Vulcan ePI FHIR Implementation Guide
0.1.0 - CI Build

Vulcan ePI FHIR Implementation Guide - Local Development build (v0.1.0). See the Directory of published versions

: Vulcan Dovato FHIR Package Insert EMA - TTL Representation

Raw ttl | Download


@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

 a fhir:Bundle;
  fhir:nodeRole fhir:treeRoot;
  fhir:Resource.id [ fhir:value "cfsb1651596479132"];
  fhir:Bundle.identifier [
     fhir:Identifier.system [ fhir:value "https://www.gravitatehealth.eu/sid/doc" ];
     fhir:Identifier.value [ fhir:value "EU/1/19/1370/001" ]
  ];
  fhir:Bundle.type [ fhir:value "document"];
  fhir:Bundle.timestamp [ fhir:value "2011-06-23T08:38:00+02:00"^^xsd:dateTime];
  fhir:Bundle.entry [
     fhir:index 0;
     fhir:Bundle.entry.resource [
       a fhir:Composition;
       fhir:Resource.id [ fhir:value "cfsb1651231019151" ];
       fhir:Resource.language [ fhir:value "en" ];
       fhir:DomainResource.text [
         fhir:Narrative.status [ fhir:value "generated" ];
         fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"en\" lang=\"en\"><p><b>Generated Narrative: Composition</b></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 \"cfsb1651231019151\"  (Language \"en\") </p></div><p><b>status</b>: final</p><p><b>type</b>: Package Leaflet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#100000155538)</span></p><p><b>date</b>: 2022-04-29 01:28:17+0000</p><p><b>author</b>: <a href=\"#Organization_cfsb1651149636159\">See above (Organization/cfsb1651149636159)</a></p><p><b>title</b>: TEST PURPOSES ONLY - Dovato 50 mg/300 mg film-coated tablets</p><p><b>confidentiality</b>: U</p><h3>Attesters</h3><table class=\"grid\"><tr><td>-</td><td><b>Mode</b></td><td><b>Time</b></td></tr><tr><td>*</td><td>Official <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://build.fhir.org/codesystem-composition-attestation-mode.html\">CompositionAttestationMode</a>#official)</span></td><td>2002-08-01 01:28:17+0000</td></tr></table></div>"       ];
       fhir:Composition.status [ fhir:value "final" ];
       fhir:Composition.type [
         fhir:CodeableConcept.coding [
           fhir:index 0;
           fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/" ];
           fhir:Coding.code [ fhir:value "100000155538" ]         ];
         fhir:CodeableConcept.text [ fhir:value "Package Leaflet" ]       ];
       fhir:Composition.subject [
         fhir:Reference.reference [ fhir:value "RegulatedAuthorization/cfsb1651148079894" ]       ];
       fhir:Composition.date [ fhir:value "2022-04-29T13:28:17Z"^^xsd:dateTime ];
       fhir:Composition.author [
         fhir:index 0;
         fhir:Reference.reference [ fhir:value "Organization/cfsb1651149636159" ]       ];
       fhir:Composition.title [ fhir:value "TEST PURPOSES ONLY - Dovato 50 mg/300 mg film-coated tablets" ];
       fhir:Composition.confidentiality [ fhir:value "U" ];
       fhir:Composition.attester [
         fhir:index 0;
         fhir:Composition.attester.mode [
           fhir:CodeableConcept.coding [
             fhir:index 0;
             fhir:Coding.system [ fhir:value "http://hl7.org/fhir/composition-attestation-mode" ];
             fhir:Coding.code [ fhir:value "official" ]           ]         ];
         fhir:Composition.attester.time [ fhir:value "2002-08-01T13:28:17Z"^^xsd:dateTime ]       ];
       fhir:Composition.section [
         fhir:index 0;
         fhir:Composition.section.title [ fhir:value "B. Package Leaflet" ];
         fhir:Composition.section.code [
           fhir:CodeableConcept.coding [
             fhir:index 0;
             fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/" ];
             fhir:Coding.code [ fhir:value "100000155538" ]           ];
           fhir:CodeableConcept.text [ fhir:value "B. PACKAGE LEAFLET" ]         ];
         fhir:Composition.section.text [
           fhir:Narrative.status [ fhir:value "additional" ];
           fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\">Package leaflet: Information for the patient Dovato 50 mg/300 mg film-coated tablets dolutegravir/lamivudine Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.<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>"         ]       ], [
         fhir:index 1;
         fhir:Composition.section.title [ fhir:value "What is in this leaflet" ];
         fhir:Composition.section.code [
           fhir:CodeableConcept.coding [
             fhir:index 0;
             fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/" ];
             fhir:Coding.code [ fhir:value "100000155538-0" ]           ];
           fhir:CodeableConcept.text [ fhir:value "B. PACKAGE LEAFLET" ]         ];
         fhir:Composition.section.text [
           fhir:Narrative.status [ fhir:value "additional" ];
           fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\">What in this leaflet<ol><li>What Dovato is and what it is used for</li><li>What you need to know before you take Dovato</li><li>How to take Dovato</li><li>Possible side effects</li><li>How to store Dovato</li><li>Contents of the pack and other information</li></ol></div>"         ]       ], [
         fhir:index 2;
         fhir:Composition.section.title [ fhir:value "1. What Dovato is and what it is used for" ];
         fhir:Composition.section.code [
           fhir:CodeableConcept.coding [
             fhir:index 0;
             fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/" ];
             fhir:Coding.code [ fhir:value "100000155538-1" ]           ];
           fhir:CodeableConcept.text [ fhir:value "B. PACKAGE LEAFLET" ]         ];
         fhir:Composition.section.text [
           fhir:Narrative.status [ fhir:value "additional" ];
           fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><b>1. What Dovato is and what it is used for</b> Dovato is a medicine that contains two active ingredients used to treat human immunodeficiency virus (HIV) infection: dolutegravir and lamivudine.</div>"         ]       ], [
         fhir:index 3;
         fhir:Composition.section.title [ fhir:value "2. What you need to know before you take Dovato" ];
         fhir:Composition.section.code [
           fhir:CodeableConcept.coding [
             fhir:index 0;
             fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/" ];
             fhir:Coding.code [ fhir:value "100000155538-2" ]           ];
           fhir:CodeableConcept.text [ fhir:value "B. PACKAGE LEAFLET" ]         ];
         fhir:Composition.section.text [
           fhir:Narrative.status [ fhir:value "additional" ];
           fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><b>2. What you need to know before you take Dovato</b> Do not take Dovato<ul><li>if you are allergic (hypersensitive) to dolutegravir or lamivudine or any of the other ingredients of this medicine (listed in section 6).</li><li>If you are taking a medicine called fampridine (also known as dalfampridine; used in multiple sclerosis).</li></ul></div>"         ]       ], [
         fhir:index 4;
         fhir:Composition.section.title [ fhir:value "3. How to take Dovato" ];
         fhir:Composition.section.code [
           fhir:CodeableConcept.coding [
             fhir:index 0;
             fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/" ];
             fhir:Coding.code [ fhir:value "100000155538-3" ]           ];
           fhir:CodeableConcept.text [ fhir:value "B. PACKAGE LEAFLET" ]         ];
         fhir:Composition.section.text [
           fhir:Narrative.status [ fhir:value "additional" ];
           fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><b>How to take Dovato</b><p>Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure</p><ul><li>The recommended dose of Dovato is <b>one tablet once a day.</b></li><li>If you are taking a medicine called fampridine (also known as dalfampridine; used in multiple sclerosis).</li></ul></div>"         ]       ], [
         fhir:index 5;
         fhir:Composition.section.title [ fhir:value "4. Possible side effects" ];
         fhir:Composition.section.code [
           fhir:CodeableConcept.coding [
             fhir:index 0;
             fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/" ];
             fhir:Coding.code [ fhir:value "100000155538-4" ]           ];
           fhir:CodeableConcept.text [ fhir:value "B. PACKAGE LEAFLET" ]         ];
         fhir:Composition.section.text [
           fhir:Narrative.status [ fhir:value "additional" ];
           fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>4. Possible side effects</b></p><p>Like all medicines, this medicine can cause side effects, although not everybody gets them,<b>so it is very important to talk to your doctor about any changes in your health</b></p></div>"         ]       ], [
         fhir:index 6;
         fhir:Composition.section.title [ fhir:value "5. How to store Dovato" ];
         fhir:Composition.section.code [
           fhir:CodeableConcept.coding [
             fhir:index 0;
             fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/" ];
             fhir:Coding.code [ fhir:value "100000155538-5" ]           ];
           fhir:CodeableConcept.text [ fhir:value "B. PACKAGE LEAFLET" ]         ];
         fhir:Composition.section.text [
           fhir:Narrative.status [ fhir:value "additional" ];
           fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><b>5. How to store Dovato</b><p>Keep this medicine out of the sight and reach of children.</p><p>Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. The expiry date refers to the last day of that month.</p><p>This medicine does not require any special storage conditions.</p><p>Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.</p></div>"         ]       ], [
         fhir:index 7;
         fhir:Composition.section.title [ fhir:value "6. Contents of the pack and other information" ];
         fhir:Composition.section.code [
           fhir:CodeableConcept.coding [
             fhir:index 0;
             fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/" ];
             fhir:Coding.code [ fhir:value "100000155538-6" ]           ];
           fhir:CodeableConcept.text [ fhir:value "B. PACKAGE LEAFLET" ]         ];
         fhir:Composition.section.text [
           fhir:Narrative.status [ fhir:value "additional" ];
           fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><b>6. Contents of the pack and other information</b> <b>What Dovato contains</b><ul><li>The active substances are dolutegravir and lamivudine. Each tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir and 300 mg lamivudine.</li><li>The other ingredients are microcrystalline cellulose, sodium starch glycolate, magnesium stearate, mannitol (E421), povidone (K29/32), sodium stearyl fumarate, hypromellose (E464), macrogol, titanium dioxide (E171).</li><li>This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree’.</li></ul></div>"         ]       ]     ]
  ], [
     fhir:index 1;
     fhir:Bundle.entry.resource [
       a fhir:Organization;
       fhir:Resource.id [ fhir:value "cfsb1650997423990" ];
       fhir:DomainResource.text [
         fhir:Narrative.status [ fhir:value "generated" ];
         fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Organization</b></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 \"cfsb1650997423990\" </p></div><p><b>identifier</b>: id: ORG-100004538 (OFFICIAL), id: LOC-100000153 (OFFICIAL)</p><p><b>active</b>: true</p><p><b>type</b>: manufacturer <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-CodeSystemUvEPIRrmswi.html\">Referentials Management Services CodeSystem</a>#220000000033)</span></p><p><b>name</b>: GLAXO WELLCOME, S.A.</p><p><b>address</b>: Avda. Extremadura, 3(WORK)</p></div>"       ];
       fhir:Organization.identifier [
         fhir:index 0;
         fhir:Identifier.use [ fhir:value "official" ];
         fhir:Identifier.system [ fhir:value "$spor-org" ];
         fhir:Identifier.value [ fhir:value "ORG-100004538" ]       ], [
         fhir:index 1;
         fhir:Identifier.use [ fhir:value "official" ];
         fhir:Identifier.system [ fhir:value "$spor-org" ];
         fhir:Identifier.value [ fhir:value "LOC-100000153" ]       ];
       fhir:Organization.active [ fhir:value "true"^^xsd:boolean ];
       fhir:Organization.type [
         fhir:index 0;
         fhir:CodeableConcept.coding [
           fhir:index 0;
           fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/rmswi" ];
           fhir:Coding.code [ fhir:value "220000000033" ]         ];
         fhir:CodeableConcept.text [ fhir:value "manufacturer" ]       ];
       fhir:Organization.name [ fhir:value "GLAXO WELLCOME, S.A." ];
       fhir:Organization.address [
         fhir:index 0;
         fhir:Address.use [ fhir:value "work" ];
         fhir:Address.type [ fhir:value "physical" ];
         fhir:Address.text [ fhir:value "Avda. Extremadura, 3" ];
         fhir:Address.line [
           fhir:value "Avda. Extremadura 3, 09400 Aranda De Duero";
           fhir:index 0         ];
         fhir:Address.city [ fhir:value "Aranda De Duero" ];
         fhir:Address.country [ fhir:value "ES" ]       ]     ]
  ], [
     fhir:index 2;
     fhir:Bundle.entry.resource [
       a fhir:Organization;
       fhir:Resource.id [ fhir:value "cfsb1651152112409" ];
       fhir:DomainResource.text [
         fhir:Narrative.status [ fhir:value "generated" ];
         fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Organization</b></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 \"cfsb1651152112409\" </p></div><p><b>identifier</b>: id: ORG-100013412 (OFFICIAL), id: LOC-100020264 (OFFICIAL)</p><p><b>active</b>: true</p><p><b>type</b>: Medicines Regulatory Authority <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#/#220000000032)</span></p><p><b>name</b>: European Medicines Agency</p><p><b>address</b>: Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands(WORK)</p></div>"       ];
       fhir:Organization.identifier [
         fhir:index 0;
         fhir:Identifier.use [ fhir:value "official" ];
         fhir:Identifier.system [ fhir:value "https://spor.ema.europa.eu/omswi" ];
         fhir:Identifier.value [ fhir:value "ORG-100013412" ]       ], [
         fhir:index 1;
         fhir:Identifier.use [ fhir:value "official" ];
         fhir:Identifier.system [ fhir:value "$spor-org" ];
         fhir:Identifier.value [ fhir:value "LOC-100020264" ]       ];
       fhir:Organization.active [ fhir:value "true"^^xsd:boolean ];
       fhir:Organization.type [
         fhir:index 0;
         fhir:CodeableConcept.coding [
           fhir:index 0;
           fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/rmswi/" ];
           fhir:Coding.code [ fhir:value "/#220000000032" ]         ];
         fhir:CodeableConcept.text [ fhir:value "Medicines Regulatory Authority" ]       ];
       fhir:Organization.name [ fhir:value "European Medicines Agency" ];
       fhir:Organization.address [
         fhir:index 0;
         fhir:Address.use [ fhir:value "work" ];
         fhir:Address.type [ fhir:value "physical" ];
         fhir:Address.text [ fhir:value "Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands" ];
         fhir:Address.line [
           fhir:value "Carretera De Martorell 41 61, Poligono Industrial Nord-Est";
           fhir:index 0         ];
         fhir:Address.city [ fhir:value "Amsterdam" ];
         fhir:Address.postalCode [ fhir:value "1083 HS" ];
         fhir:Address.country [ fhir:value "nl" ]       ]     ]
  ], [
     fhir:index 3;
     fhir:Bundle.entry.resource [
       a fhir:Organization;
       fhir:Resource.id [ fhir:value "cfsb1651149636159" ];
       fhir:DomainResource.text [
         fhir:Narrative.status [ fhir:value "generated" ];
         fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Organization</b></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 \"cfsb1651149636159\" </p></div><p><b>identifier</b>: id: ORG-100012958 (OFFICIAL)</p><p><b>active</b>: true</p><p><b>type</b>: Marketing authorisation holder <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-CodeSystemUvEPIRrmswi.html\">Referentials Management Services CodeSystem</a>#220000000034)</span></p><p><b>name</b>: ViiV Healthcare BV</p><p><b>address</b>: Van Asch van Wijckstraat 55H 3811 LP Amersfoort Netherlands(WORK)</p></div>"       ];
       fhir:Organization.identifier [
         fhir:index 0;
         fhir:Identifier.use [ fhir:value "official" ];
         fhir:Identifier.system [ fhir:value "https://spor.ema.europa.eu/omswi" ];
         fhir:Identifier.value [ fhir:value "ORG-100012958" ]       ];
       fhir:Organization.active [ fhir:value "true"^^xsd:boolean ];
       fhir:Organization.type [
         fhir:index 0;
         fhir:CodeableConcept.coding [
           fhir:index 0;
           fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/rmswi" ];
           fhir:Coding.code [ fhir:value "220000000034" ];
           fhir:Coding.display [ fhir:value "Marketing authorisation holder" ]         ];
         fhir:CodeableConcept.text [ fhir:value "Marketing authorisation holder" ]       ];
       fhir:Organization.name [ fhir:value "ViiV Healthcare BV" ];
       fhir:Organization.address [
         fhir:index 0;
         fhir:Address.use [ fhir:value "work" ];
         fhir:Address.type [ fhir:value "physical" ];
         fhir:Address.text [ fhir:value "Van Asch van Wijckstraat 55H 3811 LP Amersfoort Netherlands" ];
         fhir:Address.line [
           fhir:value "Van Asch van Wijckstraat 55H";
           fhir:index 0         ];
         fhir:Address.city [ fhir:value "Amersfoort" ];
         fhir:Address.country [ fhir:value "NL" ]       ]     ]
  ], [
     fhir:index 4;
     fhir:Bundle.entry.resource [
       a fhir:RegulatedAuthorization;
       fhir:Resource.id [ fhir:value "cfsb1651148079894" ];
       fhir:DomainResource.text [
         fhir:Narrative.status [ fhir:value "generated" ];
         fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: RegulatedAuthorization</b></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 \"cfsb1651148079894\" </p></div><p><b>identifier</b>: id: EU/1/19/1370/001 (OFFICIAL)</p><p><b>subject</b>: <a href=\"#MedicinalProductDefinition_cfsb1650904258324\">See above (MedicinalProductDefinition/cfsb1650904258324)</a></p><p><b>type</b>: Marketing Authorisation <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-CodeSystemUvEPIRrmswi.html\">Referentials Management Services CodeSystem</a>#100000072062)</span></p><p><b>region</b>: European Union <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (unknown#eu)</span></p><p><b>status</b>: Active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://build.fhir.org/codesystem-publication-status.html\">PublicationStatus</a>#active)</span></p><p><b>statusDate</b>: 2019-07-01 01:28:17+0000</p><p><b>holder</b>: <a href=\"#Organization_cfsb1651149636159\">See above (Organization/cfsb1651149636159)</a></p><p><b>regulator</b>: <a href=\"#Organization_cfsb1651152112409\">See above (Organization/cfsb1651152112409)</a></p></div>"       ];
       fhir:RegulatedAuthorization.identifier [
         fhir:index 0;
         fhir:Identifier.use [ fhir:value "official" ];
         fhir:Identifier.system [ fhir:value "https://spor.ema.europa.eu/pmswi" ];
         fhir:Identifier.value [ fhir:value "EU/1/19/1370/001" ]       ];
       fhir:RegulatedAuthorization.subject [
         fhir:index 0;
         fhir:Reference.reference [ fhir:value "MedicinalProductDefinition/cfsb1650904258324" ]       ];
       fhir:RegulatedAuthorization.type [
         fhir:CodeableConcept.coding [
           fhir:index 0;
           fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/rmswi" ];
           fhir:Coding.code [ fhir:value "100000072062" ]         ];
         fhir:CodeableConcept.text [ fhir:value "Marketing Authorisation" ]       ];
       fhir:RegulatedAuthorization.region [
         fhir:index 0;
         fhir:CodeableConcept.coding [
           fhir:index 0;
           fhir:Coding.system [ fhir:value "urn:iso:std:iso:3166" ];
           fhir:Coding.code [ fhir:value "eu" ]         ];
         fhir:CodeableConcept.text [ fhir:value "European Union" ]       ];
