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-type2-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-type2-example"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/bundle-epi-type2"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/bundle-epi-type2>     ] )
  ] ; # 
  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 "type2-bundle-uuid" ]
  ] ; # 
  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:comp-type2"^^xsd:anyURI ;
fhir:l <urn:uuid:comp-type2>     ] ;
    ( fhir:resource <urn:uuid:comp-type2> )
  ] [
fhir:fullUrl [
fhir:v "urn:uuid:mpd-type2"^^xsd:anyURI ;
fhir:l <urn:uuid:mpd-type2>     ] ;
    ( fhir:resource <urn:uuid:mpd-type2> )
  ] [
fhir:fullUrl [
fhir:v "urn:uuid:org-type2"^^xsd:anyURI ;
fhir:l <urn:uuid:org-type2>     ] ;
    ( fhir:resource <urn:uuid:org-type2> )
  ] [
fhir:fullUrl [
fhir:v "urn:uuid:auth-type2"^^xsd:anyURI ;
fhir:l <urn:uuid:auth-type2>     ] ;
    ( fhir:resource <urn:uuid:auth-type2> )
  ] [
fhir:fullUrl [
fhir:v "urn:uuid:mid-type2"^^xsd:anyURI ;
fhir:l <urn:uuid:mid-type2>     ] ;
    ( fhir:resource <urn:uuid:mid-type2> )
  ] [
fhir:fullUrl [
fhir:v "urn:uuid:ing-type2"^^xsd:anyURI ;
fhir:l <urn:uuid:ing-type2>     ] ;
    ( fhir:resource <urn:uuid:ing-type2> )
  ] [
fhir:fullUrl [
fhir:v "urn:uuid:sub-type2"^^xsd:anyURI ;
fhir:l <urn:uuid:sub-type2>     ] ;
    ( fhir:resource <urn:uuid:sub-type2> )
  ] ) . # 

<urn:uuid:comp-type2> a fhir:Composition ;
  fhir:id [ fhir:v "comp-type2"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/composition-epi-type2"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/composition-epi-type2>     ] )
  ] ; # 
  fhir:language [ fhir:v "en"] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"en\" lang=\"en\"><a name=\"Composition_comp-type2\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition comp-type2</b></p><a name=\"comp-type2\"> </a><a name=\"hccomp-type2\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Language: en</p><p style=\"margin-bottom: 0px\">Profile: <code>http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/composition-epi-type2</code></p></div><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000155531 100000155538}\">B. PACKAGE LEAFLET</span></p><p><b>date</b>: 2024-05-08 09:21:26+0000</p><p><b>author</b>: <a href=\"Bundle-bundle-epi-type2-example.html#urn-uuid-org-type2\">Organization AbbVie Ltd</a></p><p><b>title</b>: Humira Type 2 Example</p><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Binary #binary-type2</b></p><a name=\"comp-type2/binary-type2\"> </a><a name=\"hccomp-type2/binary-type2\"> </a><p><b>contentType</b>: image/png</p><p><b>data</b>: <code>iVBORw0KGgoAAAANSUhEUgAAAAEAAAABCAYAAAAfFcSJAAAADUlEQVR42mP8z8BQDwAEhQGAhKw66AAAAABJRU5ErkJggg==</code></p></blockquote></div>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:contained ( [
a fhir:Binary ;
fhir:id [ fhir:v "binary-type2" ] ;
fhir:contentType [ fhir:v "image/png" ] ;
fhir:data [ fhir:v "iVBORw0KGgoAAAANSUhEUgAAAAEAAAABCAYAAAAfFcSJAAAADUlEQVR42mP8z8BQDwAEhQGAhKw66AAAAABJRU5ErkJggg=="^^xsd:base64Binary ]
  ] ) ; # 
  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 <urn:uuid:mpd-type2> ;
fhir:reference [ fhir:v "urn:uuid:mpd-type2" ]
  ] ) ; # 
  fhir:date [ fhir:v "2024-05-08T09:21:26.034+00:00"^^xsd:dateTime] ; # 
  fhir:author ( [
fhir:l <urn:uuid:org-type2> ;
fhir:reference [ fhir:v "urn:uuid:org-type2" ]
  ] ) ; # 
  fhir:title [ fhir:v "Humira Type 2 Example"] ; # 
  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\">Type 2 Content</div>"^^rdf:XMLLiteral ]     ]
  ] ) . # 

<urn:uuid:mpd-type2> a fhir:MedicinalProductDefinition ;
  fhir:id [ fhir:v "mpd-type2"] ; # 
  fhir:language [ fhir:v "en"] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_mpd-type2\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition mpd-type2</b></p><a name=\"mpd-type2\"> </a><a name=\"hcmpd-type2\"> </a><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>ProductName</b></td></tr><tr><td style=\"display: none\">*</td><td>Humira 20 mg solution for injection</td></tr></table></div>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:name ( [
fhir:productName [ fhir:v "Humira 20 mg solution for injection" ]
  ] ) . # 

