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-morphine",
"language" : "en",
"type" : "document",
"timestamp" : "2023-11-27T00:00:00Z",
"entry" : [
{
"resource" : {
"resourceType" : "Composition",
"id" : "composition-morphine-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\"><a name=\"Composition_composition-morphine-type2\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition composition-morphine-type2</b></p><a name=\"composition-morphine-type2\"> </a><a name=\"hccomposition-morphine-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\"/><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}\">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" : "MedicinalProductDefinition",
"id" : "MorphineUni-1mgml-Solution-SE-BS-MPD",
"meta" : {
"versionId" : "1",
"lastUpdated" : "2025-11-26T09:21:19.300+00:00",
"profile" : [
"http://unicom-project.eu/fhir/StructureDefinition/PPLMedicinalProductDefinition"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_MorphineUni-1mgml-Solution-SE-BS-MPD\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition MorphineUni-1mgml-Solution-SE-BS-MPD</b></p><a name=\"MorphineUni-1mgml-Solution-SE-BS-MPD\"> </a><a name=\"hcMorphineUni-1mgml-Solution-SE-BS-MPD\"> </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 09:21:19+0000</p><p style=\"margin-bottom: 0px\">Profile: <code>http://unicom-project.eu/fhir/StructureDefinition/PPLMedicinalProductDefinition</code></p></div><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/mpId</code>/SE-100001732-00056117, <code>http://ema.europa.eu/fhir/eurdId</code>/10549</p><p><b>domain</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000000004 100000000012}\">Human use</span></p><p><b>status</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/200000005003 200000005004}\">Current</span></p><p><b>combinedPharmaceuticalDoseForm</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/200000000004~200000000006~200000000007~200000000008 100000073863}\">Solution for injection</span></p><p><b>indication</b>: </p><div><p>Morphine Unimedic är indikerat för behandling av svår postoperativ och posttraumatisk smärta och svår opioidkänslig smärta såsom smärta vid cancer.</p>\n</div><p><b>legalStatusOfSupply</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000072051 100000072085}\">Medicinal product subject to special medical prescription</span></p><p><b>classification</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000093533 100000097139}\">morphine</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Morphine Unimedic 1 mg/ml injektionsvätska, lösning</p><blockquote><p><b>part</b></p><p><b>part</b>: Morphine Unimedic</p><p><b>type</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/220000000000 220000000003}\">Scientific name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 1 mg/ml</p><p><b>type</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/220000000000 220000000004}\">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: Injektionsvätska, lösning</p><p><b>type</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/220000000000 220000000005}\">Pharmaceutical dose form part</span></p></blockquote><h3>Usages</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Country</b></td><td><b>Language</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000000002 100000000535}\">Kingdom of Sweden</span></td><td><span title=\"Codes:{urn:ietf:bcp:47 sv}\">Swedish</span></td></tr></table></blockquote></div>"
},
"identifier" : [
{
"system" : "http://ema.europa.eu/fhir/mpId",
"value" : "SE-100001732-00056117"
},
{
"system" : "http://ema.europa.eu/fhir/eurdId",
"value" : "10549"
}
],
"domain" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000000004",
"code" : "100000000012",
"display" : "Human use"
}
]
},
"status" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/200000005003",
"code" : "200000005004",
"display" : "Current"
}
]
},
"combinedPharmaceuticalDoseForm" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/200000000004~200000000006~200000000007~200000000008",
"code" : "100000073863",
"display" : "Solution for injection"
}
]
},
"indication" : "Morphine Unimedic är indikerat för behandling av svår postoperativ och posttraumatisk smärta och svår opioidkänslig smärta såsom smärta vid cancer.",
"legalStatusOfSupply" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000072051",
"code" : "100000072085",
