Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0 - trial-use
Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0 - trial-use
This page is part of the Electronic Medicinal Product Information (ePI) FHIR Implementation Guide (v1.0.0: STU1) based on FHIR v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions 
{
"resourceType" : "Bundle",
"id" : "bundlepackageleaflet75type3",
"meta" : {
"versionId" : "1",
"lastUpdated" : "2018-06-23T08:38:00+02:00",
"profile" : [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi"
]
},
"language" : "en",
"identifier" : {
"system" : "https://www.gravitatehealth.eu/sid/doc",
"value" : "EU/3/03/003/003"
},
"type" : "document",
"timestamp" : "2018-06-23T08:38:00+02:00",
"entry" : [
{
"fullUrl" : "urn:uuid:fe63fd6a-afe8-4b61-a203-0cf4a69ffb60",
"resource" : {
"resourceType" : "Composition",
"id" : "fe63fd6a-afe8-4b61-a203-0cf4a69ffb60",
"meta" : {
"profile" : [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"en\" lang=\"en\"><p><b>Generated Narrative: Composition</b><a name=\"fe63fd6a-afe8-4b61-a203-0cf4a69ffb60\"> </a></p><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\">Resource Composition "fe63fd6a-afe8-4b61-a203-0cf4a69ffb60" (Language "en") </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-Composition-uv-epi.html\">Composition (ePI)</a></p></div><p><b>identifier</b>: id:\u00a00d69fdcb-33cf-407f-8209-a6529856ab4f</p><p><b>status</b>: final</p><p><b>type</b>: Package Leaflet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (example.org#100000155538)</span></p><p><b>date</b>: 2022-02-16 13:28:17+0000</p><p><b>author</b>: <a href=\"#Organization_d71bf884-90eb-47f9-81b7-fa81ecec7e75\">See above (Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75)</a></p><p><b>title</b>: Example of Type 3 ePI - DrugX (acetaminophen) 75 mg tablets</p></div>"
},
"identifier" : [
{
"system" : "https://spor.ema.europa.eu",
"value" : "0d69fdcb-33cf-407f-8209-a6529856ab4f"
}
],
"status" : "final",
"type" : {
"coding" : [
{
"system" : "http://example.org",
"code" : "100000155538",
"display" : "Package Leaflet"
}
]
},
"subject" : [
{
"reference" : "MedicinalProductDefinition/800a51a2-d81d-49a4-a4eb-f2417d301837"
}
],
"date" : "2022-02-16T13:28:17Z",
"author" : [
{
"reference" : "Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75"
}
],
"title" : "Example of Type 3 ePI - DrugX (acetaminophen) 75 mg tablets",
"section" : [
{
"title" : "B. Package Leaflet",
"code" : {
"coding" : [
{
"system" : "http://example.org",
"code" : "200000029894",
"display" : "PACKAGE LEAFLET"
}
]
},
"section" : [
{
"title" : "Package leaflet: Information for the user",
"code" : {
"text" : "Package leaflet: Information for the user"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>DrugX 75 mg tablets</p><p>acetaminophen</p><b>Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.</b><ul><li>Keep this leaflet. You may need to read it again.</li><li>If you have any further questions, ask your doctor or pharmacist.</li><li>This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.</li><li>If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.</li></ul></div>"
}
},
{
"title" : "What is in this leaflet",
"code" : {
"text" : "What is in this leaflet"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><ul><li>What DrugX is and what it is used for</li><li>What you need to know before you take DrugX</li><li>How to take DrugX</li><li>Possible side effects</li><li>How to store DrugX</li><li>Contents of the pack and other information</li></ul></div>"
}
},
{
"title" : "1. What DrugX is and what it is used for",
"code" : {
"coding" : [
{
"system" : "http://example.org",
"code" : "200000029895",
"display" : "1. What X is and what it is used for"
}
]
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.</p></div>"
}
},
{
"title" : "2. What you need to know before you take DrugX",
"code" : {
"coding" : [
{
"system" : "http://example.org",
"code" : "200000029896",
"display" : "2. What you need to know before you <take> <use> X"
}
]
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.</p></div>"
}
},
{
"title" : "3. How to take DrugX",
"code" : {
"coding" : [
{
"system" : "http://example.org",
"code" : "200000029905",
"display" : "3. How to <take> <use> X"
}
]
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.</p></div>"
}
},
{
"title" : "4. Possible side effects",
"code" : {
"coding" : [
{
"system" : "http://example.org",
"code" : "200000029910",
"display" : "4. Possible side effects"
}
],
"text" : "4. Possible side effects"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.</p></div>"
}
},
{
"title" : "5. How to store DrugX",
"code" : {
"coding" : [
{
"system" : "http://example.org",
"code" : "200000029913",
"display" : "5. How to store X"
}
]
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.</p></div>"
}
},
{
"title" : "6. Contents of the pack and other information",
"code" : {
"coding" : [
{
"system" : "http://example.org",
"code" : "200000029914",
"display" : "6. Contents of the pack and other information"
}
]
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.</p></div>"
}
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:d71bf884-90eb-47f9-81b7-fa81ecec7e75",
"resource" : {
"resourceType" : "Organization",
"id" : "d71bf884-90eb-47f9-81b7-fa81ecec7e75",
"meta" : {
"profile" : [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Organization</b><a name=\"d71bf884-90eb-47f9-81b7-fa81ecec7e75\"> </a></p><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\">Resource Organization "d71bf884-90eb-47f9-81b7-fa81ecec7e75" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-Organization-uv-epi.html\">Organization (ePI)</a></p></div><p><b>identifier</b>: id:\u00a0ORG1\u00a0(use:\u00a0OFFICIAL)</p><p><b>active</b>: true</p><p><b>type</b>: Marketing authorisation holder <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (example.org#220000000034)</span></p><p><b>name</b>: acme 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>54, Yonge Street, Paris, France(WORK)</td></tr></table></div>"
},
"identifier" : [
{
"use" : "official",
"system" : "http://example.org/sid/org",
"value" : "ORG1"
}
],
"active" : true,
"type" : [
{
"coding" : [
{
"system" : "http://example.org",
"code" : "220000000034",
"display" : "Marketing authorisation holder"
}
]
}
],
"name" : "acme inc",
"contact" : [
{
"address" : {
"use" : "work",
"type" : "physical",
"text" : "54, Yonge Street, Paris, France",
"line" : [
"54, Yonge Street"
],
"city" : "Paris",
"country" : "FR"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:297e405a-b6f9-4273-bc01-ae031efe47f8",
"resource" : {
