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 and Regulation. 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-paracetamol",
"meta" : {
"versionId" : "1.0",
"lastUpdated" : "2023-01-25T12:00:00Z",
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/bundle-epi-type2"
]
},
"language" : "en",
"identifier" : {
"system" : "http://ema.europa.eu/identifier",
"value" : "WONDERDRUG-500MG-BUNDLE"
},
"type" : "document",
"timestamp" : "2023-01-25T12:00:00Z",
"entry" : [
{
"fullUrl" : "http://hl7.org/fhir/uv/emedicinal-product-info/Composition/composition-epi-type2-example-paracetamol",
"resource" : {
"resourceType" : "Composition",
"id" : "composition-epi-type2-example-paracetamol",
"meta" : {
"versionId" : "1",
"lastUpdated" : "2023-01-25T10:00:00Z",
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/composition-epi-type1"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><a name=\"Composition_composition-epi-type2-example-paracetamol\"> </a><p>Package Leaflet: Information for the user - Paracetamol Tablets</p></div>"
},
"contained" : [
{
"resourceType" : "Binary",
"id" : "binaryImage-t2",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/binary-epi"
]
},
"contentType" : "image/png",
"data" : "iVBORw0KGgoAAAANSUhEUgAAAAEAAAABCAQAAAC1HAwCAAAAC0lEQVR42mNkYAAAAAYAAjCB0C8AAAAASUVORK5CYII="
}
],
"identifier" : [
{
"system" : "http://example.org/identifier",
"value" : "composition-epi-type2-example-paracetamol"
}
],
"version" : "1.0",
"status" : "final",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000155538",
"display" : "Package Leaflet"
}
]
},
"subject" : [
{
🔗 "reference" : "http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-epi-type2-example-paracetamol"
}
],
"date" : "2023-01-25",
"author" : [
{
🔗 "reference" : "Organization/org-epi-type2-example-acme"
}
],
"title" : "Package Leaflet: Information for the user - WonderDrug 500 mg tablets",
"section" : [
{
"id" : "root-section",
"title" : "Package Leaflet",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000155538",
"display" : "Package Leaflet"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\">Package Leaflet</div>"
},
"entry" : [
{
🔗 "reference" : "Organization/org-epi-type2-example-acme"
},
{
🔗 "reference" : "MedicinalProductDefinition/mpd-epi-type2-example-paracetamol"
}
],
"section" : [
{
"id" : "section-1",
"title" : "1. What is in this leaflet",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000155538",
"display" : "1. What is in this leaflet"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><h2>1. What is in this leaflet</h2><p>Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.</p></div>"
}
}
]
}
]
}
},
{
"fullUrl" : "http://hl7.org/fhir/uv/emedicinal-product-info/Organization/org-epi-type2-example-acme",
"resource" : {
"resourceType" : "Organization",
"id" : "org-epi-type2-example-acme",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_org-epi-type2-example-acme\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization org-epi-type2-example-acme</b></p><a name=\"org-epi-type2-example-acme\"> </a><a name=\"hcorg-epi-type2-example-acme\"> </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-Organization-uv-epi.html\">Organization (ePI)</a></p></div><p><b>identifier</b>: <code>https://spor.ema.europa.eu/omswi</code>/LOC-100000000</p><p><b>active</b>: true</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 220000000034}\">Marketing authorisation holder</span></p><p><b>name</b>: Acme Pharma Inc.</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>123 Pharma Way, 102 37 Prague 10, Czech Republic</td></tr></table></div>"
},
"identifier" : [
{
"system" : "https://spor.ema.europa.eu/omswi",
"value" : "LOC-100000000"
}
],
"active" : true,
"type" : [
{
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "220000000034",
"display" : "Marketing authorisation holder"
}
]
}
],
"name" : "Acme Pharma Inc.",
"contact" : [
{
"address" : {
"text" : "123 Pharma Way, 102 37 Prague 10, Czech Republic",
"line" : [
"123 Pharma Way"
],
"city" : "Prague",
"postalCode" : "102 37",
"country" : "Czech Republic"
}
}
]
}
},
{
"fullUrl" : "http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-epi-type2-example-paracetamol",
"resource" : {
"resourceType" : "MedicinalProductDefinition",