       fhir:RegulatedAuthorization.status [
         fhir:CodeableConcept.coding [
           fhir:index 0;
           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/publication-status" ];
           fhir:Coding.code [ fhir:value "active" ]         ];
         fhir:CodeableConcept.text [ fhir:value "Active" ]       ];
       fhir:RegulatedAuthorization.statusDate [ fhir:value "2019-07-01T13:28:17Z"^^xsd:dateTime ];
       fhir:RegulatedAuthorization.holder [
         fhir:Reference.reference [ fhir:value "Organization/cfsb1651149636159" ]       ];
       fhir:RegulatedAuthorization.regulator [
         fhir:Reference.reference [ fhir:value "Organization/cfsb1651152112409" ]       ]     ]
  ], [
     fhir:index 5;
     fhir:Bundle.entry.resource [
       a fhir:MedicinalProductDefinition;
       fhir:Resource.id [ fhir:value "cfsb1650904258324" ];
       fhir:DomainResource.text [
         fhir:Narrative.status [ fhir:value "generated" ];
         fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: MedicinalProductDefinition</b></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 \"cfsb1650904258324\" </p></div><p><b>identifier</b>: id: 498163</p><p><b>type</b>: Medicinal Product <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://build.fhir.org/codesystem-medicinal-product-type.html\">MedicinalProductType</a>#MedicinalProduct)</span></p><p><b>domain</b>: Human use <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://build.fhir.org/codesystem-medicinal-product-domain.html\">MedicinalProductDomain</a>#Human)</span></p><p><b>status</b>: Active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://build.fhir.org/codesystem-publication-status.html\">PublicationStatus</a>#active)</span></p><p><b>legalStatusOfSupply</b>: Medicinal product subject to medical prescription <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-CodeSystemUvEPIRrmswi.html\">Referentials Management Services CodeSystem</a>#100000072084)</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Dovato 50 mg/300 mg film-coated tablets</p><p><b>type</b>: Full name <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-CodeSystemUvEPIRrmswi.html\">Referentials Management Services CodeSystem</a>#220000000001)</span></p><h3>NameParts</h3><table class=\"grid\"><tr><td>-</td><td><b>Part</b></td><td><b>Type</b></td></tr><tr><td>*</td><td>film-coated tablets</td><td>Pharmaceutical dose form part <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-CodeSystemUvEPIRrmswi.html\">Referentials Management Services CodeSystem</a>#220000000005)</span></td></tr></table><h3>CountryLanguages</h3><table class=\"grid\"><tr><td>-</td><td><b>Country</b></td><td><b>Jurisdiction</b></td><td><b>Language</b></td></tr><tr><td>*</td><td>European Union <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (unknown#eu)</span></td><td>European Union <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (unknown#eu)</span></td><td>English <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/3.0.0/CodeSystem-v3-ietf3066.html\">Tags for the Identification of Languages</a>#en)</span></td></tr></table></blockquote></div>"       ];
       fhir:MedicinalProductDefinition.identifier [
         fhir:index 0;
         fhir:Identifier.system [ fhir:value "https://spor.ema.europa.eu/pmswi" ];
         fhir:Identifier.value [ fhir:value "498163" ]       ];
       fhir:MedicinalProductDefinition.type [
         fhir:CodeableConcept.coding [
           fhir:index 0;
           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/medicinal-product-type" ];
           fhir:Coding.code [ fhir:value "MedicinalProduct" ]         ];
         fhir:CodeableConcept.text [ fhir:value "Medicinal Product" ]       ];
       fhir:MedicinalProductDefinition.domain [
         fhir:CodeableConcept.coding [
           fhir:index 0;
           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/medicinal-product-domain" ];
           fhir:Coding.code [ fhir:value "Human" ]         ];
         fhir:CodeableConcept.text [ fhir:value "Human use" ]       ];
       fhir:MedicinalProductDefinition.status [
         fhir:CodeableConcept.coding [
           fhir:index 0;
           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/publication-status" ];
           fhir:Coding.code [ fhir:value "active" ];
           fhir:Coding.display [ fhir:value "Active" ]         ]       ];
       fhir:MedicinalProductDefinition.legalStatusOfSupply [
         fhir:CodeableConcept.coding [
           fhir:index 0;
           fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/rmswi" ];
           fhir:Coding.code [ fhir:value "100000072084" ]         ];
         fhir:CodeableConcept.text [ fhir:value "Medicinal product subject to medical prescription" ]       ];
       fhir:MedicinalProductDefinition.name [
         fhir:index 0;
         fhir:MedicinalProductDefinition.name.productName [ fhir:value "Dovato 50 mg/300 mg film-coated tablets" ];
         fhir:MedicinalProductDefinition.name.type [
           fhir:CodeableConcept.coding [
             fhir:index 0;
             fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/rmswi" ];
             fhir:Coding.code [ fhir:value "220000000001" ]           ];
           fhir:CodeableConcept.text [ fhir:value "Full name" ]         ];
         fhir:MedicinalProductDefinition.name.namePart [
           fhir:index 0;
           fhir:MedicinalProductDefinition.name.namePart.part [ fhir:value "film-coated tablets" ];
           fhir:MedicinalProductDefinition.name.namePart.type [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/rmswi" ];
               fhir:Coding.code [ fhir:value "220000000005" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Pharmaceutical dose form part" ]           ]         ];
         fhir:MedicinalProductDefinition.name.countryLanguage [
           fhir:index 0;
           fhir:MedicinalProductDefinition.name.countryLanguage.country [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "urn:iso:std:iso:3166" ];
               fhir:Coding.code [ fhir:value "eu" ]             ];
             fhir:CodeableConcept.text [ fhir:value "European Union" ]           ];
           fhir:MedicinalProductDefinition.name.countryLanguage.jurisdiction [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "urn:iso:std:iso:3166" ];
               fhir:Coding.code [ fhir:value "eu" ]             ];
             fhir:CodeableConcept.text [ fhir:value "European Union" ]           ];
           fhir:MedicinalProductDefinition.name.countryLanguage.language [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "urn:ietf:bcp:47" ];
               fhir:Coding.code [ fhir:value "en" ]             ];