"resourceType" : "RegulatedAuthorization",
"id" : "297e405a-b6f9-4273-bc01-ae031efe47f8",
"meta" : {
"profile" : [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/RegulatedAuthorization-uv-epi"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: RegulatedAuthorization</b><a name=\"297e405a-b6f9-4273-bc01-ae031efe47f8\"> </a></p><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\">Resource RegulatedAuthorization "297e405a-b6f9-4273-bc01-ae031efe47f8" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-RegulatedAuthorization-uv-epi.html\">RegulatedAuthorization (ePI)</a></p></div><p><b>identifier</b>: id:\u00a0authorization75mg\u00a0(use:\u00a0OFFICIAL)</p><p><b>subject</b>: <a href=\"#MedicinalProductDefinition_800a51a2-d81d-49a4-a4eb-f2417d301837\">See above (MedicinalProductDefinition/800a51a2-d81d-49a4-a4eb-f2417d301837)</a></p><p><b>type</b>: Marketing Authorization <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-regulated-authorization-type.html\">Regulated Authorization Type</a>#MarketingAuth)</span></p><p><b>region</b>: European Union <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-ISO3166Part1.html\">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#FR)</span></p><p><b>status</b>: Active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-publication-status.html\">PublicationStatus</a>#active)</span></p><p><b>statusDate</b>: 2015-02-07 13:28:17+0000</p><p><b>holder</b>: <a href=\"#Organization_d71bf884-90eb-47f9-81b7-fa81ecec7e75\">See above (Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75)</a></p></div>"
},
"identifier" : [
{
"use" : "official",
"system" : "http://example.org/sid/product",
"value" : "authorization75mg"
}
],
"subject" : [
{
"reference" : "MedicinalProductDefinition/800a51a2-d81d-49a4-a4eb-f2417d301837"
}
],
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/regulated-authorization-type",
"code" : "MarketingAuth",
"display" : "Marketing Authorization"
}
]
},
"region" : [
{
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "FR"
}
],
"text" : "European Union"
}
],
"status" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/publication-status",
"code" : "active",
"display" : "Active"
}
]
},
"statusDate" : "2015-02-07T13:28:17Z",
"holder" : {
"reference" : "Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75"
}
}
},
{
"fullUrl" : "urn:uuid:800a51a2-d81d-49a4-a4eb-f2417d301837",
"resource" : {
"resourceType" : "MedicinalProductDefinition",
"id" : "800a51a2-d81d-49a4-a4eb-f2417d301837",
"meta" : {
"profile" : [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: MedicinalProductDefinition</b><a name=\"800a51a2-d81d-49a4-a4eb-f2417d301837\"> </a></p><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\">Resource MedicinalProductDefinition "800a51a2-d81d-49a4-a4eb-f2417d301837" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-MedicinalProductDefinition-uv-epi.html\">MedicinalProductDefinition (ePI)</a></p></div><p><b>identifier</b>: id:\u00a0medicinalproduct75</p><p><b>type</b>: Medicinal Product <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-medicinal-product-type.html\">Medicinal Product Type</a>#MedicinalProduct)</span></p><p><b>domain</b>: Human use <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-medicinal-product-domain.html\">Medicinal Product Domain</a>#Human)</span></p><p><b>status</b>: Active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-publication-status.html\">PublicationStatus</a>#active)</span></p><p><b>statusDate</b>: 2018-06-23 08:38:00+0200</p><p><b>legalStatusOfSupply</b>: Medicinal product subject to medical prescription <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-legal-status-of-supply.html\">Legal Status Of Supply</a>#100000072084)</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: DrugX</p><h3>Parts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Part</b></td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td>tablet</td><td>Invented name part <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (example.org#220000000005 "Administrable dose form part")</span></td></tr></table><h3>Usages</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Country</b></td><td><b>Jurisdiction</b></td><td><b>Language</b></td></tr><tr><td style=\"display: none\">*</td><td>France <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-ISO3166Part1.html\">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#FR)</span></td><td>France <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-ISO3166Part1.html\">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#FR)</span></td><td>English <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v3-ietf3066.html\">Tags for the Identification of Languages</a>#en)</span></td></tr></table></blockquote></div>"
},
"identifier" : [
{
"system" : "http://example.org/sid/product",
"value" : "medicinalproduct75"
}
],
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/medicinal-product-type",
"code" : "MedicinalProduct",
"display" : "Medicinal Product"
}
]
},
"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"
}
]
},
"statusDate" : "2018-06-23T08:38:00+02:00",
"legalStatusOfSupply" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/legal-status-of-supply",
"code" : "100000072084",
"display" : "Medicinal product subject to medical prescription"
}
]
},
"name" : [
{
"productName" : "DrugX",
"part" : [
{
"part" : "tablet",
"type" : {
"coding" : [
{
"system" : "http://example.org",
"code" : "220000000005",
"display" : "Administrable dose form part"
}
],
"text" : "Invented name part"
}
}
],
"usage" : [
{
"country" : {
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "FR"
}
]
},
"jurisdiction" : {
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "FR"
}
]
},
"language" : {
"coding" : [
{
"system" : "urn:ietf:bcp:47",
"code" : "en"
}
]
}
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:eb8392a6-2cec-4ff3-9d9e-7c5f4ae3786d",
"resource" : {
"resourceType" : "PackagedProductDefinition",
"id" : "eb8392a6-2cec-4ff3-9d9e-7c5f4ae3786d",
"meta" : {
