Bundle Japan JA - Package Insert for Simvastatin 20 mg tablets - TTL Representation - Gravitate Health FHIR Implementation Guide v0.1.0

Gravitate Health FHIR Implementation Guide, published by Gravitate Health Project. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/gravitate-health/ and changes regularly. See the Directory of published versions
: Bundle Japan JA - Package Insert for Simvastatin 20 mg tablets - TTL Representation

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@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:id [ fhir:v "bundlejpisimvastatin20"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi>     ] )
  ] ; # 
  fhir:language [ fhir:v "ja"] ; # 
  fhir:identifier [
fhir:system [ fhir:v "https://www.pmda.jp/"^^xsd:anyURI ] ;
fhir:value [ fhir:v "jpiplaceholder" ]
  ] ; # 
  fhir:type [ fhir:v "document"] ; # 
  fhir:timestamp [ fhir:v "2002-08-01T13:28:17Z"^^xsd:dateTime] ; # 
  fhir:entry ( [
fhir:fullUrl [ fhir:v "http://hl7.eu/fhir/ig/gravitate-health/Composition/compositionsimvastatin20jpi"^^xsd:anyURI ] ;
    ( fhir:resource <http://hl7.eu/fhir/ig/gravitate-health/Composition/compositionsimvastatin20jpi> )
  ] [
fhir:fullUrl [ fhir:v "http://hl7.eu/fhir/ig/gravitate-health/Organization/orgohara"^^xsd:anyURI ] ;
    ( fhir:resource <http://hl7.eu/fhir/ig/gravitate-health/Organization/orgohara> )
  ] [
fhir:fullUrl [ fhir:v "http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/authsimvastatin20"^^xsd:anyURI ] ;
    ( fhir:resource <http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/authsimvastatin20> )
  ] [
fhir:fullUrl [ fhir:v "http://hl7.eu/fhir/ig/gravitate-health/MedicinalProductDefinition/medprodsimvastatin20"^^xsd:anyURI ] ;
    ( fhir:resource <http://hl7.eu/fhir/ig/gravitate-health/MedicinalProductDefinition/medprodsimvastatin20> )
  ] [
fhir:fullUrl [ fhir:v "http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/packsimvastatin20"^^xsd:anyURI ] ;
    ( fhir:resource <http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/packsimvastatin20> )
  ] [
fhir:fullUrl [ fhir:v "http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/adminprodsimvastatin20"^^xsd:anyURI ] ;
    ( fhir:resource <http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/adminprodsimvastatin20> )
  ] [
fhir:fullUrl [ fhir:v "http://hl7.eu/fhir/ig/gravitate-health/ManufacturedItemDefinition/manitemsimvastatin20"^^xsd:anyURI ] ;
    ( fhir:resource <http://hl7.eu/fhir/ig/gravitate-health/ManufacturedItemDefinition/manitemsimvastatin20> )
  ] [
fhir:fullUrl [ fhir:v "http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredientsimvastatin20"^^xsd:anyURI ] ;
    ( fhir:resource <http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredientsimvastatin20> )
  ] [
fhir:fullUrl [ fhir:v "http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/subsimvastatin20"^^xsd:anyURI ] ;
    ( fhir:resource <http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/subsimvastatin20> )
  ] ) . # 

<http://hl7.eu/fhir/ig/gravitate-health/Composition/compositionsimvastatin20jpi> a fhir:Composition ;
  fhir:id [ fhir:v "compositionsimvastatin20jpi"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi>     ] )
  ] ; # 
  fhir:language [ fhir:v "ja"] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"ja\" lang=\"ja\"><a name=\"Composition_compositionsimvastatin20jpi\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition compositionsimvastatin20jpi</b></p><a name=\"compositionsimvastatin20jpi\"> </a><a name=\"hccompositionsimvastatin20jpi\"> </a><a name=\"compositionsimvastatin20jpi-en-US\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Language: ja</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Composition-uv-epi.html\">Composition (ePI)</a></p></div><p><b>identifier</b>: <code>https://spor.ema.europa.eu/rmswi/</code>/fcats34placeholder</p><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/ 100000155538}\">Package Leaflet</span></p><p><b>date</b>: 2002-08-01 13:28:17+0000</p><p><b>author</b>: <a href=\"Organization-orgohara.html\">Organization Ohara Pharmaceutical Co., Ltd.</a></p><p><b>title</b>: simvastatin20 Package Leaflet - 150 mg for Intravenous Use</p><h3>Attesters</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Mode</b></td><td><b>Time</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://hl7.org/fhir/composition-attestation-mode official}\">Official</span></td><td>2002-08-01 13:28:17+0000</td></tr></table></div>"
  ] ; # 
  fhir:identifier ( [
fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ;
fhir:value [ fhir:v "fcats34placeholder" ]
  ] ) ; # 
  fhir:status [ fhir:v "final"] ; # 
  fhir:type [
    ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "100000155538" ]     ] ) ;
fhir:text [ fhir:v "Package Leaflet" ]
  ] ; # 
  fhir:subject ( [
fhir:reference [ fhir:v "MedicinalProductDefinition/medprodsimvastatin20" ]
  ] ) ; # 
  fhir:date [ fhir:v "2002-08-01T13:28:17Z"^^xsd:dateTime] ; # 
  fhir:author ( [
fhir:reference [ fhir:v "Organization/orgohara" ]
  ] ) ; # 
  fhir:title [ fhir:v "simvastatin20 Package Leaflet - 150 mg for Intravenous Use"] ; # 
  fhir:attester ( [
fhir:mode [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/composition-attestation-mode"^^xsd:anyURI ] ;
fhir:code [ fhir:v "official" ]       ] )     ] ;
fhir:time [ fhir:v "2002-08-01T13:28:17Z"^^xsd:dateTime ]
  ] ) ; # 
  fhir:section ( [
fhir:title [ fhir:v "アロマターゼ阻害剤/閉経後乳癌治療剤" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "0" ]       ] ) ;
fhir:text [ fhir:v "アロマターゼ阻害剤/閉経後乳癌治療剤" ]     ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"     ]
  ] [
fhir:title [ fhir:v "1. 警告" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "1" ]       ] ) ;
fhir:text [ fhir:v "1. 警告" ]     ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"     ] ;
fhir:emptyReason [
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]       ] )     ] ;
    ( fhir:section [
fhir:title [ fhir:v "1.1" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "2.1" ]         ] ) ;
fhir:text [ fhir:v "1.1" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"       ] ;
fhir:emptyReason [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]         ] )       ]     ] [
fhir:title [ fhir:v "1.2" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "2.1" ]         ] ) ;
fhir:text [ fhir:v "1.2" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"       ] ;
fhir:emptyReason [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]         ] )       ]     ] [