"id" : "mpd-epi-type2-example-paracetamol",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_mpd-epi-type2-example-paracetamol\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition mpd-epi-type2-example-paracetamol</b></p><a name=\"mpd-epi-type2-example-paracetamol\"> </a><a name=\"hcmpd-epi-type2-example-paracetamol\"> </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-MedicinalProductDefinition-uv-epi.html\">MedicinalProductDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/WONDERDRUG-500MG</p><p><b>domain</b>: <span title=\"Codes:{http://hl7.org/fhir/medicinal-product-domain Human}\">Human use</span></p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">Active</span></p><p><b>legalStatusOfSupply</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000072084}\">Medicinal product subject to medical prescription</span></p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Contact</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Organization-org-epi-type2-example-acme.html\">Organization Acme Pharma Inc.</a></td></tr></table><blockquote><p><b>name</b></p><p><b>productName</b>: WonderDrug 500 mg tablets</p><blockquote><p><b>part</b></p><p><b>part</b>: WonderDrug</p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/medicinal-product-name-part-type InventedNamePart}\">Invented name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 500 mg</p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/medicinal-product-name-part-type StrengthPart}\">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: tablets</p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/medicinal-product-name-part-type DoseFormPart}\">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:{urn:iso:std:iso:3166 EE}\">Estonia</span></td><td><span title=\"Codes:{urn:ietf:bcp:47 et}\">Estonian</span></td></tr></table></blockquote></div>"
},
"identifier" : [
{
"system" : "http://ema.europa.eu/identifier",
"value" : "WONDERDRUG-500MG"
}
],
"domain" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/medicinal-product-domain",
"code" : "Human",
"display" : "Human use"
}
]
},
"status" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/publication-status",
"code" : "active",
"display" : "Active"
}
]
},
"legalStatusOfSupply" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000072084",
"display" : "Medicinal product subject to medical prescription"
}
]
},
"contact" : [
{
"contact" : {
🔗 "reference" : "Organization/org-epi-type2-example-acme"
}
}
],
"name" : [
{
"productName" : "WonderDrug 500 mg tablets",
"part" : [
{
"part" : "WonderDrug",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/medicinal-product-name-part-type",
"code" : "InventedNamePart",
"display" : "Invented name part"
}
]
}
},
{
"part" : "500 mg",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/medicinal-product-name-part-type",
"code" : "StrengthPart",
"display" : "Strength part"
}
]
}
},
{
"part" : "tablets",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/medicinal-product-name-part-type",
"code" : "DoseFormPart",
"display" : "Pharmaceutical dose form part"
}
]
}
}
],
"usage" : [
{
"country" : {
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "EE",
"display" : "Estonia"
}
]
},
"language" : {
"coding" : [
{
"system" : "urn:ietf:bcp:47",
"code" : "et",
"display" : "Estonian"
}
]
}
}
]
}
]
}
},
{
"fullUrl" : "http://hl7.org/fhir/uv/emedicinal-product-info/RegulatedAuthorization/ra-epi-type2-example-paracetamol",
"resource" : {
"resourceType" : "RegulatedAuthorization",
"id" : "ra-epi-type2-example-paracetamol",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/RegulatedAuthorization-uv-epi"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"RegulatedAuthorization_ra-epi-type2-example-paracetamol\"> </a><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization ra-epi-type2-example-paracetamol</b></p><a name=\"ra-epi-type2-example-paracetamol\"> </a><a name=\"hcra-epi-type2-example-paracetamol\"> </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-RegulatedAuthorization-uv-epi.html\">RegulatedAuthorization (ePI)</a></p></div><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/MA-123456789</p><p><b>subject</b>: <a href=\"Bundle-bundle-epi-type2-example-paracetamol.html#http-//hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-epi-type2-example-paracetamol\">MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active; legalStatusOfSupply = Medicinal product subject to medical prescription</a></p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 220000000061}\">Marketing Authorisation</span></p><p><b>region</b>: <span title=\"Codes:{urn:iso:std:iso:3166 EE}\">Estonia</span></p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">Active</span></p><p><b>holder</b>: <a href=\"Organization-org-epi-type2-example-acme.html\">Organization Acme Pharma Inc.</a></p></div>"
},
"identifier" : [
{
"system" : "http://ema.europa.eu/identifier",
"value" : "MA-123456789"
}
],
"subject" : [
{
🔗 "reference" : "http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-epi-type2-example-paracetamol"
}
],
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "220000000061",
"display" : "Marketing Authorisation"
}
]
},
"region" : [
{