"profile" : [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: PackagedProductDefinition</b><a name=\"eb8392a6-2cec-4ff3-9d9e-7c5f4ae3786d\"> </a></p><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\">Resource PackagedProductDefinition "eb8392a6-2cec-4ff3-9d9e-7c5f4ae3786d" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-PackagedProductDefinition-uv-epi.html\">PackagedProductDefinition (ePI)</a></p></div><p><b>identifier</b>: id:\u00a0EU/1/97/049/001\u00a0(use:\u00a0OFFICIAL)</p><p><b>name</b>: DrugX 75 mg tablet blister x28 tablets</p><p><b>type</b>: Medicinal Product <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-medicinal-product-type.html\">Medicinal Product Type</a>#MedicinalProduct)</span></p><p><b>packageFor</b>: <a href=\"#MedicinalProductDefinition_800a51a2-d81d-49a4-a4eb-f2417d301837\">See above (MedicinalProductDefinition/800a51a2-d81d-49a4-a4eb-f2417d301837)</a></p><p><b>status</b>: Active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-publication-status.html\">PublicationStatus</a>#active)</span></p><p><b>statusDate</b>: 2018-06-23 08:38:00+0200</p><p><b>containedItemQuantity</b>: 75 mg</p><p><b>manufacturer</b>: <a href=\"#Organization_d71bf884-90eb-47f9-81b7-fa81ecec7e75\">See above (Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75)</a></p><h3>Packagings</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Identifier</b></td><td><b>Type</b></td><td><b>Quantity</b></td><td><b>Material</b></td></tr><tr><td style=\"display: none\">*</td><td>id:\u00a0123456</td><td>Blister <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-medicinal-product-package-type.html\">Medicinal Product Package Type</a>#100000073496)</span></td><td>28</td><td>PolyVinyl Chloride <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-package-material.html\">Package Material</a>#200000003222)</span></td></tr></table></div>"
},
"identifier" : [
{
"use" : "official",
"system" : "http://example.org/sid/product",
"value" : "EU/1/97/049/001"
}
],
"name" : "DrugX 75 mg tablet blister x28 tablets",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/medicinal-product-type",
"code" : "MedicinalProduct",
"display" : "Medicinal Product"
}
]
},
"packageFor" : [
{
"reference" : "MedicinalProductDefinition/800a51a2-d81d-49a4-a4eb-f2417d301837"
}
],
"status" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/publication-status",
"code" : "active",
"display" : "Active"
}
]
},
"statusDate" : "2018-06-23T08:38:00+02:00",
"containedItemQuantity" : [
{
"value" : 75,
"unit" : "mg"
}
],
"manufacturer" : [
{
"reference" : "Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75"
}
],
"packaging" : {
"identifier" : [
{
"system" : "http://example.org/sid/product",
"value" : "123456"
}
],
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/medicinal-product-package-type",
"code" : "100000073496",
"display" : "Blister"
}
]
},
"quantity" : 28,
"material" : [
{
"coding" : [
{
"system" : "http://hl7.org/fhir/package-material",
"code" : "200000003222",
"display" : "PolyVinyl Chloride"
}
]
}
]
}
}
},
{
"fullUrl" : "urn:uuid:373b9bf3-1fae-47a1-a7cd-230106def069",
"resource" : {
"resourceType" : "AdministrableProductDefinition",
"id" : "373b9bf3-1fae-47a1-a7cd-230106def069",
"meta" : {
"profile" : [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/AdministrableProductDefinition-uv-epi"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: AdministrableProductDefinition</b><a name=\"373b9bf3-1fae-47a1-a7cd-230106def069\"> </a></p><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\">Resource AdministrableProductDefinition "373b9bf3-1fae-47a1-a7cd-230106def069" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-AdministrableProductDefinition-uv-epi.html\">AdministrableProductDefinition (ePI)</a></p></div><p><b>identifier</b>: id:\u00a0DrugXphpidplaceholder</p><p><b>status</b>: active</p><p><b>formOf</b>: <a href=\"#MedicinalProductDefinition_800a51a2-d81d-49a4-a4eb-f2417d301837\">See above (MedicinalProductDefinition/800a51a2-d81d-49a4-a4eb-f2417d301837)</a></p><p><b>administrableDoseForm</b>: Tablet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-administrable-dose-form.html\">Administrable Dose Form</a>#100000073664)</span></p><p><b>unitOfPresentation</b>: Tablet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-unit-of-presentation.html\">Unit Of Presentation</a>#200000002152)</span></p><p><b>producedFrom</b>: <a href=\"#ManufacturedItemDefinition_3214f286-b8ec-4ef5-bc8d-0aec39d97468\">See above (ManufacturedItemDefinition/3214f286-b8ec-4ef5-bc8d-0aec39d97468)</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>Oral route <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://browser.ihtsdotools.org/\">SNOMED CT</a>#26643006)</span></td></tr></table></div>"
},
"identifier" : [
{
"system" : "https://www.who-umc.org/phpid",
"value" : "DrugXphpidplaceholder"
}
],
"status" : "active",
"formOf" : [
{
"reference" : "MedicinalProductDefinition/800a51a2-d81d-49a4-a4eb-f2417d301837"
}
],
"administrableDoseForm" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/administrable-dose-form",
"code" : "100000073664",
"display" : "Tablet"
}
]
},
"unitOfPresentation" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/unit-of-presentation",
"code" : "200000002152",
"display" : "Tablet"
}
]
},
"producedFrom" : [
{
"reference" : "ManufacturedItemDefinition/3214f286-b8ec-4ef5-bc8d-0aec39d97468"
}
],
"routeOfAdministration" : [
{
"code" : {
"coding" : [
{
"system" : "http://snomed.info/sct",
"code" : "26643006",
"display" : "Oral route"
}
]
}
}
]
}
},
{
"fullUrl" : "urn:uuid:3214f286-b8ec-4ef5-bc8d-0aec39d97468",
"resource" : {
"resourceType" : "ManufacturedItemDefinition",
"id" : "3214f286-b8ec-4ef5-bc8d-0aec39d97468",
"meta" : {
"profile" : [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ManufacturedItemDefinition-uv-epi"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ManufacturedItemDefinition</b><a name=\"3214f286-b8ec-4ef5-bc8d-0aec39d97468\"> </a></p><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\">Resource ManufacturedItemDefinition "3214f286-b8ec-4ef5-bc8d-0aec39d97468" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ManufacturedItemDefinition-uv-epi.html\">ManufacturedItemDefinition (ePI)</a></p></div><p><b>identifier</b>: id:\u00a0EU/1/96/007/035\u00a0(use:\u00a0OFFICIAL)</p><p><b>status</b>: active</p><p><b>manufacturedDoseForm</b>: Tablet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-manufactured-dose-form.html\">Manufactured Dose Form</a>#100000073664)</span></p><p><b>unitOfPresentation</b>: Tablet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-unit-of-presentation.html\">Unit Of Presentation</a>#200000002152)</span></p><p><b>manufacturer</b>: <a href=\"#Organization_d71bf884-90eb-47f9-81b7-fa81ecec7e75\">See above (Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75)</a></p></div>"
},
"identifier" : [
{
"use" : "official",
"system" : "https://spor.ema.europa.eu/pmswi/#/",
"value" : "EU/1/96/007/035"
}
],
"status" : "active",
"manufacturedDoseForm" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/manufactured-dose-form",
"code" : "100000073664",
"display" : "Tablet"
}
]
},
"unitOfPresentation" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/unit-of-presentation",