"display" : "Medicinal product subject to special medical prescription"
}
]
},
"classification" : [
{
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000093533",
"code" : "100000097139",
"display" : "morphine"
}
]
}
],
"name" : [
{
"productName" : "Morphine Unimedic 1 mg/ml injektionsvätska, lösning",
"part" : [
{
"part" : "Morphine Unimedic",
"type" : {
"coding" : [
{
"system" : "http://spor.ema.europa.eu/v1/lists/220000000000",
"code" : "220000000003",
"display" : "Scientific name part"
}
]
}
},
{
"part" : "1 mg/ml",
"type" : {
"coding" : [
{
"system" : "http://spor.ema.europa.eu/v1/lists/220000000000",
"code" : "220000000004",
"display" : "Strength part"
}
]
}
},
{
"part" : "Injektionsvätska, lösning",
"type" : {
"coding" : [
{
"system" : "http://spor.ema.europa.eu/v1/lists/220000000000",
"code" : "220000000005",
"display" : "Pharmaceutical dose form part"
}
]
}
}
],
"usage" : [
{
"country" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000000002",
"code" : "100000000535",
"display" : "Kingdom of Sweden"
}
]
},
"language" : {
"coding" : [
{
"system" : "urn:ietf:bcp:47",
"code" : "sv",
"display" : "Swedish"
}
]
}
}
]
}
]
}
},
{
"resource" : {
"resourceType" : "RegulatedAuthorization",
"id" : "MorphineUni-1mgml-Solution-SE-BS-RA",
"meta" : {
"versionId" : "1",
"lastUpdated" : "2025-11-26T09:23:15.251+00:00",
"profile" : [
"http://unicom-project.eu/fhir/StructureDefinition/PPLRegulatedAuthorization"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"RegulatedAuthorization_MorphineUni-1mgml-Solution-SE-BS-RA\"> </a><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization MorphineUni-1mgml-Solution-SE-BS-RA</b></p><a name=\"MorphineUni-1mgml-Solution-SE-BS-RA\"> </a><a name=\"hcMorphineUni-1mgml-Solution-SE-BS-RA\"> </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 09:23:15+0000</p><p style=\"margin-bottom: 0px\">Profile: <code>http://unicom-project.eu/fhir/StructureDefinition/PPLRegulatedAuthorization</code></p></div><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/marketingAuthorizationNumber</code>/56117</p><p><b>subject</b>: <a href=\"Bundle-bundle-epi-type2-example-morphine.html#MedicinalProductDefinition_MorphineUni-1mgml-Solution-SE-BS-MPD\">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100001732-00056117,http://ema.europa.eu/fhir/eurdId#10549; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Solution for injection; indication = Morphine Unimedic är indikerat för behandling av svår postoperativ och posttraumatisk smärta och svår opioidkänslig smärta såsom smärta vid cancer.; legalStatusOfSupply = Medicinal product subject to special medical prescription; classification = morphine</a></p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/220000000060 220000000061}\">Marketing Authorisation</span></p><p><b>region</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000000002 100000000535}\">Kingdom of Sweden</span></p><p><b>status</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000072049 100000072099}\">Valid</span></p><p><b>statusDate</b>: 2018-04-06</p><p><b>holder</b>: <a href=\"Bundle-bundle-epi-type1-example-morphine.html#Organization_LOC-100001090\">Organization Unimedic Pharma AB</a></p><h3>Cases</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Date[x]</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://ema.europa.eu/fhir/authorisationDateType dateOfFirstAuthorisation}\">First Authorisation</span></td><td>2018-04-06</td></tr></table></div>"
},
"identifier" : [
{
"system" : "http://ema.europa.eu/fhir/marketingAuthorizationNumber",
"value" : "56117"
}
],
"subject" : [
{
"reference" : "MedicinalProductDefinition/MorphineUni-1mgml-Solution-SE-BS-MPD"
}
],
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/220000000060",
"code" : "220000000061",
"display" : "Marketing Authorisation"
}
]
},
"region" : [
{
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000000002",
"code" : "100000000535",
"display" : "Kingdom of Sweden"
}
]
}
],
"status" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000072049",
"code" : "100000072099",
"display" : "Valid"
}
]
},
"statusDate" : "2018-04-06",
"holder" : {
"reference" : "Organization/LOC-100001090"
},
"case" : {
"type" : {
"coding" : [
{
"system" : "https://ema.europa.eu/fhir/authorisationDateType",
"code" : "dateOfFirstAuthorisation",
"display" : "First Authorisation"
}
]
},
"dateDateTime" : "2018-04-06"
}
}
},
{
"resource" : {
"resourceType" : "AdministrableProductDefinition",