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "EE",
"display" : "Estonia"
}
]
}
],
"status" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/publication-status",
"code" : "active",
"display" : "Active"
}
]
},
"holder" : {
🔗 "reference" : "Organization/org-epi-type2-example-acme"
}
}
},
{
"fullUrl" : "http://hl7.org/fhir/uv/emedicinal-product-info/PackagedProductDefinition/ppd-epi-type2-example-paracetamol",
"resource" : {
"resourceType" : "PackagedProductDefinition",
"id" : "ppd-epi-type2-example-paracetamol",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PackagedProductDefinition_ppd-epi-type2-example-paracetamol\"> </a><p class=\"res-header-id\"><b>Generated Narrative: PackagedProductDefinition ppd-epi-type2-example-paracetamol</b></p><a name=\"ppd-epi-type2-example-paracetamol\"> </a><a name=\"hcppd-epi-type2-example-paracetamol\"> </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-PackagedProductDefinition-uv-epi.html\">PackagedProductDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>http://example.org/identifier</code>/ppd-epi-type2-example-paracetamol</p><p><b>packageFor</b>: <a href=\"MedicinalProductDefinition-mpd-epi-type2-example-paracetamol.html\">MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active; legalStatusOfSupply = Medicinal product subject to medical prescription</a></p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">Active</span></p><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000073498}\">Box</span></p><p><b>quantity</b>: 1</p><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000073496}\">Blister</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=\"ManufacturedItemDefinition-mid-epi-type2-example-paracetamol.html\">ManufacturedItemDefinition: identifier = http://example.org/identifier#mid-epi-type2-example-paracetamol; status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet</a></td></tr></table><p><b>amount</b>: 30 Tablet</p></blockquote></blockquote></blockquote></div>"
},
"identifier" : [
{
"system" : "http://example.org/identifier",
"value" : "ppd-epi-type2-example-paracetamol"
}
],
"packageFor" : [
{
🔗 "reference" : "MedicinalProductDefinition/mpd-epi-type2-example-paracetamol"
}
],
"status" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/publication-status",
"code" : "active",
"display" : "Active"
}
]
},
"packaging" : {
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000073498",
"display" : "Box"
}
]
},
"quantity" : 1,
"packaging" : [
{
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000073496",
"display" : "Blister"
}
]
},
"containedItem" : [
{
"item" : {
"reference" : {
🔗 "reference" : "ManufacturedItemDefinition/mid-epi-type2-example-paracetamol"
}
},
"amount" : {
"value" : 30,
"unit" : "Tablet",
"system" : "http://standardterms.edqm.eu"
}
}
]
}
]
}
}
},
{
"fullUrl" : "http://hl7.org/fhir/uv/emedicinal-product-info/ManufacturedItemDefinition/mid-epi-type2-example-paracetamol",
"resource" : {
"resourceType" : "ManufacturedItemDefinition",
"id" : "mid-epi-type2-example-paracetamol",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ManufacturedItemDefinition-uv-epi"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ManufacturedItemDefinition_mid-epi-type2-example-paracetamol\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ManufacturedItemDefinition mid-epi-type2-example-paracetamol</b></p><a name=\"mid-epi-type2-example-paracetamol\"> </a><a name=\"hcmid-epi-type2-example-paracetamol\"> </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-ManufacturedItemDefinition-uv-epi.html\">ManufacturedItemDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>http://example.org/identifier</code>/mid-epi-type2-example-paracetamol</p><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000073664}\">Tablet</span></p><p><b>unitOfPresentation</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 200000002152}\">Tablet</span></p><blockquote><p><b>property</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig shape}\">Shape</span></p><p><b>value</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000073670}\">Round</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig color}\">Color</span></p><p><b>value</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000073586}\">White</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig size}\">Size</span></p><p><b>value</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000000000}\">10 mm</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig score}\">Score</span></p><p><b>value</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000000000}\">Scored</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig imprint}\">Imprint</span></p><p><b>value</b>: </p><div><p>WD500</p>\n</div></blockquote></div>"
},
"identifier" : [