"code" : "200000002152",
"display" : "Tablet"
}
]
},
"manufacturer" : [
{
"reference" : "Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75"
}
]
}
},
{
"fullUrl" : "urn:uuid:745c01bc-936e-45ca-9880-57e97608f43e",
"resource" : {
"resourceType" : "Ingredient",
"id" : "745c01bc-936e-45ca-9880-57e97608f43e",
"meta" : {
"profile" : [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Ingredient</b><a name=\"745c01bc-936e-45ca-9880-57e97608f43e\"> </a></p><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\">Resource Ingredient "745c01bc-936e-45ca-9880-57e97608f43e" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-Ingredient-uv-epi.html\">Ingredient (ePI)</a></p></div><p><b>identifier</b>: id:\u00a0362O9ITL9D\u00a0(use:\u00a0OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: <a href=\"#ManufacturedItemDefinition_3214f286-b8ec-4ef5-bc8d-0aec39d97468\">See above (ManufacturedItemDefinition/3214f286-b8ec-4ef5-bc8d-0aec39d97468)</a></p><p><b>role</b>: Active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-ingredient-role.html\">Ingredient Role</a>#100000072072)</span></p><h3>Manufacturers</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Manufacturer</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"#Organization_d71bf884-90eb-47f9-81b7-fa81ecec7e75\">See above (Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75)</a></td></tr></table><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>acetaminophen <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-UNII.html\">Unique Ingredient Identifier (UNII)</a>#362O9ITL9D)</span></td></tr></table><h3>Strengths</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Presentation[x]</b></td><td><b>Basis</b></td></tr><tr><td style=\"display: none\">*</td><td>75 mg</td><td>active ingredient - basis of strength <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v3-RoleClass.html\">RoleClass</a>#ACTIB)</span></td></tr></table></blockquote></div>"
},
"identifier" : {
"use" : "official",
"system" : "http://fdasis.nlm.nih.gov",
"value" : "362O9ITL9D"
},
"status" : "active",
"for" : [
{
"reference" : "ManufacturedItemDefinition/3214f286-b8ec-4ef5-bc8d-0aec39d97468"
}
],
"role" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/ingredient-role",
"code" : "100000072072",
"display" : "Active"
}
]
},
"manufacturer" : [
{
"manufacturer" : {
"reference" : "Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75"
}
}
],
"substance" : {
"code" : {
"concept" : {
"coding" : [
{
"system" : "http://fdasis.nlm.nih.gov",
"code" : "362O9ITL9D",
"display" : "acetaminophen"
}
]
}
},
"strength" : [
{
"presentationQuantity" : {
"value" : 75,
"unit" : "mg"
},
"basis" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v3-RoleClass",
"code" : "ACTIB"
}
],
"text" : "active ingredient - basis of strength"
}
}
]
}
}
},
{
"fullUrl" : "urn:uuid:09c13040-8fd5-4818-972d-f01d4ee169b6",
"resource" : {
"resourceType" : "Ingredient",
"id" : "09c13040-8fd5-4818-972d-f01d4ee169b6",
"meta" : {
"profile" : [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Ingredient</b><a name=\"09c13040-8fd5-4818-972d-f01d4ee169b6\"> </a></p><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\">Resource Ingredient "09c13040-8fd5-4818-972d-f01d4ee169b6" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-Ingredient-uv-epi.html\">Ingredient (ePI)</a></p></div><p><b>identifier</b>: id:\u00a0ETJ7Z6XBU4\u00a0(use:\u00a0OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: <a href=\"#ManufacturedItemDefinition_3214f286-b8ec-4ef5-bc8d-0aec39d97468\">See above (ManufacturedItemDefinition/3214f286-b8ec-4ef5-bc8d-0aec39d97468)</a></p><p><b>role</b>: Excipient <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-ingredient-role.html\">Ingredient Role</a>#100000072082)</span></p><h3>Manufacturers</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Manufacturer</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"#Organization_d71bf884-90eb-47f9-81b7-fa81ecec7e75\">See above (Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75)</a></td></tr></table><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>Silicon dioxide <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-UNII.html\">Unique Ingredient Identifier (UNII)</a>#ETJ7Z6XBU4)</span></td></tr></table></blockquote></div>"
},
"identifier" : {
"use" : "official",
"system" : "http://fdasis.nlm.nih.gov",
"value" : "ETJ7Z6XBU4"
},
"status" : "active",
"for" : [
{
"reference" : "ManufacturedItemDefinition/3214f286-b8ec-4ef5-bc8d-0aec39d97468"
}
],
"role" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/ingredient-role",
"code" : "100000072082",
"display" : "Excipient"
}
]
},
"manufacturer" : [
{
"manufacturer" : {
"reference" : "Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75"
}
}
],
"substance" : {
"code" : {
"concept" : {
"coding" : [
{
"system" : "http://fdasis.nlm.nih.gov",
"code" : "ETJ7Z6XBU4",
"display" : "Silicon dioxide"
}
]
}
}
}
}
},
{
"fullUrl" : "urn:uuid:a4b7b60c-998f-4f93-89c7-860396af0fe3",
"resource" : {
"resourceType" : "Ingredient",
"id" : "a4b7b60c-998f-4f93-89c7-860396af0fe3",
"meta" : {
"profile" : [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Ingredient</b><a name=\"a4b7b60c-998f-4f93-89c7-860396af0fe3\"> </a></p><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\">Resource Ingredient "a4b7b60c-998f-4f93-89c7-860396af0fe3" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-Ingredient-uv-epi.html\">Ingredient (ePI)</a></p></div><p><b>identifier</b>: id:\u00a0R12CBM0EIZ\u00a0(use:\u00a0OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: <a href=\"#ManufacturedItemDefinition_3214f286-b8ec-4ef5-bc8d-0aec39d97468\">See above (ManufacturedItemDefinition/3214f286-b8ec-4ef5-bc8d-0aec39d97468)</a></p><p><b>role</b>: Excipient <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-ingredient-role.html\">Ingredient Role</a>#100000072082)</span></p><h3>Manufacturers</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Manufacturer</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"#Organization_d71bf884-90eb-47f9-81b7-fa81ecec7e75\">See above (Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75)</a></td></tr></table><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>Carnauba wax <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-UNII.html\">Unique Ingredient Identifier (UNII)</a>#R12CBM0EIZ)</span></td></tr></table></blockquote></div>"
},
"identifier" : {
"use" : "official",
"system" : "http://fdasis.nlm.nih.gov",
"value" : "R12CBM0EIZ"
},
"status" : "active",
"for" : [
{
"reference" : "ManufacturedItemDefinition/3214f286-b8ec-4ef5-bc8d-0aec39d97468"