"id" : "MorphineUni-1mgml-Solution-SE-BS-APD",
"meta" : {
"versionId" : "1",
"lastUpdated" : "2025-11-26T09:23:58.134+00:00",
"profile" : [
"http://unicom-project.eu/fhir/StructureDefinition/PPLAdministrableProductDefinition"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"AdministrableProductDefinition_MorphineUni-1mgml-Solution-SE-BS-APD\"> </a><p class=\"res-header-id\"><b>Generated Narrative: AdministrableProductDefinition MorphineUni-1mgml-Solution-SE-BS-APD</b></p><a name=\"MorphineUni-1mgml-Solution-SE-BS-APD\"> </a><a name=\"hcMorphineUni-1mgml-Solution-SE-BS-APD\"> </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 09:23:58+0000</p><p style=\"margin-bottom: 0px\">Profile: <code>http://unicom-project.eu/fhir/StructureDefinition/PPLAdministrableProductDefinition</code></p></div><p><b>status</b>: Active</p><p><b>formOf</b>: <a href=\"Bundle-bundle-epi-type2-example-morphine.html#MedicinalProductDefinition_MorphineUni-1mgml-Solution-SE-BS-MPD\">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100001732-00056117,http://ema.europa.eu/fhir/eurdId#10549; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Solution for injection; indication = Morphine Unimedic är indikerat för behandling av svår postoperativ och posttraumatisk smärta och svår opioidkänslig smärta såsom smärta vid cancer.; legalStatusOfSupply = Medicinal product subject to special medical prescription; classification = morphine</a></p><p><b>administrableDoseForm</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/200000000004 100000073863}\">Solution for injection</span></p><p><b>producedFrom</b>: <a href=\"Bundle-bundle-epi-type2-example-morphine.html#ManufacturedItemDefinition_MorphineUni-1mgml-Solution-SE-BS-MID\">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Solution for injection; unitOfPresentation = Ampoule</a></p><h3>RouteOfAdministrations</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000073345 100000073633}, {https://spor.ema.europa.eu/v1/lists/100000073345 100000073600}, {https://spor.ema.europa.eu/v1/lists/100000073345 100000073611}, {https://spor.ema.europa.eu/v1/lists/100000073345 100000073572}\">Subcutaneous use</span></td></tr></table></div>"
},
"status" : "active",
"formOf" : [
{
"reference" : "MedicinalProductDefinition/MorphineUni-1mgml-Solution-SE-BS-MPD"
}
],
"administrableDoseForm" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/200000000004",
"code" : "100000073863",
"display" : "Solution for injection"
}
]
},
"producedFrom" : [
{
"reference" : "ManufacturedItemDefinition/MorphineUni-1mgml-Solution-SE-BS-MID"
}
],
"routeOfAdministration" : [
{
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000073345",
"code" : "100000073633",
"display" : "Subcutaneous use"
},
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000073345",
"code" : "100000073600",
"display" : "Intramuscular use"
},
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000073345",
"code" : "100000073611",
"display" : "Intravenous use"
},
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000073345",
"code" : "100000073572",
"display" : "Epidural use"
}
]
}
}
]
}
},
{
"resource" : {
"resourceType" : "PackagedProductDefinition",
"id" : "MorphineUni-1mgml-Solution-SE-BS-PPD",
"meta" : {
"versionId" : "1",
"lastUpdated" : "2025-11-26T09:26:35.272+00:00",
"profile" : [
"http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PackagedProductDefinition_MorphineUni-1mgml-Solution-SE-BS-PPD\"> </a><p class=\"res-header-id\"><b>Generated Narrative: PackagedProductDefinition MorphineUni-1mgml-Solution-SE-BS-PPD</b></p><a name=\"MorphineUni-1mgml-Solution-SE-BS-PPD\"> </a><a name=\"hcMorphineUni-1mgml-Solution-SE-BS-PPD\"> </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 09:26:35+0000</p><p style=\"margin-bottom: 0px\">Profile: <code>http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition</code></p></div><p><b>identifier</b>: <code>http://ema.europa.eu/example/pcid</code>/?ngen-9?