             fhir:CodeableConcept.text [ fhir:value "English" ]           ]         ]       ]     ]
  ], [
     fhir:index 6;
     fhir:Bundle.entry.resource [
       a fhir:PackagedProductDefinition;
       fhir:Resource.id [ fhir:value "cfsb1650995718524" ];
       fhir:DomainResource.text [
         fhir:Narrative.status [ fhir:value "generated" ];
         fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: PackagedProductDefinition</b></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 \"cfsb1650995718524\" </p></div><p><b>identifier</b>: id: EU/1/19/1370/001 (OFFICIAL)</p><p><b>name</b>: Dovato 50 mg/300 mg film-coated tablets</p><p><b>type</b>: Chemical Medicinal Prodcut <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-CodeSystemUvEPIRrmswi.html\">Referentials Management Services CodeSystem</a>#100000155527)</span></p><p><b>packageFor</b>: <a href=\"#MedicinalProductDefinition_cfsb1650904258324\">See above (MedicinalProductDefinition/cfsb1650904258324)</a></p><p><b>status</b>: Active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://build.fhir.org/codesystem-publication-status.html\">PublicationStatus</a>#active)</span></p><p><b>statusDate</b>: 2012-02-07 01:28:17+0000</p><p><b>containedItemQuantity</b>: 30 tablets</p><p><b>manufacturer</b>: <a href=\"#Organization_cfsb1650997423990\">See above (Organization/cfsb1650997423990)</a></p><h3>Packages</h3><table class=\"grid\"><tr><td>-</td><td><b>Identifier</b></td><td><b>Type</b></td><td><b>Quantity</b></td><td><b>Material</b></td></tr><tr><td>*</td><td>id: 654321</td><td>Child-resistant closure <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-CodeSystemUvEPIRrmswi.html\">Referentials Management Services CodeSystem</a>#100000073504)</span></td><td>1</td><td>Cardboard <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-CodeSystemUvEPIRrmswi.html\">Referentials Management Services CodeSystem</a>#200000003529)</span></td></tr></table></div>"       ];
       fhir:PackagedProductDefinition.identifier [
         fhir:index 0;
         fhir:Identifier.use [ fhir:value "official" ];
         fhir:Identifier.system [ fhir:value "$spor-prod" ];
         fhir:Identifier.value [ fhir:value "EU/1/19/1370/001" ]       ];
       fhir:PackagedProductDefinition.name [ fhir:value "Dovato 50 mg/300 mg film-coated tablets" ];
       fhir:PackagedProductDefinition.type [
         fhir:CodeableConcept.coding [
           fhir:index 0;
           fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/rmswi" ];
           fhir:Coding.code [ fhir:value "100000155527" ]         ];
         fhir:CodeableConcept.text [ fhir:value "Chemical Medicinal Prodcut" ]       ];
       fhir:PackagedProductDefinition.packageFor [
         fhir:index 0;
         fhir:Reference.reference [ fhir:value "MedicinalProductDefinition/cfsb1650904258324" ]       ];
       fhir:PackagedProductDefinition.status [
         fhir:CodeableConcept.coding [
           fhir:index 0;
           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/publication-status" ];
           fhir:Coding.code [ fhir:value "active" ];
           fhir:Coding.display [ fhir:value "Active" ]         ]       ];
       fhir:PackagedProductDefinition.statusDate [ fhir:value "2012-02-07T13:28:17Z"^^xsd:dateTime ];
       fhir:PackagedProductDefinition.containedItemQuantity [
         fhir:index 0;
         fhir:Quantity.value [ fhir:value "30"^^xsd:decimal ];
         fhir:Quantity.unit [ fhir:value "tablets" ]       ];
       fhir:PackagedProductDefinition.manufacturer [
         fhir:index 0;
         fhir:Reference.reference [ fhir:value "Organization/cfsb1650997423990" ]       ];
       fhir:PackagedProductDefinition.package [
         fhir:PackagedProductDefinition.package.identifier [
           fhir:index 0;
           fhir:Identifier.system [ fhir:value "https://spor.ema.europa.eu/pmswi" ];
           fhir:Identifier.value [ fhir:value "654321" ]         ];
         fhir:PackagedProductDefinition.package.type [
           fhir:CodeableConcept.coding [
             fhir:index 0;
             fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/rmswi" ];
             fhir:Coding.code [ fhir:value "100000073504" ];
             fhir:Coding.display [ fhir:value "Child-resistant closure" ]           ]         ];
         fhir:PackagedProductDefinition.package.quantity [ fhir:value "1"^^xsd:integer ];
         fhir:PackagedProductDefinition.package.material [
           fhir:index 0;
           fhir:CodeableConcept.coding [
             fhir:index 0;
             fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/rmswi" ];
             fhir:Coding.code [ fhir:value "200000003529" ];
             fhir:Coding.display [ fhir:value "Cardboard" ]           ]         ]       ]     ]
  ], [
     fhir:index 7;
     fhir:Bundle.entry.resource [
       a fhir:AdministrableProductDefinition;
       fhir:Resource.id [ fhir:value "cfsb1650999516847" ];
       fhir:DomainResource.text [
         fhir:Narrative.status [ fhir:value "generated" ];
         fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: AdministrableProductDefinition</b></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 \"cfsb1650999516847\" </p></div><p><b>identifier</b>: id: 123456</p><p><b>status</b>: active</p><p><b>formOf</b>: <a href=\"#MedicinalProductDefinition_cfsb1650904258324\">See above (MedicinalProductDefinition/cfsb1650904258324)</a></p><p><b>administrableDoseForm</b>: Tablet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#10219000)</span></p><p><b>unitOfPresentation</b>: Tablet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#15054000)</span></p><p><b>producedFrom</b>: <a href=\"#ManufacturedItemDefinition_cfsb1650998521654\">See above (ManufacturedItemDefinition/cfsb1650998521654)</a></p><blockquote><p><b>routeOfAdministration</b></p><p><b>code</b>: Oral use <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#20053000)</span></p><h3>TargetSpecies</h3><table class=\"grid\"><tr><td>-</td><td><b>Code</b></td></tr><tr><td>*</td><td>Human <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#/#100000109093)</span></td></tr></table></blockquote></div>"       ];
       fhir:AdministrableProductDefinition.identifier [
         fhir:index 0;
         fhir:Identifier.system [ fhir:value "https://www.who-umc.org/phpid" ];
         fhir:Identifier.value [ fhir:value "123456" ]       ];
       fhir:AdministrableProductDefinition.status [ fhir:value "active" ];
       fhir:AdministrableProductDefinition.formOf [
         fhir:index 0;
         fhir:Reference.reference [ fhir:value "MedicinalProductDefinition/cfsb1650904258324" ]       ];
       fhir:AdministrableProductDefinition.administrableDoseForm [
         fhir:CodeableConcept.coding [
           fhir:index 0;