}
],
"role" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/ingredient-role",
"code" : "100000072082",
"display" : "Excipient"
}
]
},
"manufacturer" : [
{
"manufacturer" : {
"reference" : "Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75"
}
}
],
"substance" : {
"code" : {
"concept" : {
"coding" : [
{
"system" : "http://fdasis.nlm.nih.gov",
"code" : "R12CBM0EIZ",
"display" : "Carnauba wax"
}
]
}
}
}
}
},
{
"fullUrl" : "urn:uuid:fbf58407-83d3-42db-be3d-506b2006d431",
"resource" : {
"resourceType" : "Ingredient",
"id" : "fbf58407-83d3-42db-be3d-506b2006d431",
"meta" : {
"profile" : [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Ingredient</b><a name=\"fbf58407-83d3-42db-be3d-506b2006d431\"> </a></p><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\">Resource Ingredient "fbf58407-83d3-42db-be3d-506b2006d431" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-Ingredient-uv-epi.html\">Ingredient (ePI)</a></p></div><p><b>identifier</b>: id:\u00a0M28OL1HH48\u00a0(use:\u00a0OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: <a href=\"#ManufacturedItemDefinition_3214f286-b8ec-4ef5-bc8d-0aec39d97468\">See above (ManufacturedItemDefinition/3214f286-b8ec-4ef5-bc8d-0aec39d97468)</a></p><p><b>role</b>: Excipient <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-ingredient-role.html\">Ingredient Role</a>#100000072082)</span></p><h3>Manufacturers</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Manufacturer</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"#Organization_d71bf884-90eb-47f9-81b7-fa81ecec7e75\">See above (Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75)</a></td></tr></table><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>Croscarmellose sodium <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-UNII.html\">Unique Ingredient Identifier (UNII)</a>#M28OL1HH48)</span></td></tr></table></blockquote></div>"
},
"identifier" : {
"use" : "official",
"system" : "http://fdasis.nlm.nih.gov",
"value" : "M28OL1HH48"
},
"status" : "active",
"for" : [
{
"reference" : "ManufacturedItemDefinition/3214f286-b8ec-4ef5-bc8d-0aec39d97468"
}
],
"role" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/ingredient-role",
"code" : "100000072082",
"display" : "Excipient"
}
]
},
"manufacturer" : [
{
"manufacturer" : {
"reference" : "Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75"
}
}
],
"substance" : {
"code" : {
"concept" : {
"coding" : [
{
"system" : "http://fdasis.nlm.nih.gov",
"code" : "M28OL1HH48",
"display" : "Croscarmellose sodium"
}
]
}
}
}
}
},
{
"fullUrl" : "urn:uuid:1c10b441-6bd3-40b8-b14b-514e7c2f79d0",
"resource" : {
"resourceType" : "Ingredient",
"id" : "1c10b441-6bd3-40b8-b14b-514e7c2f79d0",
"meta" : {
"profile" : [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Ingredient</b><a name=\"1c10b441-6bd3-40b8-b14b-514e7c2f79d0\"> </a></p><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\">Resource Ingredient "1c10b441-6bd3-40b8-b14b-514e7c2f79d0" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-Ingredient-uv-epi.html\">Ingredient (ePI)</a></p></div><p><b>identifier</b>: id:\u00a03NXW29V3WO\u00a0(use:\u00a0OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: <a href=\"#ManufacturedItemDefinition_3214f286-b8ec-4ef5-bc8d-0aec39d97468\">See above (ManufacturedItemDefinition/3214f286-b8ec-4ef5-bc8d-0aec39d97468)</a></p><p><b>role</b>: Excipient <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-ingredient-role.html\">Ingredient Role</a>#100000072082)</span></p><h3>Manufacturers</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Manufacturer</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"#Organization_d71bf884-90eb-47f9-81b7-fa81ecec7e75\">See above (Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75)</a></td></tr></table><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>Hypromellose <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-UNII.html\">Unique Ingredient Identifier (UNII)</a>#3NXW29V3WO)</span></td></tr></table></blockquote></div>"
},
"identifier" : {
"use" : "official",
"system" : "http://fdasis.nlm.nih.gov",
"value" : "3NXW29V3WO"
},
"status" : "active",
"for" : [
{
"reference" : "ManufacturedItemDefinition/3214f286-b8ec-4ef5-bc8d-0aec39d97468"
}
],
"role" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/ingredient-role",
"code" : "100000072082",
"display" : "Excipient"
}
]
},
"manufacturer" : [
{
"manufacturer" : {
"reference" : "Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75"
}
}
],
"substance" : {
"code" : {
"concept" : {
"coding" : [
{
"system" : "http://fdasis.nlm.nih.gov",
"code" : "3NXW29V3WO",
"display" : "Hypromellose"
}
]
}
}
}
}
},
{
"fullUrl" : "urn:uuid:7a3c0b14-2473-4541-9e45-a24d24cceddf",
"resource" : {
"resourceType" : "Ingredient",
"id" : "7a3c0b14-2473-4541-9e45-a24d24cceddf",
"meta" : {
"profile" : [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Ingredient</b><a name=\"7a3c0b14-2473-4541-9e45-a24d24cceddf\"> </a></p><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\">Resource Ingredient "7a3c0b14-2473-4541-9e45-a24d24cceddf" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-Ingredient-uv-epi.html\">Ingredient (ePI)</a></p></div><p><b>identifier</b>: id:\u00a0EWQ57Q8I5X\u00a0(use:\u00a0OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: <a href=\"#ManufacturedItemDefinition_3214f286-b8ec-4ef5-bc8d-0aec39d97468\">See above (ManufacturedItemDefinition/3214f286-b8ec-4ef5-bc8d-0aec39d97468)</a></p><p><b>role</b>: Excipient <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-ingredient-role.html\">Ingredient Role</a>#100000072082)</span></p><h3>Manufacturers</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Manufacturer</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"#Organization_d71bf884-90eb-47f9-81b7-fa81ecec7e75\">See above (Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75)</a></td></tr></table><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>Lactose Monohydrate <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-UNII.html\">Unique Ingredient Identifier (UNII)</a>#EWQ57Q8I5X)</span></td></tr></table></blockquote></div>"
},
"identifier" : {
"use" : "official",
"system" : "http://fdasis.nlm.nih.gov",
"value" : "EWQ57Q8I5X"
},
"status" : "active",
"for" : [
{
"reference" : "ManufacturedItemDefinition/3214f286-b8ec-4ef5-bc8d-0aec39d97468"
}
],
"role" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/ingredient-role",
"code" : "100000072082",
"display" : "Excipient"
}
]
},
"manufacturer" : [
{
"manufacturer" : {
"reference" : "Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75"