fhir:title [ fhir:v "1.3" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "2.1" ]         ] ) ;
fhir:text [ fhir:v "1.3" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"       ] ;
fhir:emptyReason [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]         ] )       ]     ] )
  ] [
fhir:title [ fhir:v "2. 禁忌(次の患者には投与しないこと)" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "2" ]       ] ) ;
fhir:text [ fhir:v "禁忌(次の患者には投与しないこと)" ]     ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"     ] ;
fhir:emptyReason [
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]       ] )     ] ;
    ( fhir:section [
fhir:title [ fhir:v "2.1" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "2.1" ]         ] ) ;
fhir:text [ fhir:v "2.1" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"       ] ;
fhir:emptyReason [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]         ] )       ]     ] [
fhir:title [ fhir:v "2.2" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "2.2" ]         ] ) ;
fhir:text [ fhir:v "2.2" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"       ] ;
fhir:emptyReason [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]         ] )       ]     ] [
fhir:title [ fhir:v "2.3" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "2.3" ]         ] ) ;
fhir:text [ fhir:v "2.3" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"       ] ;
fhir:emptyReason [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]         ] )       ]     ] )
  ] [
fhir:title [ fhir:v "3. 組成・性状" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "3" ]       ] ) ;
fhir:text [ fhir:v "3. 組成・性状" ]     ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"     ] ;
fhir:emptyReason [
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]       ] )     ] ;
    ( fhir:section [
fhir:title [ fhir:v "3.1 組成" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "3.1" ]         ] ) ;
fhir:text [ fhir:v "3.1 組成" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"       ] ;
fhir:emptyReason [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]         ] )       ]     ] [
fhir:title [ fhir:v "3.2 製剤の性状" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "3.2" ]         ] ) ;
fhir:text [ fhir:v "3.2 製剤の性状" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"       ] ;
fhir:emptyReason [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]         ] )       ]     ] )
  ] [
fhir:title [ fhir:v "4. 効能又は効果" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "4" ]       ] ) ;
fhir:text [ fhir:v "効能又は効果" ]     ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"     ] ;
fhir:emptyReason [
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]       ] )     ]
  ] [
fhir:title [ fhir:v "5. 効能又は効果に関連する注意" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "5" ]       ] ) ;
fhir:text [ fhir:v "効能又は効果に関連する注意" ]     ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"     ] ;
fhir:emptyReason [
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]       ] )     ]
  ] [
fhir:title [ fhir:v "6. 用法及び用量" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "6" ]       ] ) ;
fhir:text [ fhir:v "用法及び用量" ]     ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"     ] ;
fhir:emptyReason [
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]       ] )     ]
  ] [
fhir:title [ fhir:v "7. 用法及び用量に関連する注意" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "7" ]       ] ) ;
fhir:text [ fhir:v "7. 用法及び用量に関連する注意" ]     ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"     ] ;
fhir:emptyReason [
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]       ] )     ]
  ] [
fhir:title [ fhir:v "8. 重要な基本的注意" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "8" ]       ] ) ;
fhir:text [ fhir:v "重要な基本的注意" ]     ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"     ] ;
fhir:emptyReason [
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]       ] )     ] ;
    ( fhir:section [
fhir:title [ fhir:v "8.1" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "8.1" ]         ] ) ;
fhir:text [ fhir:v "8.1" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"       ] ;
fhir:emptyReason [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]         ] )       ]     ] [
fhir:title [ fhir:v "8.2" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "8.2" ]         ] ) ;
fhir:text [ fhir:v "8.2" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"       ] ;
fhir:emptyReason [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]         ] )       ]     ] [
fhir:title [ fhir:v "8.3" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "8.3" ]         ] ) ;
fhir:text [ fhir:v "8.3" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"       ] ;
fhir:emptyReason [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]         ] )       ]     ] [
fhir:title [ fhir:v "8.4" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "8.4" ]         ] ) ;
fhir:text [ fhir:v "8.4" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"       ] ;
fhir:emptyReason [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]         ] )       ]     ] )
  ] [
fhir:title [ fhir:v "9. 特定の背景を有する患者に関する注意" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "9" ]       ] ) ;
fhir:text [ fhir:v "特定の背景を有する患者に関する注意" ]     ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"     ] ;
fhir:emptyReason [
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]       ] )     ] ;
    ( fhir:section [
fhir:title [ fhir:v "9.1" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "9.2" ]         ] ) ;
fhir:text [ fhir:v "9.1" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"       ] ;
fhir:emptyReason [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]         ] )       ]     ] [
fhir:title [ fhir:v "9.2 腎機能障害患者" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "9.2" ]         ] ) ;
fhir:text [ fhir:v "9.2 腎機能障害患者" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"       ] ;
fhir:emptyReason [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]         ] )       ] ;
      ( fhir:section [
fhir:title [ fhir:v "9.2.1 重度の腎障害のある患者" ] ;
fhir:code [
          ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "9" ]           ] ) ;
fhir:text [ fhir:v "9.2.1 重度の腎障害のある患者" ]         ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"         ] ;
fhir:emptyReason [
          ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]           ] )         ]       ] )     ] [