           fhir:Coding.system [ fhir:value "https://standardterms.edqm.eu/browse/get_concepts_by/SOM/SOM/" ];
           fhir:Coding.code [ fhir:value "10219000" ]         ];
         fhir:CodeableConcept.text [ fhir:value "Tablet" ]       ];
       fhir:AdministrableProductDefinition.unitOfPresentation [
         fhir:CodeableConcept.coding [
           fhir:index 0;
           fhir:Coding.system [ fhir:value "https://standardterms.edqm.eu/browse/get_concepts/UOP/" ];
           fhir:Coding.code [ fhir:value "15054000" ]         ];
         fhir:CodeableConcept.text [ fhir:value "Tablet" ]       ];
       fhir:AdministrableProductDefinition.producedFrom [
         fhir:index 0;
         fhir:Reference.reference [ fhir:value "ManufacturedItemDefinition/cfsb1650998521654" ]       ];
       fhir:AdministrableProductDefinition.routeOfAdministration [
         fhir:index 0;
         fhir:AdministrableProductDefinition.routeOfAdministration.code [
           fhir:CodeableConcept.coding [
             fhir:index 0;
             fhir:Coding.system [ fhir:value "https://standardterms.edqm.eu/browse/get_concepts/ROA/" ];
             fhir:Coding.code [ fhir:value "20053000" ]           ];
           fhir:CodeableConcept.text [ fhir:value "Oral use" ]         ];
         fhir:AdministrableProductDefinition.routeOfAdministration.targetSpecies [
           fhir:index 0;
           fhir:AdministrableProductDefinition.routeOfAdministration.targetSpecies.code [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/rmswi/" ];
               fhir:Coding.code [ fhir:value "/#100000109093" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Human" ]           ]         ]       ]     ]
  ], [
     fhir:index 8;
     fhir:Bundle.entry.resource [
       a fhir:ManufacturedItemDefinition;
       fhir:Resource.id [ fhir:value "cfsb1650998521654" ];
       fhir:DomainResource.text [
         fhir:Narrative.status [ fhir:value "generated" ];
         fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ManufacturedItemDefinition</b></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 \"cfsb1650998521654\" </p></div><p><b>identifier</b>: id: EU/1/19/1370/001 (OFFICIAL)</p><p><b>status</b>: active</p><p><b>manufacturedDoseForm</b>: Film-coated tablet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#100000073665)</span></p><p><b>unitOfPresentation</b>: Tablet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-CodeSystemUvEPIRrmswi.html\">Referentials Management Services CodeSystem</a>#200000002152)</span></p><p><b>manufacturer</b>: <a href=\"#Organization_cfsb1650997423990\">See above (Organization/cfsb1650997423990)</a></p></div>"       ];
       fhir:ManufacturedItemDefinition.identifier [
         fhir:index 0;
         fhir:Identifier.use [ fhir:value "official" ];
         fhir:Identifier.system [ fhir:value "https://spor.ema.europa.eu/pmswi/#/" ];
         fhir:Identifier.value [ fhir:value "EU/1/19/1370/001" ]       ];
       fhir:ManufacturedItemDefinition.status [ fhir:value "active" ];
       fhir:ManufacturedItemDefinition.manufacturedDoseForm [
         fhir:CodeableConcept.coding [
           fhir:index 0;
           fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/rmswi/" ];
           fhir:Coding.code [ fhir:value "100000073665" ]         ];
         fhir:CodeableConcept.text [ fhir:value "Film-coated tablet" ]       ];
       fhir:ManufacturedItemDefinition.unitOfPresentation [
         fhir:CodeableConcept.coding [
           fhir:index 0;
           fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/rmswi" ];
           fhir:Coding.code [ fhir:value "200000002152" ]         ];
         fhir:CodeableConcept.text [ fhir:value "Tablet" ]       ];
       fhir:ManufacturedItemDefinition.manufacturer [
         fhir:index 0;
         fhir:Reference.reference [ fhir:value "Organization/cfsb1650997423990" ]       ]     ]
  ], [
     fhir:index 9;
     fhir:Bundle.entry.resource [
       a fhir:Ingredient;
       fhir:Resource.id [ fhir:value "cfsb1651162710491" ];
       fhir:DomainResource.text [
         fhir:Narrative.status [ fhir:value "generated" ];
         fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Ingredient</b></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 \"cfsb1651162710491\" </p></div><p><b>identifier</b>: id: 1Q1V9V5WYQ (OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: <a href=\"#ManufacturedItemDefinition_cfsb1650998521654\">See above (ManufacturedItemDefinition/cfsb1650998521654)</a></p><p><b>role</b>: active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#00000072072)</span></p><h3>Manufacturers</h3><table class=\"grid\"><tr><td>-</td><td><b>Manufacturer</b></td></tr><tr><td>*</td><td><a href=\"#Organization_cfsb1650997423990\">See above (Organization/cfsb1650997423990)</a></td></tr></table><blockquote><p><b>substance</b></p><h3>Strengths</h3><table class=\"grid\"><tr><td>-</td><td><b>Presentation[x]</b></td><td><b>Basis</b></td></tr><tr><td>*</td><td>50 mg</td><td>active ingredient - basis of strength <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (v3-RoleClassIngredientEntity##ACTIB)</span></td></tr></table></blockquote></div>"       ];
       fhir:Ingredient.identifier [
         fhir:Identifier.use [ fhir:value "official" ];
         fhir:Identifier.system [ fhir:value "https://gsrs.ncats.nih.gov/ginas/app/beta/" ];
         fhir:Identifier.value [ fhir:value "1Q1V9V5WYQ" ]       ];
       fhir:Ingredient.status [ fhir:value "active" ];
       fhir:Ingredient.for [
         fhir:index 0;
         fhir:Reference.reference [ fhir:value "ManufacturedItemDefinition/cfsb1650998521654" ]       ];
       fhir:Ingredient.role [
         fhir:CodeableConcept.coding [
           fhir:index 0;
           fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/rmswi/" ];
           fhir:Coding.code [ fhir:value "00000072072" ]         ];
         fhir:CodeableConcept.text [ fhir:value "active" ]       ];
       fhir:Ingredient.manufacturer [
         fhir:index 0;
         fhir:Ingredient.manufacturer.manufacturer [
           fhir:Reference.reference [ fhir:value "Organization/cfsb1650997423990" ]         ]       ];
       fhir:Ingredient.substance [
         fhir:Ingredient.substance.code [
           fhir:CodeableReference.concept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "https://gsrs.ncats.nih.gov/ginas/app/beta/" ];
               fhir:Coding.code [ fhir:value "1Q1V9V5WYQ" ];
               fhir:Coding.display [ fhir:value "DOLUTEGRAVIR SODIUM" ]             ]           ]         ];
         fhir:Ingredient.substance.strength [
           fhir:index 0;
           fhir:Ingredient.substance.strength.presentationQuantity [
             fhir:Quantity.value [ fhir:value "50"^^xsd:decimal ];