</p><p><b>packageFor</b>: <a href=\"Bundle-bundle-epi-type2-example-morphine.html#MedicinalProductDefinition_MorphineUni-1mgml-Solution-SE-BS-MPD\">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100001732-00056117,http://ema.europa.eu/fhir/eurdId#10549; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Solution for injection; indication = Morphine Unimedic är indikerat för behandling av svår postoperativ och posttraumatisk smärta och svår opioidkänslig smärta såsom smärta vid cancer.; legalStatusOfSupply = Medicinal product subject to special medical prescription; classification = morphine</a></p><p><b>containedItemQuantity</b>: 10 Ampoule<span style=\"background: LightGoldenRodYellow\"> (Details: 200000000014 code200000002164 = '200000002164')</span></p><p><b>description</b>: </p><div><p>Ampull, 10 x 10 ml</p>\n</div><h3>MarketingStatuses</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Country</b></td><td><b>Status</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000000002 100000000535}\">Kingdom of Sweden</span></td><td><span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000072052 100000072083}\">Marketed</span></td></tr></table><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000073346 100000073498}\">Box</span></p><p><b>quantity</b>: 1</p><p><b>material</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/200000003199 200000003529}\">Cardboard</span></p><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000073346 100000073490}\">Ampoule</span></p><p><b>quantity</b>: 10</p><p><b>material</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/200000003199 200000003203}\">Glass</span></p><blockquote><p><b>containedItem</b></p><h3>Items</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-morphine.html#ManufacturedItemDefinition_MorphineUni-1mgml-Solution-SE-BS-MID\">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Solution for injection; unitOfPresentation = Ampoule</a></td></tr></table><p><b>amount</b>: 10 millilitre(s)<span style=\"background: LightGoldenRodYellow\"> (Details: 100000110633~200000000014 code100000110662 = '100000110662')</span></p></blockquote></blockquote></blockquote></div>"
},
"identifier" : [
{
"system" : "http://ema.europa.eu/example/pcid"
}
],
"packageFor" : [
{
"reference" : "MedicinalProductDefinition/MorphineUni-1mgml-Solution-SE-BS-MPD"
}
],
"containedItemQuantity" : [
{
"value" : 10,
"unit" : "Ampoule",
"system" : "http://spor.ema.europa.eu/v1/lists/200000000014",
"code" : "200000002164"
}
],
"description" : "Ampull, 10 x 10 ml",
"marketingStatus" : [
{
"country" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000000002",
"code" : "100000000535",
"display" : "Kingdom of Sweden"
}
]
},
"status" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000072052",
"code" : "100000072083",
"display" : "Marketed"
}
]
}
}
],
"packaging" : {
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000073346",
"code" : "100000073498",
"display" : "Box"
}
]
},
"quantity" : 1,
"material" : [
{
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/200000003199",
"code" : "200000003529",
"display" : "Cardboard"
}
]
}
],
"packaging" : [
{
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000073346",
"code" : "100000073490",
"display" : "Ampoule"
}
]
},
"quantity" : 10,
"material" : [
{
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/200000003199",
"code" : "200000003203",
"display" : "Glass"
}
]
}
],
"containedItem" : [
{
"item" : {
"reference" : {
"reference" : "ManufacturedItemDefinition/MorphineUni-1mgml-Solution-SE-BS-MID"
}
},
"amount" : {
"value" : 10,
"unit" : "millilitre(s)",
"system" : "http://spor.ema.europa.eu/v1/lists/100000110633~200000000014",
"code" : "100000110662"
}
}
]
}
]
}
}
},
{
"resource" : {
"resourceType" : "Ingredient",
"id" : "MorphineUni-1mgml-Solution-SE-BS-ING",
"meta" : {
"versionId" : "1",
"lastUpdated" : "2025-11-26T09:26:27.892+00:00",
"profile" : [
"http://unicom-project.eu/fhir/StructureDefinition/PPLIngredient"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_MorphineUni-1mgml-Solution-SE-BS-ING\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient MorphineUni-1mgml-Solution-SE-BS-ING</b></p><a name=\"MorphineUni-1mgml-Solution-SE-BS-ING\"> </a><a name=\"hcMorphineUni-1mgml-Solution-SE-BS-ING\"> </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 09:26:27+0000</p><p style=\"margin-bottom: 0px\">Profile: <code>http://unicom-project.eu/fhir/StructureDefinition/PPLIngredient</code></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"Bundle-bundle-epi-type2-example-morphine.html#MedicinalProductDefinition_MorphineUni-1mgml-Solution-SE-BS-MPD\">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100001732-00056117,http://ema.europa.eu/fhir/eurdId#10549; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Solution for injection; indication = Morphine Unimedic är indikerat för behandling av svår