<urn:uuid:org-type2> a fhir:Organization ;
  fhir:id [ fhir:v "org-type2"] ; # 
  fhir:language [ fhir:v "en"] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_org-type2\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization org-type2</b></p><a name=\"org-type2\"> </a><a name=\"hcorg-type2\"> </a><p><b>name</b>: AbbVie Ltd</p></div>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:name [ fhir:v "AbbVie Ltd"] . # 

<urn:uuid:auth-type2> a fhir:RegulatedAuthorization ;
  fhir:id [ fhir:v "auth-type2"] ; # 
  fhir:language [ fhir:v "en"] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"RegulatedAuthorization_auth-type2\"> </a><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization auth-type2</b></p><a name=\"auth-type2\"> </a><a name=\"hcauth-type2\"> </a><p><b>subject</b>: <a href=\"Bundle-bundle-epi-type2-example.html#urn-uuid-mpd-type2\">MedicinalProductDefinition</a></p><p><b>holder</b>: <a href=\"Bundle-bundle-epi-type2-example.html#urn-uuid-org-type2\">Organization AbbVie Ltd</a></p></div>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:subject ( [
fhir:l <urn:uuid:mpd-type2> ;
fhir:reference [ fhir:v "urn:uuid:mpd-type2" ]
  ] ) ; # 
  fhir:holder [
fhir:l <urn:uuid:org-type2> ;
fhir:reference [ fhir:v "urn:uuid:org-type2" ]
  ] . # 

<urn:uuid:mid-type2> a fhir:ManufacturedItemDefinition ;
  fhir:id [ fhir:v "mid-type2"] ; # 
  fhir:language [ fhir:v "en"] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ManufacturedItemDefinition_mid-type2\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ManufacturedItemDefinition mid-type2</b></p><a name=\"mid-type2\"> </a><a name=\"hcmid-type2\"> </a><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/200000000004 100000073863}\">Solution for injection</span></p><p><b>unitOfPresentation</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/200000000014 200000002150}\">Syringe</span></p></div>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:manufacturedDoseForm [
    ( fhir:coding [
fhir:system [
fhir:v "https://spor.ema.europa.eu/v1/lists/200000000004"^^xsd:anyURI ;
fhir:l <https://spor.ema.europa.eu/v1/lists/200000000004>       ] ;
fhir:code [ fhir:v "100000073863" ] ;
fhir:display [ fhir:v "Solution for injection" ]     ] )
  ] ; # 
  fhir:unitOfPresentation [
    ( fhir:coding [
fhir:system [
fhir:v "https://spor.ema.europa.eu/v1/lists/200000000014"^^xsd:anyURI ;
fhir:l <https://spor.ema.europa.eu/v1/lists/200000000014>       ] ;
fhir:code [ fhir:v "200000002150" ] ;
fhir:display [ fhir:v "Syringe" ]     ] )
  ] . # 

<urn:uuid:ing-type2> a fhir:Ingredient ;
  fhir:id [ fhir:v "ing-type2"] ; # 
  fhir:language [ fhir:v "en"] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_ing-type2\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient ing-type2</b></p><a name=\"ing-type2\"> </a><a name=\"hcing-type2\"> </a><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"Bundle-bundle-epi-type2-example.html#urn-uuid-mpd-type2\">MedicinalProductDefinition</a></li><li><a href=\"Bundle-bundle-epi-type2-example.html#urn-uuid-mid-type2\">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Solution for injection; unitOfPresentation = Syringe</a></li></ul><p><b>role</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000072050 100000072072}\">Active</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-bundle-epi-type2-example.html#urn-uuid-sub-type2\">SubstanceReferenceInformation</a></td></tr></table></blockquote></div>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:for ( [
fhir:l <urn:uuid:mpd-type2> ;
fhir:reference [ fhir:v "urn:uuid:mpd-type2" ]
  ] [
fhir:l <urn:uuid:mid-type2> ;
fhir:reference [ fhir:v "urn:uuid:mid-type2" ]
  ] ) ; # 
  fhir:role [
    ( fhir:coding [
fhir:system [
fhir:v "https://spor.ema.europa.eu/v1/lists/100000072050"^^xsd:anyURI ;
fhir:l <https://spor.ema.europa.eu/v1/lists/100000072050>       ] ;
fhir:code [ fhir:v "100000072072" ] ;
fhir:display [ fhir:v "Active" ]     ] )
  ] ; # 
  fhir:substance [
fhir:code [
fhir:reference [
fhir:l <urn:uuid:sub-type2> ;
fhir:reference [ fhir:v "urn:uuid:sub-type2" ]       ]     ]
  ] . # 

<urn:uuid:sub-type2> a fhir:SubstanceReferenceInformation ;
  fhir:id [ fhir:v "sub-type2"] ; # 
  fhir:language [ fhir:v "en"] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceReferenceInformation_sub-type2\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceReferenceInformation sub-type2</b></p><a name=\"sub-type2\"> </a><a name=\"hcsub-type2\"> </a></div>"^^rdf:XMLLiteral ]
  ] . #