             fhir:Quantity.unit [ fhir:value "mg" ]           ];
           fhir:Ingredient.substance.strength.basis [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://terminology.hl7.org/ValueSet/v3-RoleClassIngredientEntity" ];
               fhir:Coding.code [ fhir:value "#ACTIB" ]             ];
             fhir:CodeableConcept.text [ fhir:value "active ingredient - basis of strength" ]           ]         ]       ]     ]
  ], [
     fhir:index 10;
     fhir:Bundle.entry.resource [
       a fhir:Ingredient;
       fhir:Resource.id [ fhir:value "cfsb1651164758053" ];
       fhir:DomainResource.text [
         fhir:Narrative.status [ fhir:value "generated" ];
         fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Ingredient</b></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 \"cfsb1651164758053\" </p></div><p><b>identifier</b>: id: 2T8Q726O95 (OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: <a href=\"#ManufacturedItemDefinition_cfsb1650998521654\">See above (ManufacturedItemDefinition/cfsb1650998521654)</a></p><p><b>role</b>: active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#100000072072)</span></p><h3>Manufacturers</h3><table class=\"grid\"><tr><td>-</td><td><b>Manufacturer</b></td></tr><tr><td>*</td><td><a href=\"#Organization_cfsb1650997423990\">See above (Organization/cfsb1650997423990)</a></td></tr></table><blockquote><p><b>substance</b></p><h3>Strengths</h3><table class=\"grid\"><tr><td>-</td><td><b>Presentation[x]</b></td><td><b>Basis</b></td></tr><tr><td>*</td><td>300 mg</td><td>active ingredient - basis of strength <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (v3-RoleClassIngredientEntity##ACTIB)</span></td></tr></table></blockquote></div>"       ];
       fhir:Ingredient.identifier [
         fhir:Identifier.use [ fhir:value "official" ];
         fhir:Identifier.system [ fhir:value "https://gsrs.ncats.nih.gov/ginas/app/beta/" ];
         fhir:Identifier.value [ fhir:value "2T8Q726O95" ]       ];
       fhir:Ingredient.status [ fhir:value "active" ];
       fhir:Ingredient.for [
         fhir:index 0;
         fhir:Reference.reference [ fhir:value "ManufacturedItemDefinition/cfsb1650998521654" ]       ];
       fhir:Ingredient.role [
         fhir:CodeableConcept.coding [
           fhir:index 0;
           fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/rmswi/" ];
           fhir:Coding.code [ fhir:value "100000072072" ]         ];
         fhir:CodeableConcept.text [ fhir:value "active" ]       ];
       fhir:Ingredient.manufacturer [
         fhir:index 0;
         fhir:Ingredient.manufacturer.manufacturer [
           fhir:Reference.reference [ fhir:value "Organization/cfsb1650997423990" ]         ]       ];
       fhir:Ingredient.substance [
         fhir:Ingredient.substance.code [
           fhir:CodeableReference.concept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "https://gsrs.ncats.nih.gov/ginas/app/beta/" ];
               fhir:Coding.code [ fhir:value "2T8Q726O95" ];
               fhir:Coding.display [ fhir:value "lamivudine" ]             ]           ]         ];
         fhir:Ingredient.substance.strength [
           fhir:index 0;
           fhir:Ingredient.substance.strength.presentationQuantity [
             fhir:Quantity.value [ fhir:value "300"^^xsd:decimal ];
             fhir:Quantity.unit [ fhir:value "mg" ]           ];
           fhir:Ingredient.substance.strength.basis [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://terminology.hl7.org/ValueSet/v3-RoleClassIngredientEntity" ];
               fhir:Coding.code [ fhir:value "#ACTIB" ]             ];
             fhir:CodeableConcept.text [ fhir:value "active ingredient - basis of strength" ]           ]         ]       ]     ]
  ], [
     fhir:index 11;
     fhir:Bundle.entry.resource [
       a fhir:Ingredient;
       fhir:Resource.id [ fhir:value "cfsb1651170791283" ];
       fhir:DomainResource.text [
         fhir:Narrative.status [ fhir:value "generated" ];
         fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Ingredient</b></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 \"cfsb1651170791283\" </p></div><p><b>identifier</b>: id: OP1R32D61U (OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: <a href=\"#ManufacturedItemDefinition_cfsb1650998521654\">See above (ManufacturedItemDefinition/cfsb1650998521654)</a></p><p><b>role</b>: Excipient <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#100000072082)</span></p><h3>Manufacturers</h3><table class=\"grid\"><tr><td>-</td><td><b>Manufacturer</b></td></tr><tr><td>*</td><td><a href=\"#Organization_cfsb1650997423990\">See above (Organization/cfsb1650997423990)</a></td></tr></table><blockquote><p><b>substance</b></p></blockquote></div>"       ];
       fhir:Ingredient.identifier [
         fhir:Identifier.use [ fhir:value "official" ];
         fhir:Identifier.system [ fhir:value "https://gsrs.ncats.nih.gov/ginas/app/beta/" ];
         fhir:Identifier.value [ fhir:value "OP1R32D61U" ]       ];
       fhir:Ingredient.status [ fhir:value "active" ];
       fhir:Ingredient.for [
         fhir:index 0;
         fhir:Reference.reference [ fhir:value "ManufacturedItemDefinition/cfsb1650998521654" ]       ];
       fhir:Ingredient.role [
         fhir:CodeableConcept.coding [
           fhir:index 0;
           fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/rmswi/" ];
           fhir:Coding.code [ fhir:value "100000072082" ]         ];
         fhir:CodeableConcept.text [ fhir:value "Excipient" ]       ];
       fhir:Ingredient.manufacturer [
         fhir:index 0;
         fhir:Ingredient.manufacturer.manufacturer [
           fhir:Reference.reference [ fhir:value "Organization/cfsb1650997423990" ]         ]       ];
       fhir:Ingredient.substance [
         fhir:Ingredient.substance.code [
           fhir:CodeableReference.concept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "https://gsrs.ncats.nih.gov/ginas/app/beta/" ];
               fhir:Coding.code [ fhir:value "OP1R32D61U" ];
               fhir:Coding.display [ fhir:value "microcrystalline cellulose" ]             ]           ]         ]       ]     ]
  ], [
     fhir:index 12;
     fhir:Bundle.entry.resource [
       a fhir:Ingredient;
       fhir:Resource.id [ fhir:value "cfsb1651229974487" ];
       fhir:DomainResource.text [
         fhir:Narrative.status [ fhir:value "generated" ];
         fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Ingredient</b></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 \"cfsb1651229974487\" </p></div><p><b>identifier</b>: id: H8AV0SQX4D (OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: <a href=\"#ManufacturedItemDefinition_cfsb1650998521654\">See above (ManufacturedItemDefinition/cfsb1650998521654)</a></p><p><b>role</b>: Excipient <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#100000072082)</span></p><h3>Manufacturers</h3><table class=\"grid\"><tr><td>-</td><td><b>Manufacturer</b></td></tr><tr><td>*</td><td><a href=\"#Organization_cfsb1650997423990\">See above (Organization/cfsb1650997423990)</a></td></tr></table><blockquote><p><b>substance</b></p></blockquote></div>"       ];
       fhir:Ingredient.identifier [
         fhir:Identifier.use [ fhir:value "official" ];
         fhir:Identifier.system [ fhir:value "https://gsrs.ncats.nih.gov/ginas/app/beta/" ];
         fhir:Identifier.value [ fhir:value "H8AV0SQX4D" ]       ];
       fhir:Ingredient.status [ fhir:value "active" ];
       fhir:Ingredient.for [
         fhir:index 0;
         fhir:Reference.reference [ fhir:value "ManufacturedItemDefinition/cfsb1650998521654" ]       ];
       fhir:Ingredient.role [
         fhir:CodeableConcept.coding [
           fhir:index 0;
           fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/rmswi/" ];
           fhir:Coding.code [ fhir:value "100000072082" ]         ];
         fhir:CodeableConcept.text [ fhir:value "Excipient" ]       ];
       fhir:Ingredient.manufacturer [
         fhir:index 0;
         fhir:Ingredient.manufacturer.manufacturer [
           fhir:Reference.reference [ fhir:value "Organization/cfsb1650997423990" ]         ]       ];
       fhir:Ingredient.substance [
         fhir:Ingredient.substance.code [
           fhir:CodeableReference.concept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "https://gsrs.ncats.nih.gov/ginas/app/beta/" ];
               fhir:Coding.code [ fhir:value "H8AV0SQX4D" ];
               fhir:Coding.display [ fhir:value "sodium starch glycolate" ]             ]           ]         ]       ]     ]
  ], [
     fhir:index 13;
     fhir:Bundle.entry.resource [
       a fhir:Ingredient;
       fhir:Resource.id [ fhir:value "cfsb1651230170831" ];
       fhir:DomainResource.text [
         fhir:Narrative.status [ fhir:value "generated" ];
         fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Ingredient</b></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 \"cfsb1651230170831\" </p></div><p><b>identifier</b>: id: 70097M6I30 (OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: <a href=\"#ManufacturedItemDefinition_cfsb1650998521654\">See above (ManufacturedItemDefinition/cfsb1650998521654)</a></p><p><b>role</b>: Excipient <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#100000072082)</span></p><h3>Manufacturers</h3><table class=\"grid\"><tr><td>-</td><td><b>Manufacturer</b></td></tr><tr><td>*</td><td><a href=\"#Organization_cfsb1650997423990\">See above (Organization/cfsb1650997423990)</a></td></tr></table><blockquote><p><b>substance</b></p></blockquote></div>"       ];
       fhir:Ingredient.identifier [
         fhir:Identifier.use [ fhir:value "official" ];
         fhir:Identifier.system [ fhir:value "https://gsrs.ncats.nih.gov/ginas/app/beta/" ];
         fhir:Identifier.value [ fhir:value "70097M6I30" ]       ];
       fhir:Ingredient.status [ fhir:value "active" ];
       fhir:Ingredient.for [
         fhir:index 0;
         fhir:Reference.reference [ fhir:value "ManufacturedItemDefinition/cfsb1650998521654" ]       ];
       fhir:Ingredient.role [
         fhir:CodeableConcept.coding [
           fhir:index 0;
           fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/rmswi/" ];
           fhir:Coding.code [ fhir:value "100000072082" ]         ];
         fhir:CodeableConcept.text [ fhir:value "Excipient" ]       ];
       fhir:Ingredient.manufacturer [
         fhir:index 0;
         fhir:Ingredient.manufacturer.manufacturer [
           fhir:Reference.reference [ fhir:value "Organization/cfsb1650997423990" ]         ]       ];
       fhir:Ingredient.substance [
         fhir:Ingredient.substance.code [
           fhir:CodeableReference.concept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "https://gsrs.ncats.nih.gov/ginas/app/beta/" ];
               fhir:Coding.code [ fhir:value "70097M6I30" ];
               fhir:Coding.display [ fhir:value "magnesium stearate" ]             ]           ]         ]       ]     ]
  ], [
     fhir:index 14;
     fhir:Bundle.entry.resource [
       a fhir:Ingredient;
       fhir:Resource.id [ fhir:value "cfsb1651230330246" ];
       fhir:DomainResource.text [
         fhir:Narrative.status [ fhir:value "generated" ];
         fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Ingredient</b></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 \"cfsb1651230330246\" </p></div><p><b>identifier</b>: id: 3OWL53L36A (OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: <a href=\"#ManufacturedItemDefinition_cfsb1650998521654\">See above (ManufacturedItemDefinition/cfsb1650998521654)</a></p><p><b>role</b>: Excipient <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#100000072082)</span></p><h3>Manufacturers</h3><table class=\"grid\"><tr><td>-</td><td><b>Manufacturer</b></td></tr><tr><td>*</td><td><a href=\"#Organization_cfsb1650997423990\">See above (Organization/cfsb1650997423990)</a></td></tr></table><blockquote><p><b>substance</b></p></blockquote></div>"       ];
       fhir:Ingredient.identifier [
         fhir:Identifier.use [ fhir:value "official" ];
         fhir:Identifier.system [ fhir:value "https://gsrs.ncats.nih.gov/ginas/app/beta/" ];
         fhir:Identifier.value [ fhir:value "3OWL53L36A" ]       ];
       fhir:Ingredient.status [ fhir:value "active" ];
       fhir:Ingredient.for [
         fhir:index 0;
         fhir:Reference.reference [ fhir:value "ManufacturedItemDefinition/cfsb1650998521654" ]       ];
       fhir:Ingredient.role [
         fhir:CodeableConcept.coding [
           fhir:index 0;
           fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/rmswi/" ];
           fhir:Coding.code [ fhir:value "100000072082" ]         ];
         fhir:CodeableConcept.text [ fhir:value "Excipient" ]       ];
       fhir:Ingredient.manufacturer [
         fhir:index 0;
         fhir:Ingredient.manufacturer.manufacturer [
           fhir:Reference.reference [ fhir:value "Organization/cfsb1650997423990" ]         ]       ];
       fhir:Ingredient.substance [
         fhir:Ingredient.substance.code [
           fhir:CodeableReference.concept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "https://gsrs.ncats.nih.gov/ginas/app/beta/" ];
               fhir:Coding.code [ fhir:value "3OWL53L36A" ];
               fhir:Coding.display [ fhir:value "mannitol" ]             ]           ]         ]       ]     ]
  ].

# - ontology header ------------------------------------------------------------

 a owl:Ontology;
  owl:imports fhir:fhir.ttl.