" : "200000029902"
},
{
"code" : "200000029903"
},
{
"code" : "200000029904"
},
{
"code" : "200000029905"
},
{
"code" : "200000029906"
},
{
"code" : "200000029907"
},
{
"code" : "200000029908"
},
{
"code" : "200000029909"
},
{
"code" : "200000029910"
},
{
"code" : "200000029911"
},
{
"code" : "200000029912"
},
{
"code" : "200000029913"
},
{
"code" : "200000029914"
},
{
"code" : "200000029915"
},
{
"code" : "200000029916"
},
{
"code" : "200000029917"
},
{
"code" : "200000029919"
},
{
"code" : "200000029920"
},
{
"code" : "200000029921"
},
{
"code" : "200000044333"
},
{
"code" : "200000044346"
},
{
"code" : "200000044347"
}
]
}
]
}
}