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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<id value="100000155531"/>
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<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: CodeSystem 100000155531</b></p><a name="100000155531"> </a><a name="hc100000155531"> </a><a name="100000155531-en-US"> </a><p>This case-insensitive code system <code>http://ema.europa.eu/fhir/CodeSystem/100000155531</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">100000155532<a name="100000155531-100000155532"> </a></td><td>Summary of Product Characteristics</td></tr><tr><td style="white-space:nowrap">100000155533<a name="100000155531-100000155533"> </a></td><td>Annex II</td></tr><tr><td style="white-space:nowrap">100000155534<a name="100000155531-100000155534"> </a></td><td>Outer Packaging</td></tr><tr><td style="white-space:nowrap">100000155535<a name="100000155531-100000155535"> </a></td><td>Labelling</td></tr><tr><td style="white-space:nowrap">100000155537<a name="100000155531-100000155537"> </a></td><td>Other Product Information</td></tr><tr><td style="white-space:nowrap">100000155538<a name="100000155531-100000155538"> </a></td><td>Package Leaflet</td></tr><tr><td style="white-space:nowrap">100000155539<a name="100000155531-100000155539"> </a></td><td>Combined File of all Documents</td></tr><tr><td style="white-space:nowrap">100000155540<a name="100000155531-100000155540"> </a></td><td>Mock ups</td></tr><tr><td style="white-space:nowrap">100000155541<a name="100000155531-100000155541"> </a></td><td>Appendix V</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>100000155532</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>100000155533</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>100000155534</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>100000155535</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>100000155537</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>100000155538</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>100000155539</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>100000155540</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>100000155541</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></table></div>
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<url value="http://ema.europa.eu/fhir/CodeSystem/100000155531"/>
<version value="1.0.0"/>
<name value="EUepirmsdocumenttype"/>
<title value="01 Document Type Code System"/>
<status value="active"/>
<experimental value="false"/>
<date value="2025-04-02T11:27:42+01:00"/>
<publisher value="European Medicines Agency"/>
<contact>
<name value="European Medicines Agency"/>
<telecom>
<system value="url"/>
<value value="https://ema.europa.eu/fhir"/>
</telecom>
</contact>
<contact>
<name value="FHIR at EMA"/>
<telecom>
<system value="url"/>
<value value="http://ema.europa.eu/fhir"/>
</telecom>
</contact>
<description
value="EU EPI document type code system, defined in EMA's Referentials Management Service."/>
<caseSensitive value="false"/>
<content value="complete"/>
<count value="9"/>
<concept>
<code value="100000155532"/>
<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"/>
</designation>
<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>
<language value="el"/>
<value value="ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ"/>
</designation>
<designation>
<language value="hu"/>
<value value="ALKALMAZÁSI ELŐÍRÁS"/>
</designation>
<designation>
<language value="is"/>
<value value="SAMANTEKT Á EIGINLEIKUM LYFS"/>
</designation>
<designation>
<language value="ga"/>
<value value="ACHOIMRE AR SHAINTRÉITHE AN TÁIRGE"/>
</designation>
<designation>
<language value="it"/>
<value value="RIASSUNTO DELLE CARATTERISTICHE DEL PRODOTTO"/>
</designation>
<designation>
<language value="lv"/>
<value value="ZĀĻU APRAKSTS"/>
</designation>
<designation>
<language value="lt"/>
<value value="PREPARATO CHARAKTERISTIKŲ SANTRAUKA"/>
</designation>
<designation>
<language value="mt"/>
<value value="SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT"/>
</designation>
<designation>
<language value="no"/>
<value value="PREPARATOMTALE"/>
</designation>
<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="100000155533"/>
<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="100000155534"/>
<display value="Outer Packaging"/>
</concept>
<concept>
<code value="100000155535"/>
<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="100000155537"/>
<display value="Other Product Information"/>
</concept>
<concept>
<code value="100000155538"/>
<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="100000155539"/>
<display value="Combined File of all Documents"/>
</concept>
<concept>
<code value="100000155540"/>
<display value="Mock ups"/>
</concept>
<concept>
<code value="100000155541"/>
<display value="Appendix V"/>
</concept>
</CodeSystem>