fhir:title [ fhir:v "9.3 肝機能障害患者" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "9.3" ]         ] ) ;
fhir:text [ fhir:v "9.3 肝機能障害患者" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"       ] ;
fhir:emptyReason [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]         ] )       ] ;
      ( fhir:section [
fhir:title [ fhir:v "9.3.1 重度の肝障害のある患者" ] ;
fhir:code [
          ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "9.3.1" ]           ] ) ;
fhir:text [ fhir:v "9.3.1 重度の肝障害のある患者" ]         ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"         ] ;
fhir:emptyReason [
          ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]           ] )         ]       ] )     ] [
fhir:title [ fhir:v "9.4" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "9.4" ]         ] ) ;
fhir:text [ fhir:v "9.4" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"       ] ;
fhir:emptyReason [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]         ] )       ]     ] [
fhir:title [ fhir:v "9.5 妊婦" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "9" ]         ] ) ;
fhir:text [ fhir:v "9.5 妊婦" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"       ] ;
fhir:emptyReason [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]         ] )       ]     ] [
fhir:title [ fhir:v "9.6 授乳婦" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "9.6" ]         ] ) ;
fhir:text [ fhir:v "9.6 授乳婦" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"       ]     ] )
  ] [
fhir:title [ fhir:v "10. 相互作用" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "10" ]       ] ) ;
fhir:text [ fhir:v "10. 相互作用" ]     ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"     ] ;
fhir:emptyReason [
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]       ] )     ] ;
    ( fhir:section [
fhir:title [ fhir:v "10.1" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "9" ]         ] ) ;
fhir:text [ fhir:v "10.1" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"       ] ;
fhir:emptyReason [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]         ] )       ]     ] [
fhir:title [ fhir:v "10.2 併用注意(併用に注意すること)" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "10" ]         ] ) ;
fhir:text [ fhir:v "10.2 併用注意(併用に注意すること)" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"       ] ;
fhir:emptyReason [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]         ] )       ]     ] )
  ] [
fhir:title [ fhir:v "11. 副作用" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "11" ]       ] ) ;
fhir:text [ fhir:v "11. 副作用" ]     ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"     ] ;
    ( fhir:section [
fhir:title [ fhir:v "11.1 重大な副作用" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "11.1" ]         ] ) ;
fhir:text [ fhir:v "11.1 重大な副作用" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"       ] ;
fhir:emptyReason [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]         ] )       ] ;
      ( fhir:section [
fhir:title [ fhir:v "11.1.1" ] ;
fhir:code [
          ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "11.1.1" ]           ] ) ;
fhir:text [ fhir:v "11.1.1" ]         ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"         ] ;
fhir:emptyReason [
          ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]           ] )         ]       ] )     ] [
fhir:title [ fhir:v "11.2 その他の副作用" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "11.2" ]         ] ) ;
fhir:text [ fhir:v "11.2 その他の副作用" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"       ] ;
fhir:emptyReason [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]         ] )       ]     ] )
  ] [
fhir:title [ fhir:v "12. 臨床検査結果に及ぼす影響" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "12" ]       ] ) ;
fhir:text [ fhir:v "12. 臨床検査結果に及ぼす影響" ]     ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"     ]
  ] [
fhir:title [ fhir:v "13. 過量投与" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "13" ]       ] ) ;
fhir:text [ fhir:v "13. 過量投与" ]     ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"     ] ;
fhir:emptyReason [
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]       ] )     ]
  ] [
fhir:title [ fhir:v "14. 適用上の注意" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "14" ]       ] ) ;
fhir:text [ fhir:v "14. 適用上の注意" ]     ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"     ] ;
fhir:emptyReason [
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]       ] )     ] ;
    ( fhir:section [
fhir:title [ fhir:v "14.1 薬剤交付時の注意" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "14.1" ]         ] ) ;
fhir:text [ fhir:v "14.1 薬剤交付時の注意" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"       ] ;
fhir:emptyReason [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]         ] )       ]     ] )
  ] [
fhir:title [ fhir:v "15. その他の注意" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "13" ]       ] ) ;
fhir:text [ fhir:v "15. その他の注意" ]     ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"     ] ;
fhir:emptyReason [
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]       ] )     ] ;
    ( fhir:section [
fhir:title [ fhir:v "15.1" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "13" ]         ] ) ;
fhir:text [ fhir:v "15.1" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"       ] ;
fhir:emptyReason [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]         ] )       ]     ] [
fhir:title [ fhir:v "15.2 非臨床試験に基づく情報" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "13" ]         ] ) ;
fhir:text [ fhir:v "15.2 非臨床試験に基づく情報" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"       ] ;
fhir:emptyReason [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]         ] )       ]     ] )
  ] [
fhir:title [ fhir:v "16. 薬物動態" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "13" ]       ] ) ;
fhir:text [ fhir:v "16. 薬物動態" ]     ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"     ] ;
    ( fhir:section [
fhir:title [ fhir:v "16.1 血中濃度" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "13" ]         ] ) ;
fhir:text [ fhir:v "16.1 血中濃度" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"       ] ;
fhir:emptyReason [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]         ] )       ]     ] [
fhir:title [ fhir:v "16.2 吸収" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "13" ]         ] ) ;
fhir:text [ fhir:v "16.2 吸収" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"       ] ;
