{ "description": "EU EPI document type code system, defined in EMA's Referentials Management Service.", "_filename": "CodeSystem-100000155531.json", "package_name": "eu.epi.february2025b", "date": null, "publisher": "European Medicines Agency", "jurisdiction": [ { "text": "European Union" } ], "content": "complete", "name": "EUepirmsdocumenttype", "type": null, "experimental": "false", "resourceType": "CodeSystem", "title": "01 Document Type Code System", "package_version": "1.0.0", "status": "active", "id": "f2b5888c-ce96-44dd-b7af-62e32f9f0a3d", "kind": null, "count": 9, "url": "http://ema.europa.eu/fhir/CodeSystem/100000155531", "concept": [ { "code": "100000155532", "display": "Summary of Product Characteristics", "designation": [ { "value": "SUMMARY OF PRODUCT CHARACTERISTICS", "language": "en" }, { "value": "КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА", "language": "bg" }, { "value": "SAŽETAK OPISA SVOJSTAVA LIJEKA", "language": "hr" }, { "value": "SOUHRN ÚDAJŮ O PŘÍPRAVKU", "language": "cs" }, { "value": "PRODUKTRESUMÉ", "language": "da" }, { "value": "SAMENVATTING VAN DE PRODUCTKENMERKEN", "language": "nl" }, { "value": "RAVIMI OMADUSTE KOKKUVÕTE", "language": "et" }, { "value": "VALMISTEYHTEENVETO", "language": "fi" }, { "value": "RÉSUMÉ DES CARACTÉRISTIQUES DU PRODUIT", "language": "fr" }, { "value": "ZUSAMMENFASSUNG DER MERKMALE DES ARZNEIMITTELS", "language": "de" }, { "value": "ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ", "language": "el" }, { "value": "ALKALMAZÁSI ELŐÍRÁS", "language": "hu" }, { "value": "SAMANTEKT Á EIGINLEIKUM LYFS", "language": "is" }, { "value": "ACHOIMRE AR SHAINTRÉITHE AN TÁIRGE", "language": "ga" }, { "value": "RIASSUNTO DELLE CARATTERISTICHE DEL PRODOTTO", "language": "it" }, { "value": "ZĀĻU APRAKSTS", "language": "lv" }, { "value": "PREPARATO CHARAKTERISTIKŲ SANTRAUKA", "language": "lt" }, { "value": "SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT", "language": "mt" }, { "value": "PREPARATOMTALE", "language": "no" }, { "value": "CHARAKTERYSTYKA PRODUKTU LECZNICZEGO", "language": "pl" }, { "value": "RESUMO DAS CARACTERÍSTICAS DO MEDICAMENTO", "language": "pt" }, { "value": "REZUMATUL CARACTERISTICILOR PRODUSULUI", "language": "ro" }, { "value": "SÚHRN CHARAKTERISTICKÝCH VLASTNOSTÍ LIEKU", "language": "sk" }, { "value": "POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA", "language": "sl" }, { "value": "FICHA TÉCNICA O RESUMEN DE LAS CARACTERÍSTICAS DEL PRODUCTO", "language": "es" }, { "value": "PRODUKTRESUMÉ", "language": "sv" } ] }, { "code": "100000155533", "display": "Annex II", "designation": [ { "value": "ANNEX II", "language": "en" }, { "value": "ПРИЛОЖЕНИЕ II", "language": "bg" }, { "value": "PRILOG II.", "language": "hr" }, { "value": "PŘÍLOHA II", "language": "cs" }, { "value": "BILAG II", "language": "da" }, { "value": "BIJLAGE II", "language": "nl" }, { "value": "II LISA", "language": "et" }, { "value": "LIITE II", "language": "fi" }, { "value": "ANNEXE II", "language": "fr" }, { "value": "ANHANG II", "language": "de" }, { "value": "ΠΑΡΑΡΤΗΜΑ ΙΙ", "language": "el" }, { "value": "II. MELLÉKLET", "language": "hu" }, { "value": "VIÐAUKI II", "language": "is" }, { "value": "IARSCRÍBHINN II", "language": "ga" }, { "value": "ALLEGATO II", "language": "it" }, { "value": "II PIELIKUMS", "language": "lv" }, { "value": "II PRIEDAS", "language": "lt" }, { "value": "ANNESS