}
}
],
"substance" : {
"code" : {
"concept" : {
"coding" : [
{
"system" : "http://fdasis.nlm.nih.gov",
"code" : "EWQ57Q8I5X",
"display" : "Lactose Monohydrate"
}
]
}
}
}
}
},
{
"fullUrl" : "urn:uuid:ceba5cd1-321f-4bc3-b203-92d97fcf472e",
"resource" : {
"resourceType" : "Ingredient",
"id" : "ceba5cd1-321f-4bc3-b203-92d97fcf472e",
"meta" : {
"profile" : [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Ingredient</b><a name=\"ceba5cd1-321f-4bc3-b203-92d97fcf472e\"> </a></p><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\">Resource Ingredient "ceba5cd1-321f-4bc3-b203-92d97fcf472e" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-Ingredient-uv-epi.html\">Ingredient (ePI)</a></p></div><p><b>identifier</b>: id:\u00a0SA1B764746\u00a0(use:\u00a0OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: <a href=\"#ManufacturedItemDefinition_3214f286-b8ec-4ef5-bc8d-0aec39d97468\">See above (ManufacturedItemDefinition/3214f286-b8ec-4ef5-bc8d-0aec39d97468)</a></p><p><b>role</b>: Excipient <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-ingredient-role.html\">Ingredient Role</a>#100000072082)</span></p><h3>Manufacturers</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Manufacturer</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"#Organization_d71bf884-90eb-47f9-81b7-fa81ecec7e75\">See above (Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75)</a></td></tr></table><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>Macrogol 3000 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-UNII.html\">Unique Ingredient Identifier (UNII)</a>#SA1B764746)</span></td></tr></table></blockquote></div>"
},
"identifier" : {
"use" : "official",
"system" : "http://fdasis.nlm.nih.gov",
"value" : "SA1B764746"
},
"status" : "active",
"for" : [
{
"reference" : "ManufacturedItemDefinition/3214f286-b8ec-4ef5-bc8d-0aec39d97468"
}
],
"role" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/ingredient-role",
"code" : "100000072082",
"display" : "Excipient"
}
]
},
"manufacturer" : [
{
"manufacturer" : {
"reference" : "Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75"
}
}
],
"substance" : {
"code" : {
"concept" : {
"coding" : [
{
"system" : "http://fdasis.nlm.nih.gov",
"code" : "SA1B764746",
"display" : "Macrogol 3000"
}
]
}
}
}
}
},
{
"fullUrl" : "urn:uuid:eee155e8-e442-491d-9a82-7af3cefac57f",
"resource" : {
"resourceType" : "Ingredient",
"id" : "eee155e8-e442-491d-9a82-7af3cefac57f",
"meta" : {
"profile" : [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Ingredient</b><a name=\"eee155e8-e442-491d-9a82-7af3cefac57f\"> </a></p><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\">Resource Ingredient "eee155e8-e442-491d-9a82-7af3cefac57f" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-Ingredient-uv-epi.html\">Ingredient (ePI)</a></p></div><p><b>identifier</b>: id:\u00a070097M6I30\u00a0(use:\u00a0OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: <a href=\"#ManufacturedItemDefinition_3214f286-b8ec-4ef5-bc8d-0aec39d97468\">See above (ManufacturedItemDefinition/3214f286-b8ec-4ef5-bc8d-0aec39d97468)</a></p><p><b>role</b>: Excipient <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-ingredient-role.html\">Ingredient Role</a>#100000072082)</span></p><h3>Manufacturers</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Manufacturer</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"#Organization_d71bf884-90eb-47f9-81b7-fa81ecec7e75\">See above (Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75)</a></td></tr></table><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>Magnesium stearate <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-UNII.html\">Unique Ingredient Identifier (UNII)</a>#70097M6I30)</span></td></tr></table></blockquote></div>"
},
"identifier" : {
"use" : "official",
"system" : "http://fdasis.nlm.nih.gov",
"value" : "70097M6I30"
},
"status" : "active",
"for" : [
{
"reference" : "ManufacturedItemDefinition/3214f286-b8ec-4ef5-bc8d-0aec39d97468"
}
],
"role" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/ingredient-role",
"code" : "100000072082",
"display" : "Excipient"
}
]
},
"manufacturer" : [
{
"manufacturer" : {
"reference" : "Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75"
}
}
],
"substance" : {
"code" : {
"concept" : {
"coding" : [
{
"system" : "http://fdasis.nlm.nih.gov",
"code" : "70097M6I30",
"display" : "Magnesium stearate"
}
]
}
}
}
}
},
{
"fullUrl" : "urn:uuid:1cdfb0bc-55f0-43ff-b750-8f3a0d9970bd",
"resource" : {
"resourceType" : "Ingredient",
"id" : "1cdfb0bc-55f0-43ff-b750-8f3a0d9970bd",
"meta" : {
"profile" : [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Ingredient</b><a name=\"1cdfb0bc-55f0-43ff-b750-8f3a0d9970bd\"> </a></p><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\">Resource Ingredient "1cdfb0bc-55f0-43ff-b750-8f3a0d9970bd" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-Ingredient-uv-epi.html\">Ingredient (ePI)</a></p></div><p><b>identifier</b>: id:\u00a0OP1R32D61U\u00a0(use:\u00a0OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: <a href=\"#ManufacturedItemDefinition_3214f286-b8ec-4ef5-bc8d-0aec39d97468\">See above (ManufacturedItemDefinition/3214f286-b8ec-4ef5-bc8d-0aec39d97468)</a></p><p><b>role</b>: Excipient <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-ingredient-role.html\">Ingredient Role</a>#100000072082)</span></p><h3>Manufacturers</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Manufacturer</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"#Organization_d71bf884-90eb-47f9-81b7-fa81ecec7e75\">See above (Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75)</a></td></tr></table><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>Microcrystalline cellulose <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-UNII.html\">Unique Ingredient Identifier (UNII)</a>#OP1R32D61U)</span></td></tr></table></blockquote></div>"
},
"identifier" : {
"use" : "official",
"system" : "http://fdasis.nlm.nih.gov",
"value" : "OP1R32D61U"
},
"status" : "active",
"for" : [
{
"reference" : "ManufacturedItemDefinition/3214f286-b8ec-4ef5-bc8d-0aec39d97468"
}
],
"role" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/ingredient-role",
"code" : "100000072082",
"display" : "Excipient"
}
]
},
"manufacturer" : [
{
"manufacturer" : {
"reference" : "Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75"
}
}
],
"substance" : {
"code" : {
"concept" : {
"coding" : [
{
"system" : "http://fdasis.nlm.nih.gov",
"code" : "OP1R32D61U",
"display" : "Microcrystalline cellulose"
}
]
}
}
}
}
},
{
"fullUrl" : "urn:uuid:a88891dc-7e9e-4d84-b462-95e53de3b6a6",
"resource" : {