fhir:emptyReason [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]         ] )       ] ;
      ( fhir:section [
fhir:title [ fhir:v "16.2.1 食事の影響" ] ;
fhir:code [
          ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "13" ]           ] ) ;
fhir:text [ fhir:v "16.2.1 食事の影響" ]         ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"         ] ;
fhir:emptyReason [
          ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]           ] )         ]       ] )     ] [
fhir:title [ fhir:v "16.3 分布" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "13" ]         ] ) ;
fhir:text [ fhir:v "16.3 分布" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"       ] ;
fhir:emptyReason [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]         ] )       ] ;
      ( fhir:section [
fhir:title [ fhir:v "16.3.1 組織内濃度" ] ;
fhir:code [
          ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "13" ]           ] ) ;
fhir:text [ fhir:v "16.3.1 組織内濃度" ]         ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"         ] ;
fhir:emptyReason [
          ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]           ] )         ]       ] [
fhir:title [ fhir:v "16.3.2 胎児・胎盤移行性" ] ;
fhir:code [
          ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "13" ]           ] ) ;
fhir:text [ fhir:v "16.3.2 胎児・胎盤移行性" ]         ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"         ]       ] [
fhir:title [ fhir:v "16.3.3 蛋白結合率" ] ;
fhir:code [
          ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "13" ]           ] ) ;
fhir:text [ fhir:v "16.3.3 蛋白結合率" ]         ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"         ] ;
fhir:emptyReason [
          ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]           ] )         ]       ] )     ] [
fhir:title [ fhir:v "16.5 排泄" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "13" ]         ] ) ;
fhir:text [ fhir:v "16.5 排泄" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"       ] ;
fhir:emptyReason [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]         ] )       ] ;
      ( fhir:section [
fhir:title [ fhir:v "16.5.1" ] ;
fhir:code [
          ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "13" ]           ] ) ;
fhir:text [ fhir:v "16.5.1" ]         ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"         ] ;
fhir:emptyReason [
          ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]           ] )         ]       ] [
fhir:title [ fhir:v "16.5.2" ] ;
fhir:code [
          ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "13" ]           ] ) ;
fhir:text [ fhir:v "16.5.2" ]         ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"         ]       ] )     ] [
fhir:title [ fhir:v "16.6 特定の背景を有する患者" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "13" ]         ] ) ;
fhir:text [ fhir:v "16.6 特定の背景を有する患者" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"       ] ;
fhir:emptyReason [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]         ] )       ] ;
      ( fhir:section [
fhir:title [ fhir:v "16.6.1 腎機能障害患者における体内動態" ] ;
fhir:code [
          ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "13" ]           ] ) ;
fhir:text [ fhir:v "16.6.1 腎機能障害患者における体内動態" ]         ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"         ] ;
fhir:emptyReason [
          ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]           ] )         ]       ] [
fhir:title [ fhir:v "16.6.2 肝機能障害患者における体内動態" ] ;
fhir:code [
          ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "13" ]           ] ) ;
fhir:text [ fhir:v "16.6.2 肝機能障害患者における体内動態" ]         ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"         ]       ] )     ] )
  ] [
fhir:title [ fhir:v "17. 臨床成績" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "17" ]       ] ) ;
fhir:text [ fhir:v "17. 臨床成績" ]     ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"     ] ;
fhir:emptyReason [
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]       ] )     ] ;
    ( fhir:section [
fhir:title [ fhir:v "17.1 有効性及び安全性に関する試験" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "13" ]         ] ) ;
fhir:text [ fhir:v "17.1 有効性及び安全性に関する試験" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"       ] ;
fhir:emptyReason [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]         ] )       ] ;
      ( fhir:section [
fhir:title [ fhir:v "17.1.1 国内臨床試験" ] ;
fhir:code [
          ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "13" ]           ] ) ;
fhir:text [ fhir:v "17.1.1 国内臨床試験" ]         ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"         ] ;
fhir:emptyReason [
          ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]           ] )         ]       ] [
fhir:title [ fhir:v "17.1.2 ブリッジング試験" ] ;
fhir:code [
          ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "13" ]           ] ) ;
fhir:text [ fhir:v "17.1.2 ブリッジング試験" ]         ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"         ]       ] [
fhir:title [ fhir:v "17.1.3 海外臨床試験(第III相試験)" ] ;
fhir:code [
          ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "13" ]           ] ) ;
fhir:text [ fhir:v "17.1.3 海外臨床試験(第III相試験)" ]         ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"         ] ;
fhir:emptyReason [
          ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]           ] )         ]       ] [
fhir:title [ fhir:v "17.1.4 海外大規模比較試験(第III相試験 術後補助療法)" ] ;
fhir:code [
          ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "13" ]           ] ) ;
fhir:text [ fhir:v "17.1.4 海外大規模比較試験(第III相試験 術後補助療法)" ]         ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"         ]       ] [
fhir:title [ fhir:v "17.1.5 海外比較試験(術後補助療法)" ] ;
fhir:code [
          ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "13" ]           ] ) ;
fhir:text [ fhir:v "17.1.5 海外比較試験(術後補助療法)" ]         ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"         ] ;
fhir:emptyReason [
          ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]           ] )         ]       ] [
fhir:title [ fhir:v "17.1.6 非盲検無作為化比較試験(第II/III相試験 転移性乳癌に対する第一次 ホルモン療法)" ] ;
fhir:code [
          ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "16" ]           ] ) ;
fhir:text [ fhir:v "17.1.6 非盲検無作為化比較試験(第II/III相試験 転移性乳癌に対する第一次 ホルモン療法)" ]         ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"         ] ;
fhir:emptyReason [
          ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]           ] )         ]       ] )     ] )