{
"system" : "http://example.org/identifier",
"value" : "mid-epi-type2-example-paracetamol"
}
],
"status" : "active",
"manufacturedDoseForm" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000073664",
"display" : "Tablet"
}
]
},
"unitOfPresentation" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000002152",
"display" : "Tablet"
}
]
},
"property" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig",
"code" : "shape",
"display" : "Shape"
}
]
},
"valueCodeableConcept" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000073670",
"display" : "Round"
}
]
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig",
"code" : "color",
"display" : "Color"
}
]
},
"valueCodeableConcept" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000073586",
"display" : "White"
}
]
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig",
"code" : "size",
"display" : "Size"
}
]
},
"valueCodeableConcept" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000000000",
"display" : "10 mm"
}
]
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig",
"code" : "score",
"display" : "Score"
}
]
},
"valueCodeableConcept" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000000000",
"display" : "Scored"
}
]
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig",
"code" : "imprint",
"display" : "Imprint"
}
]
},
"valueMarkdown" : "WD500"
}
]
}
},
{
"fullUrl" : "http://hl7.org/fhir/uv/emedicinal-product-info/AdministrableProductDefinition/apd-epi-type2-example-paracetamol",
"resource" : {
"resourceType" : "AdministrableProductDefinition",
"id" : "apd-epi-type2-example-paracetamol",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/AdministrableProductDefinition-uv-epi"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"AdministrableProductDefinition_apd-epi-type2-example-paracetamol\"> </a><p class=\"res-header-id\"><b>Generated Narrative: AdministrableProductDefinition apd-epi-type2-example-paracetamol</b></p><a name=\"apd-epi-type2-example-paracetamol\"> </a><a name=\"hcapd-epi-type2-example-paracetamol\"> </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-AdministrableProductDefinition-uv-epi.html\">AdministrableProductDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>http://example.org/identifier</code>/apd-epi-type2-example-paracetamol</p><p><b>status</b>: Active</p><p><b>formOf</b>: <a href=\"MedicinalProductDefinition-mpd-epi-type2-example-paracetamol.html\">MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active; legalStatusOfSupply = Medicinal product subject to medical prescription</a></p><p><b>administrableDoseForm</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000073664}\">Tablet</span></p><p><b>unitOfPresentation</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 200000002152}\">Tablet</span></p><p><b>producedFrom</b>: <a href=\"ManufacturedItemDefinition-mid-epi-type2-example-paracetamol.html\">ManufacturedItemDefinition: identifier = http://example.org/identifier#mid-epi-type2-example-paracetamol; status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet</a></p><blockquote><p><b>property</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig shape}\">Shape</span></p><p><b>value</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000073670}\">Round</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig color}\">Color</span></p><p><b>value</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000073586}\">White</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig flavor}\">Flavor</span></p><p><b>value</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000000000}\">None</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig image}\">Image</span></p><p><b>value</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000000000}\">Tablet Image</span></p></blockquote><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/rmswi 100000073619}\">Oral use</span></td></tr></table></div>"
},
"identifier" : [
{
"system" : "http://example.org/identifier",
"value" : "apd-epi-type2-example-paracetamol"
}
],
"status" : "active",
"formOf" : [
{
🔗 "reference" : "MedicinalProductDefinition/mpd-epi-type2-example-paracetamol"
}
],
"administrableDoseForm" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000073664",
"display" : "Tablet"
}
]
},
"unitOfPresentation" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000002152",
"display" : "Tablet"
}
]
},
"producedFrom" : [
{
🔗 "reference" : "ManufacturedItemDefinition/mid-epi-type2-example-paracetamol"
}
],
"property" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig",
"code" : "shape",
"display" : "Shape"
}
]
},
"valueCodeableConcept" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000073670",
"display" : "Round"
}
]
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig",