"resourceType" : "Ingredient",
"id" : "a88891dc-7e9e-4d84-b462-95e53de3b6a6",
"meta" : {
"profile" : [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Ingredient</b><a name=\"a88891dc-7e9e-4d84-b462-95e53de3b6a6\"> </a></p><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\">Resource Ingredient "a88891dc-7e9e-4d84-b462-95e53de3b6a6" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-Ingredient-uv-epi.html\">Ingredient (ePI)</a></p></div><p><b>identifier</b>: id:\u00a015FIX9V2JP\u00a0(use:\u00a0OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: <a href=\"#ManufacturedItemDefinition_3214f286-b8ec-4ef5-bc8d-0aec39d97468\">See above (ManufacturedItemDefinition/3214f286-b8ec-4ef5-bc8d-0aec39d97468)</a></p><p><b>role</b>: Excipient <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-ingredient-role.html\">Ingredient Role</a>#100000072082)</span></p><h3>Manufacturers</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Manufacturer</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"#Organization_d71bf884-90eb-47f9-81b7-fa81ecec7e75\">See above (Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75)</a></td></tr></table><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>Titanium Dioxide <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-UNII.html\">Unique Ingredient Identifier (UNII)</a>#15FIX9V2JP)</span></td></tr></table></blockquote></div>"
},
"identifier" : {
"use" : "official",
"system" : "http://fdasis.nlm.nih.gov",
"value" : "15FIX9V2JP"
},
"status" : "active",
"for" : [
{
"reference" : "ManufacturedItemDefinition/3214f286-b8ec-4ef5-bc8d-0aec39d97468"
}
],
"role" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/ingredient-role",
"code" : "100000072082",
"display" : "Excipient"
}
]
},
"manufacturer" : [
{
"manufacturer" : {
"reference" : "Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75"
}
}
],
"substance" : {
"code" : {
"concept" : {
"coding" : [
{
"system" : "http://fdasis.nlm.nih.gov",
"code" : "15FIX9V2JP",
"display" : "Titanium Dioxide"
}
]
}
}
}
}
},
{
"fullUrl" : "urn:uuid:83f4a22f-9e5e-4941-9fdb-339a0f1f2055",
"resource" : {
"resourceType" : "ClinicalUseDefinition",
"id" : "83f4a22f-9e5e-4941-9fdb-339a0f1f2055",
"meta" : {
"profile" : [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-contraindication-uv-epi"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ClinicalUseDefinition</b><a name=\"83f4a22f-9e5e-4941-9fdb-339a0f1f2055\"> </a></p><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\">Resource ClinicalUseDefinition "83f4a22f-9e5e-4941-9fdb-339a0f1f2055" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ClinicalUseDefinition-contraindication-uv-epi.html\">ClinicalUseDefinition Contraindication (ePI)</a></p></div><p><b>identifier</b>: id:\u00a0contra-example-1</p><p><b>type</b>: contraindication</p><p><b>subject</b>: <a href=\"#MedicinalProductDefinition_800a51a2-d81d-49a4-a4eb-f2417d301837\">See above (MedicinalProductDefinition/800a51a2-d81d-49a4-a4eb-f2417d301837)</a></p><blockquote><p><b>contraindication</b></p><h3>DiseaseSymptomProcedures</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td>Gastrointestinal disorders <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-mdr.html\">MedDRA</a>#10017947)</span></td></tr></table></blockquote></div>"
},
"identifier" : [
{
"system" : "http://example.org/sid",
"value" : "contra-example-1"
}
],
"type" : "contraindication",
"subject" : [
{
"reference" : "MedicinalProductDefinition/800a51a2-d81d-49a4-a4eb-f2417d301837"
}
],
"contraindication" : {
"diseaseSymptomProcedure" : {
"concept" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/mdr",
"code" : "10017947",
"display" : "Gastrointestinal disorders"
}
]
}
}
}
}
},
{
"fullUrl" : "urn:uuid:bac1d528-6430-4310-bde6-b8b3471ce35a",
"resource" : {
"resourceType" : "ClinicalUseDefinition",
"id" : "bac1d528-6430-4310-bde6-b8b3471ce35a",
"meta" : {
"profile" : [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-indication-uv-epi"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ClinicalUseDefinition</b><a name=\"bac1d528-6430-4310-bde6-b8b3471ce35a\"> </a></p><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\">Resource ClinicalUseDefinition "bac1d528-6430-4310-bde6-b8b3471ce35a" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ClinicalUseDefinition-indication-uv-epi.html\">ClinicalUseDefinition Indication (ePI)</a></p></div><p><b>identifier</b>: id:\u00a0indication-example-1</p><p><b>type</b>: indication</p><p><b>subject</b>: <a href=\"#MedicinalProductDefinition_800a51a2-d81d-49a4-a4eb-f2417d301837\">See above (MedicinalProductDefinition/800a51a2-d81d-49a4-a4eb-f2417d301837)</a></p><blockquote><p><b>indication</b></p><h3>DiseaseSymptomProcedures</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td>Psoriasis <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-mdr.html\">MedDRA</a>#10037156)</span></td></tr></table></blockquote></div>"
},
"identifier" : [
{
"system" : "http://example.org/sid",
"value" : "indication-example-1"
}
],
"type" : "indication",
"subject" : [
{
"reference" : "MedicinalProductDefinition/800a51a2-d81d-49a4-a4eb-f2417d301837"
}
],
"indication" : {
"diseaseSymptomProcedure" : {
"concept" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/mdr",
"code" : "10037156",
"display" : "Psoriasis"
}
]
}
}
}
}
},
{
"fullUrl" : "urn:uuid:e60575aa-e7b3-4461-a456-d310514f4041",
"resource" : {
"resourceType" : "ClinicalUseDefinition",
"id" : "e60575aa-e7b3-4461-a456-d310514f4041",
"meta" : {
"profile" : [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-interaction-uv-epi"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ClinicalUseDefinition</b><a name=\"e60575aa-e7b3-4461-a456-d310514f4041\"> </a></p><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\">Resource ClinicalUseDefinition "e60575aa-e7b3-4461-a456-d310514f4041" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ClinicalUseDefinition-interaction-uv-epi.html\">ClinicalUseDefinition Interaction (ePI)</a></p></div><p><b>identifier</b>: id:\u00a0YL5FZ2Y5U1\u00a0(use:\u00a0OFFICIAL)</p><p><b>type</b>: interaction</p><p><b>subject</b>: <a href=\"#MedicinalProductDefinition_800a51a2-d81d-49a4-a4eb-f2417d301837\">See above (MedicinalProductDefinition/800a51a2-d81d-49a4-a4eb-f2417d301837)</a></p><blockquote><p><b>interaction</b></p><h3>Interactants</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Item[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>METHOTREXATE <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-UNII.html\">Unique Ingredient Identifier (UNII)</a>#YL5FZ2Y5U1)</span></td></tr></table></blockquote></div>"
},
"identifier" : [