  ] [
fhir:title [ fhir:v "18. 薬効薬理" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "18" ]       ] ) ;
fhir:text [ fhir:v "18. 薬効薬理" ]     ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"     ] ;
fhir:emptyReason [
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]       ] )     ] ;
    ( fhir:section [
fhir:title [ fhir:v "18.1 作用機序" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "17" ]         ] ) ;
fhir:text [ fhir:v "18.1 作用機序" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"       ] ;
fhir:emptyReason [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]         ] )       ] ;
      ( fhir:section [
fhir:title [ fhir:v "18.1.1 アロマターゼ阻害作用" ] ;
fhir:code [
          ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "17" ]           ] ) ;
fhir:text [ fhir:v "18.1.1 アロマターゼ阻害作用" ]         ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"         ] ;
fhir:emptyReason [
          ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]           ] )         ]       ] )     ] [
fhir:title [ fhir:v "18.2 抗腫瘍効果" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "17" ]         ] ) ;
fhir:text [ fhir:v "18.2 抗腫瘍効果" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"       ] ;
fhir:emptyReason [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]         ] )       ]     ] [
fhir:title [ fhir:v "18.3 エストロゲン抑制作用" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "17" ]         ] ) ;
fhir:text [ fhir:v "18.3 エストロゲン抑制作用" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"       ] ;
fhir:emptyReason [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]         ] )       ] ;
      ( fhir:section [
fhir:title [ fhir:v "18.3.1" ] ;
fhir:code [
          ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "17" ]           ] ) ;
fhir:text [ fhir:v "18.3.1" ]         ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"         ] ;
fhir:emptyReason [
          ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]           ] )         ]       ] [
fhir:title [ fhir:v "18.3.2" ] ;
fhir:code [
          ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "17" ]           ] ) ;
fhir:text [ fhir:v "18.3.2" ]         ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"         ] ;
fhir:emptyReason [
          ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]           ] )         ]       ] )     ] )
  ] [
fhir:title [ fhir:v "19. 有効成分に関する理化学的知見" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "19" ]       ] ) ;
fhir:text [ fhir:v "19. 有効成分に関する理化学的知見" ]     ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"     ] ;
fhir:emptyReason [
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]       ] )     ]
  ] [
fhir:title [ fhir:v "20. 取扱い上の注意" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "9" ]       ] ) ;
fhir:text [ fhir:v "20. 取扱い上の注意" ]     ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"     ] ;
fhir:emptyReason [
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]       ] )     ]
  ] [
fhir:title [ fhir:v "21. 承認条件" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "9" ]       ] ) ;
fhir:text [ fhir:v "21. 承認条件" ]     ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"     ] ;
fhir:emptyReason [
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]       ] )     ]
  ] [
fhir:title [ fhir:v "22. 包装" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "22" ]       ] ) ;
fhir:text [ fhir:v "22. 包装" ]     ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"     ] ;
fhir:emptyReason [
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]       ] )     ]
  ] [
fhir:title [ fhir:v "23. 主要文献" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "23" ]       ] ) ;
fhir:text [ fhir:v "23. 主要文献" ]     ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"     ] ;
fhir:emptyReason [
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]       ] )     ]
  ] [
fhir:title [ fhir:v "24. 文献請求先及び問い合わせ先" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "24" ]       ] ) ;
fhir:text [ fhir:v "24. 文献請求先及び問い合わせ先" ]     ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"     ]
  ] [
fhir:title [ fhir:v "25. 保険給付上の注意" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "9" ]       ] ) ;
fhir:text [ fhir:v "25. 保険給付上の注意" ]     ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"     ] ;
fhir:emptyReason [
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]       ] )     ]
  ] [
fhir:title [ fhir:v "26. 製造販売業者等" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "26" ]       ] ) ;
fhir:text [ fhir:v "26. 製造販売業者等" ]     ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"     ] ;
fhir:emptyReason [
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]       ] )     ]
  ] [
fhir:title [ fhir:v "26.1 製造販売元" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "https://pmda.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "26" ]       ] ) ;
fhir:text [ fhir:v "26.1 製造販売元" ]     ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"     ] ;
fhir:emptyReason [
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "unavailable" ]       ] )     ]
  ] ) . # 

<http://hl7.eu/fhir/ig/gravitate-health/Organization/orgohara> a fhir:Organization ;
  fhir:id [ fhir:v "orgohara"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_orgohara\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization orgohara</b></p><a name=\"orgohara\"> </a><a name=\"hcorgohara\"> </a><a name=\"orgohara-en-US\"> </a><p><b>identifier</b>: <code>https://pmda-org-id</code>/sim672212 (use: official, )</p><p><b>active</b>: true</p><p><b>type</b>: <span title=\"Codes:{https://PMDA-org-type.jp/ tbd}\">Marketing authorisation holder</span></p><p><b>name</b>: Ohara Pharmaceutical Co., Ltd.</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>15 Nihonbashi Muromachi, Chuo-ku, Tokyo 8324(work)</td></tr></table></div>"
  ] ; # 
  fhir:identifier ( [
fhir:use [ fhir:v "official" ] ;
fhir:system [ fhir:v "https://pmda-org-id"^^xsd:anyURI ] ;
fhir:value [ fhir:v "sim672212" ]
  ] ) ; # 
  fhir:active [ fhir:v "true"^^xsd:boolean] ; # 
  fhir:type ( [
    ( fhir:coding [
fhir:system [ fhir:v "https://PMDA-org-type.jp/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "tbd" ] ;
fhir:display [ fhir:v "Marketing authorisation holder" ]     ] ) ;
fhir:text [ fhir:v "Marketing authorisation holder" ]
  ] ) ; # 
  fhir:name [ fhir:v "Ohara Pharmaceutical Co., Ltd."] ; # 
  fhir:contact ( [
fhir:address [
fhir:use [ fhir:v "work" ] ;