"code" : "color",
"display" : "Color"
}
]
},
"valueCodeableConcept" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000073586",
"display" : "White"
}
]
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig",
"code" : "flavor",
"display" : "Flavor"
}
]
},
"valueCodeableConcept" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000000000",
"display" : "None"
}
]
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig",
"code" : "image",
"display" : "Image"
}
]
},
"valueCodeableConcept" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000000000",
"display" : "Tablet Image"
}
]
}
}
],
"routeOfAdministration" : [
{
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000073619",
"display" : "Oral use"
}
]
}
}
]
}
},
{
"fullUrl" : "http://hl7.org/fhir/uv/emedicinal-product-info/Ingredient/ingredient-epi-type2-example-paracetamol-active",
"resource" : {
"resourceType" : "Ingredient",
"id" : "ingredient-epi-type2-example-paracetamol-active",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_ingredient-epi-type2-example-paracetamol-active\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient ingredient-epi-type2-example-paracetamol-active</b></p><a name=\"ingredient-epi-type2-example-paracetamol-active\"> </a><a name=\"hcingredient-epi-type2-example-paracetamol-active\"> </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-Ingredient-uv-epi.html\">Ingredient (ePI)</a></p></div><p><b>identifier</b>: <code>http://example.org/identifier</code>/ingredient-epi-type2-example-paracetamol-active</p><p><b>status</b>: Active</p><p><b>for</b>: <a href=\"ManufacturedItemDefinition-mid-epi-type2-example-paracetamol.html\">ManufacturedItemDefinition: identifier = http://example.org/identifier#mid-epi-type2-example-paracetamol; status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet</a></p><p><b>role</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000072072}\">Active</span></p><p><b>function</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000136065}\">API</span></p><p><b>group</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000136179}\">Chemical</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.ema.europa.eu/smswi 100000000000}\">Paracetamol</span></td></tr></table><h3>Strengths</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Presentation[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>500 mg<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codemg = 'mg')</span>/1 tablet<span style=\"background: LightGoldenRodYellow\"> (Details: EDQM Standard Terms code10219000 = 'Tablet')</span></td></tr></table></blockquote></div>"
},
"identifier" : {
"system" : "http://example.org/identifier",
"value" : "ingredient-epi-type2-example-paracetamol-active"
},
"status" : "active",
"for" : [
{
🔗 "reference" : "ManufacturedItemDefinition/mid-epi-type2-example-paracetamol"
}
],
"role" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000072072",
"display" : "Active"
}
]
},
"function" : [
{
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000136065",
"display" : "API"
}
]
}
],
"group" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000136179",
"display" : "Chemical"
}
]
},
"substance" : {
"code" : {
"concept" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/smswi",
"code" : "100000000000",
"display" : "Paracetamol"
}
]
}
},
"strength" : [
{
"presentationRatio" : {
"numerator" : {
"value" : 500,
"unit" : "mg",
"system" : "http://unitsofmeasure.org",
"code" : "mg"
},
"denominator" : {
"value" : 1,
"unit" : "tablet",
"system" : "http://standardterms.edqm.eu",
"code" : "10219000"
}
}
}
]
}
}
},
{
"fullUrl" : "http://hl7.org/fhir/uv/emedicinal-product-info/Ingredient/ingredient-epi-type2-example-paracetamol-excipient-1",
"resource" : {
"resourceType" : "Ingredient",
"id" : "ingredient-epi-type2-example-paracetamol-excipient-1",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_ingredient-epi-type2-example-paracetamol-excipient-1\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient ingredient-epi-type2-example-paracetamol-excipient-1</b></p><a name=\"ingredient-epi-type2-example-paracetamol-excipient-1\"> </a><a name=\"hcingredient-epi-type2-example-paracetamol-excipient-1\"> </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-Ingredient-uv-epi.html\">Ingredient (ePI)</a></p></div><p><b>identifier</b>: <code>http://example.org/identifier</code>/ingredient-epi-type2-example-paracetamol-excipient-1</p><p><b>status</b>: Active</p><p><b>for</b>: <a href=\"ManufacturedItemDefinition-mid-epi-type2-example-paracetamol.html\">ManufacturedItemDefinition: identifier = http://example.org/identifier#mid-epi-type2-example-paracetamol; status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet</a></p><p><b>role</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000072082}\">Excipient</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.ema.europa.eu/smswi 100000000001}\">Pregelatinised starch</span></td></tr></table></blockquote></div>"