{
"use" : "official",
"system" : "http://fdasis.nlm.nih.gov",
"value" : "YL5FZ2Y5U1"
}
],
"type" : "interaction",
"subject" : [
{
"reference" : "MedicinalProductDefinition/800a51a2-d81d-49a4-a4eb-f2417d301837"
}
],
"interaction" : {
"interactant" : [
{
"itemCodeableConcept" : {
"coding" : [
{
"system" : "http://fdasis.nlm.nih.gov",
"code" : "YL5FZ2Y5U1",
"display" : "METHOTREXATE"
}
]
}
}
]
}
}
},
{
"fullUrl" : "urn:uuid:4312f8ec-43b6-4b25-9fca-d61a1188bfea",
"resource" : {
"resourceType" : "ClinicalUseDefinition",
"id" : "4312f8ec-43b6-4b25-9fca-d61a1188bfea",
"meta" : {
"profile" : [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-undesirableEffect-uv-epi"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ClinicalUseDefinition</b><a name=\"4312f8ec-43b6-4b25-9fca-d61a1188bfea\"> </a></p><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\">Resource ClinicalUseDefinition "4312f8ec-43b6-4b25-9fca-d61a1188bfea" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ClinicalUseDefinition-undesirableEffect-uv-epi.html\">ClinicalUseDefinition Undesirable Effect (ePI)</a></p></div><p><b>identifier</b>: id:\u00a0YL5FZ2Y5U1\u00a0(use:\u00a0OFFICIAL)</p><p><b>type</b>: undesirable-effect</p><p><b>subject</b>: <a href=\"#MedicinalProductDefinition_800a51a2-d81d-49a4-a4eb-f2417d301837\">See above (MedicinalProductDefinition/800a51a2-d81d-49a4-a4eb-f2417d301837)</a></p><blockquote><p><b>undesirableEffect</b></p><h3>SymptomConditionEffects</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td>Dysergia <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://browser.ihtsdotools.org/\">SNOMED CT</a>#2767007)</span></td></tr></table><p><b>frequencyOfOccurrence</b>: Rare <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-undesirable-effect-frequency.html\">Undesirabl Effect Frequency</a>#Rare)</span></p></blockquote></div>"
},
"identifier" : [
{
"use" : "official",
"system" : "http://fdasis.nlm.nih.gov",
"value" : "YL5FZ2Y5U1"
}
],
"type" : "undesirable-effect",
"subject" : [
{
"reference" : "MedicinalProductDefinition/800a51a2-d81d-49a4-a4eb-f2417d301837"
}
],
"undesirableEffect" : {
"symptomConditionEffect" : {
"concept" : {
"coding" : [
{
"system" : "http://snomed.info/sct",
"code" : "2767007",
"display" : "Dysergia"
}
]
}
},
"frequencyOfOccurrence" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/undesirable-effect-frequency",
"code" : "Rare",
"display" : "Rare"
}
]
}
}
}
},
{
"fullUrl" : "urn:uuid:ac21a804-cafa-41ff-b644-a14c8003edeb",
"resource" : {
"resourceType" : "ClinicalUseDefinition",
"id" : "ac21a804-cafa-41ff-b644-a14c8003edeb",
"meta" : {
"profile" : [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-warning-uv-epi"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ClinicalUseDefinition</b><a name=\"ac21a804-cafa-41ff-b644-a14c8003edeb\"> </a></p><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\">Resource ClinicalUseDefinition "ac21a804-cafa-41ff-b644-a14c8003edeb" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ClinicalUseDefinition-warning-uv-epi.html\">ClinicalUseDefinition Warning (ePI)</a></p></div><p><b>identifier</b>: id:\u00a0warning-example-1</p><p><b>type</b>: warning</p><p><b>subject</b>: <a href=\"#MedicinalProductDefinition_800a51a2-d81d-49a4-a4eb-f2417d301837\">See above (MedicinalProductDefinition/800a51a2-d81d-49a4-a4eb-f2417d301837)</a></p><h3>Warnings</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Description</b></td></tr><tr><td style=\"display: none\">*</td><td>Symptomatic hypotension, especially after the first dose, may occur in patients.</td></tr></table></div>"
},
"identifier" : [
{
"system" : "http://example.org/sid",
"value" : "warning-example-1"
}
],
"type" : "warning",
"subject" : [
{
"reference" : "MedicinalProductDefinition/800a51a2-d81d-49a4-a4eb-f2417d301837"
}
],
"warning" : {
"description" : "Symptomatic hypotension, especially after the first dose, may occur in patients."
}
}
},
{
"fullUrl" : "urn:uuid:da33bd51-a726-4232-aaa0-4168b9bfe249",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "da33bd51-a726-4232-aaa0-4168b9bfe249",
"meta" : {
"profile" : [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"da33bd51-a726-4232-aaa0-4168b9bfe249\"> </a></p><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\">Resource SubstanceDefinition "da33bd51-a726-4232-aaa0-4168b9bfe249" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-SubstanceDefinition-uv-epi.html\">SubstanceDefinition (ePI)</a></p></div><p><b>identifier</b>: id:\u00a0362O9ITL9D\u00a0(use:\u00a0OFFICIAL)</p><p><b>version</b>: 1</p><p><b>status</b>: Active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-publication-status.html\">PublicationStatus</a>#active)</span></p><p><b>description</b>: White to off-white, biconvex, and oval-shaped with the number 1234 engraved on the other side.</p><p><b>manufacturer</b>: <a href=\"#Organization_d71bf884-90eb-47f9-81b7-fa81ecec7e75\">See above (Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75)</a></p><h3>MolecularWeights</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Amount</b></td></tr><tr><td style=\"display: none\">*</td><td>exact <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td>151.6</td></tr></table><h3>Structures</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>MolecularFormula</b></td></tr><tr><td style=\"display: none\">*</td><td>C8H9NO2</td></tr></table><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td>acetaminophen</td><td>Scientific <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-substance-name-type.html\">Substance Name Type</a>#Scientific)</span></td></tr></table></div>"
},
"identifier" : [
{
"use" : "official",
"system" : "https://gsrs.ncats.nih.gov/ginas/app/beta",
"value" : "362O9ITL9D"
}
],
"version" : "1",
"status" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/publication-status",
"code" : "active"
}
]
},
"description" : "White to off-white, biconvex, and oval-shaped with the number 1234 engraved on the other side.",
"manufacturer" : [
{
"reference" : "Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75"
}
],
"molecularWeight" : [
{
"type" : {
"text" : "exact"
},
"amount" : {
"value" : 151.6
}
}
],
"structure" : {
"molecularFormula" : "C8H9NO2"
},
"name" : [
{
"name" : "acetaminophen",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/substance-name-type",
"code" : "Scientific"
}
],
"text" : "Scientific"
}
}
]
}
}
]
}
IG © 2022+ HL7 International - Biomedical Research & Regulation Work Group. Package hl7.fhir.uv.emedicinal-product-info#1.0.0 based on FHIR 5.0.0. Generated 2023-07-26
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