fhir:type [ fhir:v "physical" ] ;
fhir:text [ fhir:v "15 Nihonbashi Muromachi, Chuo-ku, Tokyo 8324" ] ;
      ( fhir:line [ fhir:v "15 Nihonbashi Muromachi" ] ) ;
fhir:city [ fhir:v "Tokyo" ] ;
fhir:postalCode [ fhir:v "8324" ] ;
fhir:country [ fhir:v "Tokyo" ]     ]
  ] ) . # 

<http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/authsimvastatin20> a fhir:RegulatedAuthorization ;
  fhir:id [ fhir:v "authsimvastatin20"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/RegulatedAuthorization-uv-epi"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/RegulatedAuthorization-uv-epi>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"RegulatedAuthorization_authsimvastatin20\"> </a><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization authsimvastatin20</b></p><a name=\"authsimvastatin20\"> </a><a name=\"hcauthsimvastatin20\"> </a><a name=\"authsimvastatin20-en-US\"> </a><p><b>identifier</b>: <code>https://pmda-approvalandlicenseno/</code>/22500AMX01227000 (use: official, )</p><p><b>subject</b>: <a href=\"Bundle-bundlejpisimvastatin20.html#MedicinalProductDefinition_medprodsimvastatin20\">Bundle: identifier = https://www.pmda.jp/#jpiplaceholder; type = document; timestamp = 2002-08-01 13:28:17+0000</a></p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi/ /#100000072062}\">Marketing Authorisation</span></p><p><b>region</b>: <span title=\"Codes:{urn:iso:std:iso:3166 JP}\">Japan</span></p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">Active</span></p><p><b>statusDate</b>: 2002-08-01 13:28:17+0000</p><p><b>holder</b>: <a href=\"Organization-orgohara.html\">Organization Ohara Pharmaceutical Co., Ltd.</a></p></div>"
  ] ; # 
  fhir:identifier ( [
fhir:use [ fhir:v "official" ] ;
fhir:system [ fhir:v "https://pmda-approvalandlicenseno/"^^xsd:anyURI ] ;
fhir:value [ fhir:v "22500AMX01227000" ]
  ] ) ; # 
  fhir:subject ( [
fhir:reference [ fhir:v "MedicinalProductDefinition/medprodsimvastatin20" ]
  ] ) ; # 
  fhir:type [
    ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "/#100000072062" ]     ] ) ;
fhir:text [ fhir:v "Marketing Authorisation" ]
  ] ; # 
  fhir:region ( [
    ( fhir:coding [
fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ;
fhir:code [ fhir:v "JP" ]     ] ) ;
fhir:text [ fhir:v "Japan" ]
  ] ) ; # 
  fhir:status [
    ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/publication-status"^^xsd:anyURI ] ;
fhir:code [ fhir:v "active" ]     ] ) ;
fhir:text [ fhir:v "Active" ]
  ] ; # 
  fhir:statusDate [ fhir:v "2002-08-01T13:28:17Z"^^xsd:dateTime] ; # 
  fhir:holder [
fhir:reference [ fhir:v "Organization/orgohara" ]
  ] . # 

<http://hl7.eu/fhir/ig/gravitate-health/MedicinalProductDefinition/medprodsimvastatin20> a fhir:MedicinalProductDefinition ;
  fhir:id [ fhir:v "medprodsimvastatin20"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_medprodsimvastatin20\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition medprodsimvastatin20</b></p><a name=\"medprodsimvastatin20\"> </a><a name=\"hcmedprodsimvastatin20\"> </a><a name=\"medprodsimvastatin20-en-US\"> </a><p><b>identifier</b>: <code>http://iyaku.info/medicine</code>/2189011F1262</p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/medicinal-product-type MedicinalProduct}\">Medicinal Product</span></p><p><b>domain</b>: <span title=\"Codes:{http://hl7.org/fhir/medicinal-product-domain Human}\">Human use</span></p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">active</span></p><p><b>legalStatusOfSupply</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000072084}\">Medicinal product subject to medical prescription</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Simvastatin 20 mg tablets</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000001}\">Full name</span></p><blockquote><p><b>part</b></p><p><b>part</b>: Simvastatin</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000002}\">Invented name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: Simvastatin</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000003}\">Scientific name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 20 mg</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000004}\">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: tablet</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000005}\">Pharmaceutical dose form part</span></p></blockquote><h3>Usages</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Country</b></td><td><b>Jurisdiction</b></td><td><b>Language</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{urn:iso:std:iso:3166 JP}\">Japan</span></td><td><span title=\"Codes:{urn:iso:std:iso:3166 JP}\">Japan</span></td><td><span title=\"Codes:{urn:ietf:bcp:47 ja-JP}\">Japanese (Region=Japan)</span></td></tr></table></blockquote></div>"
  ] ; # 
  fhir:identifier ( [
fhir:system [ fhir:v "http://iyaku.info/medicine"^^xsd:anyURI ] ;
fhir:value [ fhir:v "2189011F1262" ]
  ] ) ; # 
  fhir:type [
    ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/medicinal-product-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "MedicinalProduct" ] ;
fhir:display [ fhir:v "Medicinal Product" ]     ] )
  ] ; # 
  fhir:domain [
    ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/medicinal-product-domain"^^xsd:anyURI ] ;
fhir:code [ fhir:v "Human" ] ;
fhir:display [ fhir:v "Human use" ]     ] )
  ] ; # 
  fhir:status [
    ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/publication-status"^^xsd:anyURI ] ;
fhir:code [ fhir:v "active" ] ;
fhir:display [ fhir:v "active" ]     ] )
  ] ; # 
  fhir:legalStatusOfSupply [
    ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ;
fhir:code [ fhir:v "100000072084" ] ;
fhir:display [ fhir:v "Medicinal product subject to medical prescription" ]     ] )
  ] ; # 
  fhir:name ( [
fhir:productName [ fhir:v "Simvastatin 20 mg tablets" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ;
fhir:code [ fhir:v "220000000001" ]       ] ) ;
fhir:text [ fhir:v "Full name" ]     ] ;
    ( fhir:part [
fhir:part [ fhir:v "Simvastatin" ] ;
fhir:type [
        ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ;
fhir:code [ fhir:v "220000000002" ]         ] ) ;
fhir:text [ fhir:v "Invented name part" ]       ]     ] [
fhir:part [ fhir:v "Simvastatin" ] ;
fhir:type [
        ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ;
fhir:code [ fhir:v "220000000003" ]         ] ) ;
fhir:text [ fhir:v "Scientific name part" ]       ]     ] [
fhir:part [ fhir:v "20 mg" ] ;
fhir:type [
        ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ;
fhir:code [ fhir:v "220000000004" ]         ] ) ;
fhir:text [ fhir:v "Strength part" ]       ]     ] [
fhir:part [ fhir:v "tablet" ] ;
fhir:type [
        ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ;
fhir:code [ fhir:v "220000000005" ]         ] ) ;
fhir:text [ fhir:v "Pharmaceutical dose form part" ]       ]     ] ) ;
    ( fhir:usage [
fhir:country [
        ( fhir:coding [
fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ;
fhir:code [ fhir:v "JP" ]         ] )       ] ;
fhir:jurisdiction [
        ( fhir:coding [
fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ;
fhir:code [ fhir:v "JP" ]         ] )       ] ;
fhir:language [
        ( fhir:coding [
fhir:system [ fhir:v "urn:ietf:bcp:47"^^xsd:anyURI ] ;
fhir:code [ fhir:v "ja-JP" ]         ] )       ]     ] )
  ] ) . # 

<http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/packsimvastatin20> a fhir:PackagedProductDefinition ;
  fhir:id [ fhir:v "packsimvastatin20"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PackagedProductDefinition_packsimvastatin20\"> </a><p class=\"res-header-id\"><b>Generated Narrative: PackagedProductDefinition packsimvastatin20</b></p><a name=\"packsimvastatin20\"> </a><a name=\"hcpacksimvastatin20\"> </a><a name=\"packsimvastatin20-en-US\"> </a><p><b>identifier</b>: <code>https://pmda-packinsertno/</code>/sim4291012F1022 (use: official, )</p><p><b>name</b>: Simvastatin 20 mg tablets blister</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000155527}\">Chemical Medininal Prodcut</span></p><p><b>packageFor</b>: <a href=\"Bundle-bundlejpisimvastatin20.html#MedicinalProductDefinition_medprodsimvastatin20\">Bundle: identifier = https://www.pmda.jp/#jpiplaceholder; type = document; timestamp = 2002-08-01 13:28:17+0000</a></p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">Active</span></p><p><b>statusDate</b>: 2002-08-01 13:28:17+0000</p><p><b>containedItemQuantity</b>: 20 mg</p><p><b>manufacturer</b>: <a href=\"Organization-orgohara.html\">Organization Ohara Pharmaceutical Co., Ltd.</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><code>https://spor.ema.europa.eu/pmswi</code>/placeholder</td><td><span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000073496}\">Blister</span></td><td>30</td><td><span title=\"Codes:{https://spor.ema.europa.eu/rmswi 200000003222}\">PolyVinyl Chloride</span></td></tr></table></div>"
  ] ; # 
  fhir:identifier ( [
fhir:use [ fhir:v "official" ] ;
fhir:system [ fhir:v "https://pmda-packinsertno/"^^xsd:anyURI ] ;
fhir:value [ fhir:v "sim4291012F1022" ]
  ] ) ; # 
  fhir:name [ fhir:v "Simvastatin 20 mg tablets blister"] ; # 
  fhir:type [
    ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ;
fhir:code [ fhir:v "100000155527" ] ;
fhir:display [ fhir:v "Chemical Medininal Prodcut" ]     ] )
  ] ; # 
  fhir:packageFor ( [
fhir:reference [ fhir:v "MedicinalProductDefinition/medprodsimvastatin20" ]
  ] ) ; # 
  fhir:status [
    ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/publication-status"^^xsd:anyURI ] ;
fhir:code [ fhir:v "active" ] ;
fhir:display [ fhir:v "Active" ]     ] )
  ] ; # 
  fhir:statusDate [ fhir:v "2002-08-01T13:28:17Z"^^xsd:dateTime] ; # 
  fhir:containedItemQuantity ( [
fhir:value [ fhir:v "20"^^xsd:decimal ] ;
fhir:unit [ fhir:v "mg" ]
  ] ) ; # 
  fhir:manufacturer ( [
fhir:reference [ fhir:v "Organization/orgohara" ]
  ] ) ; # 
  fhir:packaging [
    ( fhir:identifier [
fhir:system [ fhir:v "https://spor.ema.europa.eu/pmswi"^^xsd:anyURI ] ;
fhir:value [ fhir:v "placeholder" ]     ] ) ;
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ;
fhir:code [ fhir:v "100000073496" ] ;
fhir:display [ fhir:v "Blister" ]       ] )     ] ;
fhir:quantity [ fhir:v "30"^^xsd:integer ] ;
    ( fhir:material [
      ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ;
fhir:code [ fhir:v "200000003222" ] ;
fhir:display [ fhir:v "PolyVinyl Chloride" ]       ] )     ] )
  ] . # 

<http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/adminprodsimvastatin20> a fhir:AdministrableProductDefinition ;
  fhir:id [ fhir:v "adminprodsimvastatin20"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/AdministrableProductDefinition-uv-epi"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/AdministrableProductDefinition-uv-epi>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"AdministrableProductDefinition_adminprodsimvastatin20\"> </a><p class=\"res-header-id\"><b>Generated Narrative: AdministrableProductDefinition adminprodsimvastatin20</b></p><a name=\"adminprodsimvastatin20\"> </a><a name=\"hcadminprodsimvastatin20\"> </a><a name=\"adminprodsimvastatin20-en-US\"> </a><p><b>identifier</b>: <code>https://www.who-umc.org/phpid</code>/9721571303255BF02181E8EC5AD60DF9</p><p><b>status</b>: Active</p><p><b>formOf</b>: <a href=\"Bundle-bundlejpisimvastatin20.html#MedicinalProductDefinition_medprodsimvastatin20\">Bundle: identifier = https://www.pmda.jp/#jpiplaceholder; type = document; timestamp = 2002-08-01 13:28:17+0000</a></p><p><b>administrableDoseForm</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 10219000}\">Tablet</span></p><p><b>unitOfPresentation</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 15054000}\">15054000</span></p><p><b>producedFrom</b>: <a href=\"Bundle-bundlejpisimvastatin20.html#ManufacturedItemDefinition_manitemsimvastatin20\">Bundle: identifier = https://www.pmda.jp/#jpiplaceholder; type = document; timestamp = 2002-08-01 13:28:17+0000</a></p><h3>RouteOfAdministrations</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://spor.ema.europa.eu/rmswi 20053000}\">20053000</span></td></tr></table></div>"
  ] ; # 
  fhir:identifier ( [
fhir:system [ fhir:v "https://www.who-umc.org/phpid"^^xsd:anyURI ] ;
fhir:value [ fhir:v "9721571303255BF02181E8EC5AD60DF9" ]
  ] ) ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:formOf ( [
fhir:reference [ fhir:v "MedicinalProductDefinition/medprodsimvastatin20" ]
  ] ) ; # 
  fhir:administrableDoseForm [
    ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ;
fhir:code [ fhir:v "10219000" ]     ] ) ;
fhir:text [ fhir:v "Tablet" ]
  ] ; # 
  fhir:unitOfPresentation [
    ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ;
fhir:code [ fhir:v "15054000" ]     ] )
  ] ; # 
  fhir:producedFrom ( [
fhir:reference [ fhir:v "ManufacturedItemDefinition/manitemsimvastatin20" ]
  ] ) ; # 
  fhir:routeOfAdministration ( [
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ;
