Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use
Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use
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
{
"resourceType" : "Bundle",
"id" : "bundle-epi-type2-example",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/bundle-epi-type2"
]
},
"language" : "en",
"identifier" : {
"system" : "http://ema.europa.eu/fhir/epiDocument",
"value" : "type2-bundle-uuid"
},
"type" : "document",
"timestamp" : "2024-05-08T09:21:26.034+00:00",
"entry" : [
{
"fullUrl" : "urn:uuid:comp-type2",
"resource" : {
"resourceType" : "Composition",
"id" : "comp-type2",
"meta" : {
"profile" : [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/composition-epi-type2"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<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>"
},
"contained" : [
{
"resourceType" : "Binary",
"id" : "binary-type2",
"contentType" : "image/png",
"data" : "iVBORw0KGgoAAAANSUhEUgAAAAEAAAABCAYAAAAfFcSJAAAADUlEQVR42mP8z8BQDwAEhQGAhKw66AAAAABJRU5ErkJggg=="
}
],
"status" : "final",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000155531",
"code" : "100000155538",
"display" : "B. PACKAGE LEAFLET"
}
]
},
"subject" : [
{
"reference" : "urn:uuid:mpd-type2"
}
],
"date" : "2024-05-08T09:21:26.034+00:00",
"author" : [
{
"reference" : "urn:uuid:org-type2"
}
],
"title" : "Humira Type 2 Example",
"section" : [
{
"title" : "B. PACKAGE LEAFLET",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000155531",
"code" : "100000155538",
"display" : "B. PACKAGE LEAFLET"
}
]
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Type 2 Content</div>"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:mpd-type2",
"resource" : {
"resourceType" : "MedicinalProductDefinition",
"id" : "mpd-type2",
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<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>"
},
"name" : [
{
"productName" : "Humira 20 mg solution for injection"
}
]
}
},
{
"fullUrl" : "urn:uuid:org-type2",
"resource" : {
"resourceType" : "Organization",
"id" : "org-type2",
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<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>"
},
"name" : "AbbVie Ltd"
}
},
{
"fullUrl" : "urn:uuid:auth-type2",
"resource" : {
"resourceType" : "RegulatedAuthorization",
"id" : "auth-type2",
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<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>"
},
"subject" : [
{
"reference" : "urn:uuid:mpd-type2"
}
],
"holder" : {
"reference" : "urn:uuid:org-type2"
}
}
},
{
"fullUrl" : "urn:uuid:mid-type2",
"resource" : {
"resourceType" : "ManufacturedItemDefinition",
"id" : "mid-type2",
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<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>"
},
"status" : "active",
"manufacturedDoseForm" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/200000000004",
"code" : "100000073863",
"display" : "Solution for injection"
}
]
},
"unitOfPresentation" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/200000000014",
"code" : "200000002150",
"display" : "Syringe"
}
]
}
}
},
{
"fullUrl" : "urn:uuid:ing-type2",
"resource" : {
"resourceType" : "Ingredient",
"id" : "ing-type2",
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<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>"
},
"status" : "active",
"for" : [
{
"reference" : "urn:uuid:mpd-type2"
},
{
"reference" : "urn:uuid:mid-type2"
}
],
"role" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000072050",
"code" : "100000072072",
"display" : "Active"
}
]
},
"substance" : {
"code" : {
"reference" : {
"reference" : "urn:uuid:sub-type2"
}
}
}
}
},
{
"fullUrl" : "urn:uuid:sub-type2",
"resource" : {
"resourceType" : "SubstanceReferenceInformation",
"id" : "sub-type2",
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<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>"
}
}
}
]
}
IG © 2022+ HL7 International - Biomedical Research & Regulation Work Group.
Package hl7.fhir.uv.emedicinal-product-info#1.1.0 based on FHIR 5.0.0.
Generated
2026-01-02
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