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-type1-example-morphine",
"language" : "en",
"type" : "document",
"timestamp" : "2023-11-27T00:00:00Z",
"entry" : [
{
"resource" : {
"resourceType" : "Composition",
"id" : "composition-morphine-type1",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/composition-epi-type1"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Composition_composition-morphine-type1\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition composition-morphine-type1</b></p><a name=\"composition-morphine-type1\"> </a><a name=\"hccomposition-morphine-type1\"> </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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-composition-epi-type1.html\">Composition - ePI Type 1</a></p></div><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000155531 100000155538}\">Package Leaflet</span></p><p><b>date</b>: 2023-11-27</p><p><b>author</b>: <a href=\"Bundle-bundle-epi-type1-example-morphine.html#Organization_LOC-100001090\">Organization Unimedic Pharma AB</a></p><p><b>title</b>: Package Leaflet: Information for the user - Morphine Unimedic 1 mg/ml</p></div>"
},
"status" : "final",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000155531",
"code" : "100000155538",
"display" : "Package Leaflet"
}
]
},
"subject" : [
{
"reference" : "MedicinalProductDefinition/MorphineUni-1mgml-Solution-SE-BS-MPD"
}
],
"date" : "2023-11-27",
"author" : [
{
"reference" : "Organization/LOC-100001090"
}
],
"title" : "Package Leaflet: Information for the user - Morphine Unimedic 1 mg/ml",
"section" : [
{
"title" : "1. What Morphine Unimedic is and what it is used for",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/200000029659",
"code" : "200000029895",
"display" : "What X is and what it is used for"
}
]
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Morphine Unimedic contains the active substance morphine hydrochloride. It is an opioid analgesic used for severe pain.</p></div>"
}
},
{
"title" : "2. What you need to know before you take Morphine Unimedic",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/200000029659",
"code" : "200000029896",
"display" : "What you need to know before you take X"
}
]
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Do not take if allergic to morphine.</p></div>"
}
},
{
"title" : "3. How to take Morphine Unimedic",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/200000029659",
"code" : "200000029905",
"display" : "How to take X"
}
]
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Use as directed by your doctor.</p></div>"
}
},
{
"title" : "4. Possible side effects",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/200000029659",
"code" : "200000029906",
"display" : "Possible side effects"
}
]
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>May cause nausea, vomiting, or constipation.</p></div>"
}
},
{
"title" : "5. How to store Morphine Unimedic",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/200000029659",
"code" : "200000029907",
"display" : "How to store X"
}
]
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Keep out of reach of children.</p></div>"
}
},
{
"title" : "6. Contents of the pack and other information",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/200000029659",
"code" : "200000029908",
"display" : "Contents of the pack and other information"
}
]
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Content: Morphine hydrochloride 1 mg/ml.</p></div>"
}
}
]
}
},
{
"resource" : {
"resourceType" : "Organization",
"id" : "LOC-100001090",
"meta" : {
"versionId" : "1",
"lastUpdated" : "2025-11-26T09:20:05.357+00:00",
"profile" : [
"http://unicom-project.eu/fhir/StructureDefinition/PPLOrganization"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_LOC-100001090\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization LOC-100001090</b></p><a name=\"LOC-100001090\"> </a><a name=\"hcLOC-100001090\"> </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\">version: 1; Last updated: 2025-11-26 09:20:05+0000</p><p style=\"margin-bottom: 0px\">Profile: <code>http://unicom-project.eu/fhir/StructureDefinition/PPLOrganization</code></p></div><p><b>identifier</b>: <code>https://spor.ema.europa.eu/v1/locations</code>/LOC-100001090</p><p><b>name</b>: Unimedic Pharma AB</p></div>"
},
"identifier" : [
{
"system" : "https://spor.ema.europa.eu/v1/locations",
"value" : "LOC-100001090"
}
],
"name" : "Unimedic Pharma AB"
}
}
]
}
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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