fhir:code [ fhir:v "20053000" ]       ] )     ]
  ] ) . # 

<http://hl7.eu/fhir/ig/gravitate-health/ManufacturedItemDefinition/manitemsimvastatin20> a fhir:ManufacturedItemDefinition ;
  fhir:id [ fhir:v "manitemsimvastatin20"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ManufacturedItemDefinition-uv-epi"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ManufacturedItemDefinition-uv-epi>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ManufacturedItemDefinition_manitemsimvastatin20\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ManufacturedItemDefinition manitemsimvastatin20</b></p><a name=\"manitemsimvastatin20\"> </a><a name=\"hcmanitemsimvastatin20\"> </a><a name=\"manitemsimvastatin20-en-US\"> </a><p><b>identifier</b>: <code>https://pmda-sccj</code>/sim874291 (use: official, )</p><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title=\"Codes:{https://standardterms.edqm.eu/browse/get_concepts_by/SOM/SOM/ 10219000}\">Tablet</span></p><p><b>unitOfPresentation</b>: <span title=\"Codes:{https://standardterms.edqm.eu/browse/get_concepts/UOP/ 15054000}\">15054000</span></p><p><b>manufacturer</b>: <a href=\"Organization-orgohara.html\">Organization Ohara Pharmaceutical Co., Ltd.</a></p></div>"
  ] ; # 
  fhir:identifier ( [
fhir:use [ fhir:v "official" ] ;
fhir:system [ fhir:v "https://pmda-sccj"^^xsd:anyURI ] ;
fhir:value [ fhir:v "sim874291" ]
  ] ) ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:manufacturedDoseForm [
    ( fhir:coding [
fhir:system [ fhir:v "https://standardterms.edqm.eu/browse/get_concepts_by/SOM/SOM/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "10219000" ]     ] ) ;
fhir:text [ fhir:v "Tablet" ]
  ] ; # 
  fhir:unitOfPresentation [
    ( fhir:coding [
fhir:system [ fhir:v "https://standardterms.edqm.eu/browse/get_concepts/UOP/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "15054000" ]     ] )
  ] ; # 
  fhir:manufacturer ( [
fhir:reference [ fhir:v "Organization/orgohara" ]
  ] ) . # 

<http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredientsimvastatin20> a fhir:Ingredient ;
  fhir:id [ fhir:v "ingredientsimvastatin20"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_ingredientsimvastatin20\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient ingredientsimvastatin20</b></p><a name=\"ingredientsimvastatin20\"> </a><a name=\"hcingredientsimvastatin20\"> </a><a name=\"ingredientsimvastatin20-en-US\"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/AGG2FN16EV (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: <a href=\"ManufacturedItemDefinition-manitemherceptin150.html\">ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000</a></p><p><b>role</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000072072}\">Active</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-orgohara.html\">Organization Ohara Pharmaceutical Co., Ltd.</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><span title=\"Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta AGG2FN16EV}\">trastazumab</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>20 mg</td><td><span title=\"Codes:{http://terminology.hl7.org/CodeSystem/v3-RoleClass ACTIB}\">active ingredient - basis of strength</span></td></tr></table></blockquote></div>"
  ] ; # 
  fhir:identifier [
fhir:use [ fhir:v "official" ] ;
fhir:system [ fhir:v "https://gsrs.ncats.nih.gov/ginas/app/beta/"^^xsd:anyURI ] ;
fhir:value [ fhir:v "AGG2FN16EV" ]
  ] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:for ( [
fhir:reference [ fhir:v "ManufacturedItemDefinition/manitemherceptin150" ]
  ] ) ; # 
  fhir:role [
    ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ;
fhir:code [ fhir:v "100000072072" ] ;
fhir:display [ fhir:v "Active" ]     ] )
  ] ; # 
  fhir:manufacturer ( [
fhir:manufacturer [
fhir:reference [ fhir:v "Organization/orgohara" ]     ]
  ] ) ; # 
  fhir:substance [
fhir:code [
fhir:concept [
        ( fhir:coding [
fhir:system [ fhir:v "https://gsrs.ncats.nih.gov/ginas/app/beta"^^xsd:anyURI ] ;
fhir:code [ fhir:v "AGG2FN16EV" ] ;
fhir:display [ fhir:v "trastazumab" ]         ] )       ]     ] ;
    ( fhir:strength [
fhir:presentation [
a fhir:Quantity ;
fhir:value [ fhir:v "20"^^xsd:decimal ] ;
fhir:unit [ fhir:v "mg" ]       ] ;
fhir:basis [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v3-RoleClass"^^xsd:anyURI ] ;
fhir:code [ fhir:v "ACTIB" ]         ] ) ;
fhir:text [ fhir:v "active ingredient - basis of strength" ]       ]     ] )
  ] . # 

<http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/subsimvastatin20> a fhir:SubstanceDefinition ;
  fhir:id [ fhir:v "subsimvastatin20"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_subsimvastatin20\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition subsimvastatin20</b></p><a name=\"subsimvastatin20\"> </a><a name=\"hcsubsimvastatin20\"> </a><a name=\"subsimvastatin20-en-US\"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/AGG2FN16EV (use: official, )</p><p><b>version</b>: 39</p><p><b>status</b>: <span title=\"Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta/ 1}\">Validated (UNII)</span></p><p><b>description</b>: </p><div><p>White to pale yellow</p>\n</div><p><b>manufacturer</b>: <a href=\"Organization-orgohara.html\">Organization Ohara Pharmaceutical Co., Ltd.</a></p><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>C25H38O5</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>simvastatin</td><td><span title=\"Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta/ 1}\">Chemical Name</span></td></tr></table></div>"
  ] ; # 
  fhir:identifier ( [
fhir:use [ fhir:v "official" ] ;
fhir:system [ fhir:v "https://gsrs.ncats.nih.gov/ginas/app/beta/"^^xsd:anyURI ] ;
fhir:value [ fhir:v "AGG2FN16EV" ]
  ] ) ; # 
  fhir:version [ fhir:v "39"] ; # 
  fhir:status [
    ( fhir:coding [
fhir:system [ fhir:v "https://gsrs.ncats.nih.gov/ginas/app/beta/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "1" ]     ] ) ;
fhir:text [ fhir:v "Validated (UNII)" ]
  ] ; # 
  fhir:description [ fhir:v "White to pale yellow"] ; # 
  fhir:manufacturer ( [
fhir:reference [ fhir:v "Organization/orgohara" ]
  ] ) ; # 
  fhir:structure [
fhir:molecularFormula [ fhir:v "C25H38O5" ]
  ] ; # 
  fhir:name ( [
fhir:name [ fhir:v "simvastatin" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "https://gsrs.ncats.nih.gov/ginas/app/beta/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "1" ]       ] ) ;
fhir:text [ fhir:v "Chemical Name" ]     ]
  ] ) . #