European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide
1.0.0 - final
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 2026-08-26 |
@prefix fhir: <http://hl7.org/fhir/> . @prefix owl: <http://www.w3.org/2002/07/owl#> . @prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> . @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> . @prefix xsd: <http://www.w3.org/2001/XMLSchema#> . # - resource ------------------------------------------------------------------- <http://hl7.org/fhir/CodeSystem/100000155531> a fhir:CodeSystem ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "100000155531"] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<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><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/></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/></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/></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/></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/></tr></table></div>"^^rdf:XMLLiteral ] ] ; # fhir:url [ fhir:v "http://ema.europa.eu/fhir/CodeSystem/100000155531"^^xsd:anyURI] ; # fhir:version [ fhir:v "1.0.0"] ; # fhir:name [ fhir:v "EUepirmsdocumenttype"] ; # fhir:title [ fhir:v "Document Type"] ; # fhir:status [ fhir:v "active"] ; # fhir:experimental [ fhir:v false] ; # fhir:date [ fhir:v "2026-08-26T09:34:02+01:00"^^xsd:dateTime] ; # fhir:publisher [ fhir:v "European Medicines Agency"] ; # fhir:contact ( [ fhir:name [ fhir:v "European Medicines Agency" ] ; fhir:telecom ( [ fhir:system [ fhir:v "url" ] ; fhir:value [ fhir:v "https://ema.europa.eu/fhir" ] ] ) ] [ fhir:name [ fhir:v "FHIR at EMA" ] ; fhir:telecom ( [ fhir:system [ fhir:v "url" ] ; fhir:value [ fhir:v "http://ema.europa.eu/fhir" ] ] ) ] ) ; # fhir:description [ fhir:v "EU EPI document type code system, defined in EMA's Referentials Management Service."] ; # fhir:caseSensitive [ fhir:v false] ; # fhir:content [ fhir:v "complete"] ; # fhir:count [ fhir:v "9"^^xsd:nonNegativeInteger] ; # fhir:concept ( [ fhir:code [ fhir:v "100000155532" ] ; fhir:display [ fhir:v "Summary of Product Characteristics" ] ; fhir:designation ( [ fhir:language [ fhir:v "en" ] ; fhir:value [ fhir:v "SUMMARY OF PRODUCT CHARACTERISTICS" ] ] [ fhir:language [ fhir:v "bg" ] ; fhir:value [ fhir:v "КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА" ] ] [ fhir:language [ fhir:v "hr" ] ; fhir:value [ fhir:v "SAŽETAK OPISA SVOJSTAVA LIJEKA" ] ] [ fhir:language [ fhir:v "cs" ] ; fhir:value [ fhir:v "SOUHRN ÚDAJŮ O PŘÍPRAVKU" ] ] [ fhir:language [ fhir:v "da" ] ; fhir:value [ fhir:v "PRODUKTRESUMÉ" ] ] [ fhir:language [ fhir:v "nl" ] ; fhir:value [ fhir:v "SAMENVATTING VAN DE PRODUCTKENMERKEN" ] ] [ fhir:language [ fhir:v "et" ] ; fhir:value [ fhir:v "RAVIMI OMADUSTE KOKKUVÕTE" ] ] [ fhir:language [ fhir:v "fi" ] ; fhir:value [ fhir:v "VALMISTEYHTEENVETO" ] ] [ fhir:language [ fhir:v "fr" ] ; fhir:value [ fhir:v "RÉSUMÉ DES CARACTÉRISTIQUES DU PRODUIT" ] ] [ fhir:language [ fhir:v "de" ] ; fhir:value [ fhir:v "ZUSAMMENFASSUNG DER MERKMALE DES ARZNEIMITTELS" ] ] [ fhir:language [ fhir:v "el" ] ; fhir:value [ fhir:v "ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ" ] ] [ fhir:language [ fhir:v "hu" ] ; fhir:value [ fhir:v "ALKALMAZÁSI ELŐÍRÁS" ] ] [ fhir:language [ fhir:v "is" ] ; fhir:value [ fhir:v "SAMANTEKT Á EIGINLEIKUM LYFS" ] ] [ fhir:language [ fhir:v "ga" ] ; fhir:value [ fhir:v "ACHOIMRE AR SHAINTRÉITHE AN TÁIRGE" ] ] [ fhir:language [ fhir:v "it" ] ; fhir:value [ fhir:v "RIASSUNTO DELLE CARATTERISTICHE DEL PRODOTTO" ] ] [ fhir:language [ fhir:v "lv" ] ; fhir:value [ fhir:v "ZĀĻU APRAKSTS" ] ] [ fhir:language [ fhir:v "lt" ] ; fhir:value [ fhir:v "PREPARATO CHARAKTERISTIKŲ SANTRAUKA" ] ] [ fhir:language [ fhir:v "mt" ] ; fhir:value [ fhir:v "SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT" ] ] [ fhir:language [ fhir:v "no" ] ; fhir:value [ fhir:v "PREPARATOMTALE" ] ] [ fhir:language [ fhir:v "pl" ] ; fhir:value [ fhir:v "CHARAKTERYSTYKA PRODUKTU LECZNICZEGO" ] ] [ fhir:language [ fhir:v "pt" ] ; fhir:value [ fhir:v "RESUMO DAS CARACTERÍSTICAS DO MEDICAMENTO" ] ] [ fhir:language [ fhir:v "ro" ] ; fhir:value [ fhir:v "REZUMATUL CARACTERISTICILOR PRODUSULUI" ] ] [ fhir:language [ fhir:v "sk" ] ; fhir:value [ fhir:v "SÚHRN CHARAKTERISTICKÝCH VLASTNOSTÍ LIEKU" ] ] [ fhir:language [ fhir:v "sl" ] ; fhir:value [ fhir:v "POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA" ] ] [ fhir:language [ fhir:v "es" ] ; fhir:value [ fhir:v "FICHA TÉCNICA O RESUMEN DE LAS CARACTERÍSTICAS DEL PRODUCTO" ] ] [ fhir:language [ fhir:v "sv" ] ; fhir:value [ fhir:v "PRODUKTRESUMÉ" ] ] ) ] [ fhir:code [ fhir:v "100000155533" ] ; fhir:display [ fhir:v "Annex II" ] ; fhir:designation ( [ fhir:language [ fhir:v "en" ] ; fhir:value [ fhir:v "ANNEX II" ] ] [ fhir:language [ fhir:v "bg" ] ; fhir:value [ fhir:v "ПРИЛОЖЕНИЕ II" ] ] [ fhir:language [ fhir:v "hr" ] ; fhir:value [ fhir:v "PRILOG II." ] ] [ fhir:language [ fhir:v "cs" ] ; fhir:value [ fhir:v "PŘÍLOHA II" ] ] [ fhir:language [ fhir:v "da" ] ; fhir:value [ fhir:v "BILAG II" ] ] [ fhir:language [ fhir:v "nl" ] ; fhir:value [ fhir:v "BIJLAGE II" ] ] [ fhir:language [ fhir:v "et" ] ; fhir:value [ fhir:v "II LISA" ] ] [ fhir:language [ fhir:v "fi" ] ; fhir:value [ fhir:v "LIITE II" ] ] [ fhir:language [ fhir:v "fr" ] ; fhir:value [ fhir:v "ANNEXE II" ] ] [ fhir:language [ fhir:v "de" ] ; fhir:value [ fhir:v "ANHANG II" ] ] [ fhir:language [ fhir:v "el" ] ; fhir:value [ fhir:v "ΠΑΡΑΡΤΗΜΑ ΙΙ" ] ] [ fhir:language [ fhir:v "hu" ] ; fhir:value [ fhir:v "II. MELLÉKLET" ] ] [ fhir:language [ fhir:v "is" ] ; fhir:value [ fhir:v "VIÐAUKI II" ] ] [ fhir:language [ fhir:v "ga" ] ; fhir:value [ fhir:v "IARSCRÍBHINN II" ] ] [ fhir:language [ fhir:v "it" ] ; fhir:value [ fhir:v "ALLEGATO II" ] ] [ fhir:language [ fhir:v "lv" ] ; fhir:value [ fhir:v "II PIELIKUMS" ] ] [ fhir:language [ fhir:v "lt" ] ; fhir:value [ fhir:v "II PRIEDAS" ] ] [ fhir:language [ fhir:v "mt" ] ; fhir:value [ fhir:v "ANNESS II" ] ] [ fhir:language [ fhir:v "no" ] ; fhir:value [ fhir:v "VEDLEGG II" ] ] [ fhir:language [ fhir:v "pl" ] ; fhir:value [ fhir:v "ANEKS II" ] ] [ fhir:language [ fhir:v "pt" ] ; fhir:value [ fhir:v "ANEXO II" ] ] [ fhir:language [ fhir:v "ro" ] ; fhir:value [ fhir:v "ANEXA II" ] ] [ fhir:language [ fhir:v "sk" ] ; fhir:value [ fhir:v "PRÍLOHA II" ] ] [ fhir:language [ fhir:v "sl" ] ; fhir:value [ fhir:v "PRILOGA II" ] ] [ fhir:language [ fhir:v "es" ] ; fhir:value [ fhir:v "ANEXO II" ] ] [ fhir:language [ fhir:v "sv" ] ; fhir:value [ fhir:v "BILAGA II" ] ] ) ] [ fhir:code [ fhir:v "100000155534" ] ; fhir:display [ fhir:v "Outer Packaging" ] ] [ fhir:code [ fhir:v "100000155535" ] ; fhir:display [ fhir:v "Labelling" ] ; fhir:designation ( [ fhir:language [ fhir:v "en" ] ; fhir:value [ fhir:v "LABELLING" ] ] [ fhir:language [ fhir:v "bg" ] ; fhir:value [ fhir:v "ДАННИ ВЪРХУ ОПАКОВКАТА" ] ] [ fhir:language [ fhir:v "hr" ] ; fhir:value [ fhir:v "OZNAČIVANJE" ] ] [ fhir:language [ fhir:v "cs" ] ; fhir:value [ fhir:v "OZNAČENÍ NA OBALU" ] ] [ fhir:language [ fhir:v "da" ] ; fhir:value [ fhir:v "ETIKETTERING" ] ] [ fhir:language [ fhir:v "nl" ] ; fhir:value [ fhir:v "ETIKETTERING" ] ] [ fhir:language [ fhir:v "et" ] ; fhir:value [ fhir:v "PAKENDI MÄRGISTUS" ] ] [ fhir:language [ fhir:v "fi" ] ; fhir:value [ fhir:v "MYYNTIPÄÄLLYSMERKINNÄT" ] ] [ fhir:language [ fhir:v "fr" ] ; fhir:value [ fhir:v "ÉTIQUETAGE" ] ] [ fhir:language [ fhir:v "de" ] ; fhir:value [ fhir:v "ETIKETTIERUNG" ] ] [ fhir:language [ fhir:v "el" ] ; fhir:value [ fhir:v "ΕΠΙΣΗΜΑΝΣΗ" ] ] [ fhir:language [ fhir:v "hu" ] ; fhir:value [ fhir:v "CÍMKESZÖVEG" ] ] [ fhir:language [ fhir:v "is" ] ; fhir:value [ fhir:v "ÁLETRANIR" ] ] [ fhir:language [ fhir:v "ga" ] ; fhir:value [ fhir:v "LIPÉADÚ" ] ] [ fhir:language [ fhir:v "it" ] ; fhir:value [ fhir:v "ETICHETTATURA" ] ] [ fhir:language [ fhir:v "lv" ] ; fhir:value [ fhir:v "MARĶĒJUMA TEKSTS" ] ] [ fhir:language [ fhir:v "lt" ] ; fhir:value [ fhir:v "ŽENKLINIMAS" ] ] [ fhir:language [ fhir:v "mt" ] ; fhir:value [ fhir:v "TIKKETTAR" ] ] [ fhir:language [ fhir:v "no" ] ; fhir:value [ fhir:v "MERKING" ] ] [ fhir:language [ fhir:v "pl" ] ; fhir:value [ fhir:v "OZNAKOWANIE OPAKOWAŃ" ] ] [ fhir:language [ fhir:v "pt" ] ; fhir:value [ fhir:v "ROTULAGEM" ] ] [ fhir:language [ fhir:v "ro" ] ; fhir:value [ fhir:v "ETICHETAREA" ] ] [ fhir:language [ fhir:v "sk" ] ; fhir:value [ fhir:v "OZNAČENIE OBALU" ] ] [ fhir:language [ fhir:v "sl" ] ; fhir:value [ fhir:v "OZNAČEVANJE" ] ] [ fhir:language [ fhir:v "es" ] ; fhir:value [ fhir:v "ETIQUETADO" ] ] [ fhir:language [ fhir:v "sv" ] ; fhir:value [ fhir:v "MÄRKNING" ] ] ) ] [ fhir:code [ fhir:v "100000155537" ] ; fhir:display [ fhir:v "Other Product Information" ] ] [ fhir:code [ fhir:v "100000155538" ] ; fhir:display [ fhir:v "Package Leaflet" ] ; fhir:designation ( [ fhir:language [ fhir:v "en" ] ; fhir:value [ fhir:v "PACKAGE LEAFLET" ] ] [ fhir:language [ fhir:v "bg" ] ; fhir:value [ fhir:v "ЛИСТОВКА" ] ] [ fhir:language [ fhir:v "hr" ] ; fhir:value [ fhir:v "UPUTA O LIJEKU" ] ] [ fhir:language [ fhir:v "cs" ] ; fhir:value [ fhir:v "PŘÍBALOVÁ INFORMACE" ] ] [ fhir:language [ fhir:v "da" ] ; fhir:value [ fhir:v "INDLÆGSSEDDEL" ] ] [ fhir:language [ fhir:v "nl" ] ; fhir:value [ fhir:v "BIJSLUITER" ] ] [ fhir:language [ fhir:v "et" ] ; fhir:value [ fhir:v "PAKENDI INFOLEHT" ] ] [ fhir:language [ fhir:v "fi" ] ; fhir:value [ fhir:v "PAKKAUSSELOSTE" ] ] [ fhir:language [ fhir:v "fr" ] ; fhir:value [ fhir:v "NOTICE" ] ] [ fhir:language [ fhir:v "de" ] ; fhir:value [ fhir:v "PACKUNGSBEILAGE" ] ] [ fhir:language [ fhir:v "el" ] ; fhir:value [ fhir:v "ΦΥΛΛΟ ΟΔΗΓΙΩΝ ΧΡΗΣΗΣ" ] ] [ fhir:language [ fhir:v "hu" ] ; fhir:value [ fhir:v "BETEGTÁJÉKOZTATÓ" ] ] [ fhir:language [ fhir:v "is" ] ; fhir:value [ fhir:v "FYLGISEÐILL" ] ] [ fhir:language [ fhir:v "ga" ] ; fhir:value [ fhir:v "BILEOG PHACÁISTE" ] ] [ fhir:language [ fhir:v "it" ] ; fhir:value [ fhir:v "FOGLIO ILLUSTRATIVO" ] ] [ fhir:language [ fhir:v "lv" ] ; fhir:value [ fhir:v "LIETOŠANAS INSTRUKCIJA" ] ] [ fhir:language [ fhir:v "lt" ] ; fhir:value [ fhir:v "PAKUOTĖS LAPELIS" ] ] [ fhir:language [ fhir:v "mt" ] ; fhir:value [ fhir:v "FULJETT TA TAGĦRIF" ] ] [ fhir:language [ fhir:v "no" ] ; fhir:value [ fhir:v "PAKNINGSVEDLEGG" ] ] [ fhir:language [ fhir:v "pl" ] ; fhir:value [ fhir:v "ULOTKA DLA PACJENTA" ] ] [ fhir:language [ fhir:v "pt" ] ; fhir:value [ fhir:v "FOLHETO INFORMATIVO" ] ] [ fhir:language [ fhir:v "ro" ] ; fhir:value [ fhir:v "PROSPECTUL" ] ] [ fhir:language [ fhir:v "sk" ] ; fhir:value [ fhir:v "PÍSOMNÁ INFORMÁCIA PRE POUŽÍVATEĽA" ] ] [ fhir:language [ fhir:v "sl" ] ; fhir:value [ fhir:v "NAVODILO ZA UPORABO" ] ] [ fhir:language [ fhir:v "es" ] ; fhir:value [ fhir:v "PROSPECTO" ] ] [ fhir:language [ fhir:v "sv" ] ; fhir:value [ fhir:v "BIPACKSEDEL" ] ] ) ] [ fhir:code [ fhir:v "100000155539" ] ; fhir:display [ fhir:v "Combined File of all Documents" ] ] [ fhir:code [ fhir:v "100000155540" ] ; fhir:display [ fhir:v "Mock ups" ] ] [ fhir:code [ fhir:v "100000155541" ] ; fhir:display [ fhir:v "Appendix V" ] ] ) . #
IG © 2026+ European Medicines Agency. Package EUePI#1.0.0 based on FHIR 5.0.0. Generated 2026-08-26
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