},
"identifier" : {
"system" : "http://example.org/identifier",
"value" : "ingredient-epi-type2-example-paracetamol-excipient-1"
},
"status" : "active",
"for" : [
{
🔗 "reference" : "ManufacturedItemDefinition/mid-epi-type2-example-paracetamol"
}
],
"role" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000072082",
"display" : "Excipient"
}
]
},
"substance" : {
"code" : {
"concept" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/smswi",
"code" : "100000000001",
"display" : "Pregelatinised starch"
}
]
}
}
}
}
},
{
"fullUrl" : "http://hl7.org/fhir/uv/emedicinal-product-info/Ingredient/ingredient-epi-type2-example-paracetamol-excipient-2",
"resource" : {
"resourceType" : "Ingredient",
"id" : "ingredient-epi-type2-example-paracetamol-excipient-2",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_ingredient-epi-type2-example-paracetamol-excipient-2\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient ingredient-epi-type2-example-paracetamol-excipient-2</b></p><a name=\"ingredient-epi-type2-example-paracetamol-excipient-2\"> </a><a name=\"hcingredient-epi-type2-example-paracetamol-excipient-2\"> </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-Ingredient-uv-epi.html\">Ingredient (ePI)</a></p></div><p><b>identifier</b>: <code>http://example.org/identifier</code>/ingredient-epi-type2-example-paracetamol-excipient-2</p><p><b>status</b>: Active</p><p><b>for</b>: <a href=\"ManufacturedItemDefinition-mid-epi-type2-example-paracetamol.html\">ManufacturedItemDefinition: identifier = http://example.org/identifier#mid-epi-type2-example-paracetamol; status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet</a></p><p><b>role</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000072082}\">Excipient</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.ema.europa.eu/smswi 100000000002}\">Maize starch</span></td></tr></table></blockquote></div>"
},
"identifier" : {
"system" : "http://example.org/identifier",
"value" : "ingredient-epi-type2-example-paracetamol-excipient-2"
},
"status" : "active",
"for" : [
{
🔗 "reference" : "ManufacturedItemDefinition/mid-epi-type2-example-paracetamol"
}
],
"role" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000072082",
"display" : "Excipient"
}
]
},
"substance" : {
"code" : {
"concept" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/smswi",
"code" : "100000000002",
"display" : "Maize starch"
}
]
}
}
}
}
},
{
"fullUrl" : "http://hl7.org/fhir/uv/emedicinal-product-info/Ingredient/ingredient-epi-type2-example-paracetamol-excipient-3",
"resource" : {
"resourceType" : "Ingredient",
"id" : "ingredient-epi-type2-example-paracetamol-excipient-3",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_ingredient-epi-type2-example-paracetamol-excipient-3\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient ingredient-epi-type2-example-paracetamol-excipient-3</b></p><a name=\"ingredient-epi-type2-example-paracetamol-excipient-3\"> </a><a name=\"hcingredient-epi-type2-example-paracetamol-excipient-3\"> </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-Ingredient-uv-epi.html\">Ingredient (ePI)</a></p></div><p><b>identifier</b>: <code>http://example.org/identifier</code>/ingredient-epi-type2-example-paracetamol-excipient-3</p><p><b>status</b>: Active</p><p><b>for</b>: <a href=\"ManufacturedItemDefinition-mid-epi-type2-example-paracetamol.html\">ManufacturedItemDefinition: identifier = http://example.org/identifier#mid-epi-type2-example-paracetamol; status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet</a></p><p><b>role</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000072082}\">Excipient</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.ema.europa.eu/smswi 100000000003}\">Magnesium stearate</span></td></tr></table></blockquote></div>"
},
"identifier" : {
"system" : "http://example.org/identifier",
"value" : "ingredient-epi-type2-example-paracetamol-excipient-3"
},
"status" : "active",
"for" : [
{
🔗 "reference" : "ManufacturedItemDefinition/mid-epi-type2-example-paracetamol"
}
],
"role" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000072082",
"display" : "Excipient"
}
]
},
"substance" : {
"code" : {
"concept" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/smswi",
"code" : "100000000003",
"display" : "Magnesium stearate"
}
]
}
}
}
}
}
]
}
IG © 2022+ HL7 International / Biomedical Research and Regulation.
Package hl7.fhir.uv.emedicinal-product-info#1.1.0 based on FHIR 5.0.0.
Generated
2026-04-03
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