Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use International flag

Global Core Electronic Medicinal Product Information (ePI), published by HL7 International - Biomedical Research & Regulation Work Group. This guide is not an authorized publication; it is the continuous build for version 1.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/emedicinal-product-info/ and changes regularly. See the Directory of published versions

: bundle-epi-type1-example

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@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 -------------------------------------------------------------------

 a fhir:Bundle ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "bundle-epi-type1-example"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/bundle-epi-type1"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/bundle-epi-type1>     ] )
  ] ; # 
  fhir:language [ fhir:v "en"] ; # 
  fhir:identifier [
fhir:system [
fhir:v "http://ema.europa.eu/fhir/epiDocument"^^xsd:anyURI ;
fhir:l <http://ema.europa.eu/fhir/epiDocument>     ] ;
fhir:value [ fhir:v "b99c95f8-bb0b-ef11-9f8a-000d3aa845fb" ]
  ] ; # 
  fhir:type [ fhir:v "document"] ; # 
  fhir:timestamp [ fhir:v "2024-05-08T09:21:26.034+00:00"^^xsd:dateTime] ; # 
  fhir:entry ( [
fhir:fullUrl [
fhir:v "urn:uuid:fe63fd6a-afe8-4b61-a203-0cf4a69ffb60"^^xsd:anyURI ;
fhir:l <urn:uuid:fe63fd6a-afe8-4b61-a203-0cf4a69ffb60>     ] ;
    ( fhir:resource <urn:uuid:fe63fd6a-afe8-4b61-a203-0cf4a69ffb60> )
  ] ) . # 

<urn:uuid:fe63fd6a-afe8-4b61-a203-0cf4a69ffb60> a fhir:Composition ;
  fhir:id [ fhir:v "fe63fd6a-afe8-4b61-a203-0cf4a69ffb60"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/composition-epi-type1"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/composition-epi-type1>     ] )
  ] ; # 
  fhir:language [ fhir:v "en"] ; # 
  fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div [ fhir:v "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><a name=\"Composition_fe63fd6a-afe8-4b61-a203-0cf4a69ffb60\"> </a>electronic Product Information (ePI) document</div>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:contained ( [
a fhir:Binary ;
fhir:id [ fhir:v "d15f2fb1-ca0b-ef11-9f89-7c1e5212dc19" ] ;
fhir:contentType [ fhir:v "image/png" ] ;
fhir:data [ fhir:v "iVBORw0KGgoAAAANSUhEUgAAAAEAAAABCAYAAAAfFcSJAAAADUlEQVR42mP8z8BQDwAEhQGAhKw66AAAAABJRU5ErkJggg=="^^xsd:base64Binary ]
  ] ) ; # 
  fhir:identifier ( [
fhir:system [
fhir:v "http://ema.europa.eu/fhir/epiComposition"^^xsd:anyURI ;
fhir:l <http://ema.europa.eu/fhir/epiComposition>     ] ;
fhir:value [ fhir:v "fe63fd6a-afe8-4b61-a203-0cf4a69ffb60" ]
  ] ) ; # 
  fhir:status [ fhir:v "final"] ; # 
  fhir:type [
    ( fhir:coding [
fhir:system [
fhir:v "https://spor.ema.europa.eu/v1/lists/100000155531"^^xsd:anyURI ;
fhir:l <https://spor.ema.europa.eu/v1/lists/100000155531>       ] ;
fhir:code [ fhir:v "100000155538" ] ;
fhir:display [ fhir:v "B. PACKAGE LEAFLET" ]     ] )
  ] ; # 
  fhir:subject ( [
fhir:l fhir:MedicinalProductDefinition/medprod-example ;
fhir:reference [ fhir:v "MedicinalProductDefinition/medprod-example" ]
  ] ) ; # 
  fhir:date [ fhir:v "2024-05-08T09:21:26.034+00:00"^^xsd:dateTime] ; # 
  fhir:author ( [
fhir:l fhir:Organization/mah-example ;
fhir:reference [ fhir:v "Organization/mah-example" ]
  ] ) ; # 
  fhir:title [ fhir:v "Humira 20 mg solution for injection in pre-filled syringe (market authorization)"] ; # 
  fhir:section ( [
fhir:title [ fhir:v "B. PACKAGE LEAFLET" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [
fhir:v "https://spor.ema.europa.eu/v1/lists/100000155531"^^xsd:anyURI ;
fhir:l <https://spor.ema.europa.eu/v1/lists/100000155531>         ] ;
fhir:code [ fhir:v "100000155538" ] ;
fhir:display [ fhir:v "B. PACKAGE LEAFLET" ]       ] )     ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">Package Leaflet Text</div>"^^rdf:XMLLiteral ]     ]
  ] ) . #