II", "language": "mt" }, { "value": "VEDLEGG II", "language": "no" }, { "value": "ANEKS II", "language": "pl" }, { "value": "ANEXO II", "language": "pt" }, { "value": "ANEXA II", "language": "ro" }, { "value": "PRÍLOHA II", "language": "sk" }, { "value": "PRILOGA II", "language": "sl" }, { "value": "ANEXO II", "language": "es" }, { "value": "BILAGA II", "language": "sv" } ] }, { "code": "100000155534", "display": "Outer Packaging" }, { "code": "100000155535", "display": "Labelling", "designation": [ { "value": "LABELLING", "language": "en" }, { "value": "ДАННИ ВЪРХУ ОПАКОВКАТА", "language": "bg" }, { "value": "OZNAČIVANJE", "language": "hr" }, { "value": "OZNAČENÍ NA OBALU", "language": "cs" }, { "value": "ETIKETTERING", "language": "da" }, { "value": "ETIKETTERING", "language": "nl" }, { "value": "PAKENDI MÄRGISTUS", "language": "et" }, { "value": "MYYNTIPÄÄLLYSMERKINNÄT", "language": "fi" }, { "value": "ÉTIQUETAGE", "language": "fr" }, { "value": "ETIKETTIERUNG", "language": "de" }, { "value": "ΕΠΙΣΗΜΑΝΣΗ", "language": "el" }, { "value": "CÍMKESZÖVEG", "language": "hu" }, { "value": "ÁLETRANIR", "language": "is" }, { "value": "LIPÉADÚ", "language": "ga" }, { "value": "ETICHETTATURA", "language": "it" }, { "value": "MARĶĒJUMA TEKSTS", "language": "lv" }, { "value": "ŽENKLINIMAS", "language": "lt" }, { "value": "TIKKETTAR", "language": "mt" }, { "value": "MERKING", "language": "no" }, { "value": "OZNAKOWANIE OPAKOWAŃ", "language": "pl" }, { "value": "ROTULAGEM", "language": "pt" }, { "value": "ETICHETAREA", "language": "ro" }, { "value": "OZNAČENIE OBALU", "language": "sk" }, { "value": "OZNAČEVANJE", "language": "sl" }, { "value": "ETIQUETADO", "language": "es" }, { "value": "MÄRKNING", "language": "sv" } ] }, { "code": "100000155537", "display": "Other Product Information" }, { "code": "100000155538", "display": "Package Leaflet", "designation": [ { "value": "PACKAGE LEAFLET", "language": "en" }, { "value": "ЛИСТОВКА", "language": "bg" }, { "value": "UPUTA O LIJEKU", "language": "hr" }, { "value": "PŘÍBALOVÁ INFORMACE", "language": "cs" }, { "value": "INDLÆGSSEDDEL", "language": "da" }, { "value": "BIJSLUITER", "language": "nl" }, { "value": "PAKENDI INFOLEHT", "language": "et" }, { "value": "PAKKAUSSELOSTE", "language": "fi" }, { "value": "NOTICE", "language": "fr" }, { "value": "PACKUNGSBEILAGE", "language": "de" }, { "value": "ΦΥΛΛΟ ΟΔΗΓΙΩΝ ΧΡΗΣΗΣ", "language": "el" }, { "value": "BETEGTÁJÉKOZTATÓ", "language": "hu" }, { "value": "FYLGISEÐILL", "language": "is" }, { "value": "BILEOG PHACÁISTE", "language": "ga" }, { "value": "FOGLIO ILLUSTRATIVO", "language": "it" }, { "value": "LIETOŠANAS INSTRUKCIJA", "language": "lv" }, { "value": "PAKUOTĖS LAPELIS", "language": "lt" }, { "value": "FULJETT TA TAGĦRIF", "language": "mt" }, { "value": "PAKNINGSVEDLEGG", "language": "no" }, { "value": "ULOTKA DLA PACJENTA", "language": "pl" }, { "value": "FOLHETO INFORMATIVO", "language": "pt" }, { "value": "PROSPECTUL", "language": "ro" }, { "value": "PÍSOMNÁ INFORMÁCIA PRE POUŽÍVATEĽA", "language": "sk" }, { "value": "NAVODILO ZA UPORABO", "language": "sl" }, { "value": "PROSPECTO", "language": "es" }, { "value": "BIPACKSEDEL", "language": "sv" } ] }, { "code": "100000155539", "display": "Combined File of all Documents" }, { "code": "100000155540", "display": "Mock ups" }, { "code": "100000155541", "display": "Appendix V" } ], "caseSensitive": false, "version": "1.0.0" }