postoperativ och posttraumatisk smärta och svår opioidkänslig smärta såsom smärta vid cancer.; legalStatusOfSupply = Medicinal product subject to special medical prescription; classification = morphine</a></li><li><a href=\"Bundle-bundle-epi-type2-example-morphine.html#ManufacturedItemDefinition_MorphineUni-1mgml-Solution-SE-BS-MID\">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Solution for injection; unitOfPresentation = Ampoule</a></li><li><a href=\"Bundle-bundle-epi-type2-example-morphine.html#AdministrableProductDefinition_MorphineUni-1mgml-Solution-SE-BS-APD\">AdministrableProductDefinition: status = active; administrableDoseForm = Solution for injection</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>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://spor.azure-api.net/sms/api/v2/SubstanceDefinition 100000090494}\">Morphine hydrochloride</span></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 1 milligram(s)<span style=\"background: LightGoldenRodYellow\"> (Details: 100000110633 code100000110655 = '100000110655')</span>/1 millilitre(s)<span style=\"background: LightGoldenRodYellow\"> (Details: 100000110633 code100000110662 = '100000110662')</span></p><blockquote><p><b>referenceStrength</b></p><h3>Substances</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://spor.azure-api.net/sms/api/v2/SubstanceDefinition 100000091372}\">Morphine</span></td></tr></table><p><b>strength</b>: 0.76 milligram(s)<span style=\"background: LightGoldenRodYellow\"> (Details: 100000110633 code100000110655 = '100000110655')</span>/1 millilitre(s)<span style=\"background: LightGoldenRodYellow\"> (Details: 100000110633 code100000110662 = '100000110662')</span></p></blockquote></blockquote></blockquote></div>"
},
"status" : "active",
"for" : [
{
"reference" : "MedicinalProductDefinition/MorphineUni-1mgml-Solution-SE-BS-MPD"
},
{
"reference" : "ManufacturedItemDefinition/MorphineUni-1mgml-Solution-SE-BS-MID"
},
{
"reference" : "AdministrableProductDefinition/MorphineUni-1mgml-Solution-SE-BS-APD"
}
],
"role" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000072050",
"code" : "100000072072",
"display" : "Active"
}
]
},
"substance" : {
"code" : {
"concept" : {
"coding" : [
{
"system" : "https://spor.azure-api.net/sms/api/v2/SubstanceDefinition",
"code" : "100000090494",
"display" : "Morphine hydrochloride"
}
]
}
},
"strength" : [
{
"concentrationRatio" : {
"numerator" : {
"value" : 1,
"unit" : "milligram(s)",
"system" : "http://spor.ema.europa.eu/v1/lists/100000110633",
"code" : "100000110655"
},
"denominator" : {
"value" : 1,
"unit" : "millilitre(s)",
"system" : "http://spor.ema.europa.eu/v1/lists/100000110633",
"code" : "100000110662"
}
},
"referenceStrength" : [
{
"substance" : {
"concept" : {
"coding" : [
{
"system" : "https://spor.azure-api.net/sms/api/v2/SubstanceDefinition",
"code" : "100000091372",
"display" : "Morphine"
}
]
}
},
"strengthRatio" : {
"numerator" : {
"value" : 0.76,
"unit" : "milligram(s)",
"system" : "https://spor.ema.europa.eu/v1/lists/100000110633",
"code" : "100000110655"
},
"denominator" : {
"value" : 1,
"unit" : "millilitre(s)",
"system" : "http://spor.ema.europa.eu/v1/lists/100000110633",
"code" : "100000110662"
}
}
}
]
}
]
}
}
},
{
"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"
}
},
{
"resource" : {
"resourceType" : "ManufacturedItemDefinition",
"id" : "MorphineUni-1mgml-Solution-SE-BS-MID",
"meta" : {
"versionId" : "1",
"lastUpdated" : "2025-11-26T09:22:32.799+00:00",
"profile" : [
"http://unicom-project.eu/fhir/StructureDefinition/PPLManufacturedItemDefinition"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ManufacturedItemDefinition_MorphineUni-1mgml-Solution-SE-BS-MID\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ManufacturedItemDefinition MorphineUni-1mgml-Solution-SE-BS-MID</b></p><a name=\"MorphineUni-1mgml-Solution-SE-BS-MID\"> </a><a name=\"hcMorphineUni-1mgml-Solution-SE-BS-MID\"> </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 09:22:32+0000</p><p style=\"margin-bottom: 0px\">Profile: <code>http://unicom-project.eu/fhir/StructureDefinition/PPLManufacturedItemDefinition</code></p></div><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 200000002164}\">Ampoule</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" : "200000002164",
"display" : "Ampoule"
}
]
}
}
}
]
}
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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