Miscellaneous ePI Test, published by . 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/cander2/epi-test/ and changes regularly. See the Directory of published versions
@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 "Composition/compositionsimvastatin20jpi"^^xsd:anyURI ] ; ( fhir:resource <Composition/compositionsimvastatin20jpi> ) ] [ fhir:fullUrl [ fhir:v "Organization/orgohara"^^xsd:anyURI ] ; ( fhir:resource <Organization/orgohara> ) ] [ fhir:fullUrl [ fhir:v "Authorizations/authsimvastatin20"^^xsd:anyURI ] ; ( fhir:resource <Authorizations/authsimvastatin20> ) ] [ fhir:fullUrl [ fhir:v "MedicinalProductDefinition/medprodsimvastatin20"^^xsd:anyURI ] ; ( fhir:resource <MedicinalProductDefinition/medprodsimvastatin20> ) ] [ fhir:fullUrl [ fhir:v "PackagedProductDefinition/packherceptinvial"^^xsd:anyURI ] ; ( fhir:resource <PackagedProductDefinition/packherceptinvial> ) ] [ fhir:fullUrl [ fhir:v "AdministrableProductDefinition/adminprodsimvastatin20"^^xsd:anyURI ] ; ( fhir:resource <AdministrableProductDefinition/adminprodsimvastatin20> ) ] [ fhir:fullUrl [ fhir:v "ManufacturedItemDefinition/manitemsimvastatin20"^^xsd:anyURI ] ; ( fhir:resource <ManufacturedItemDefinition/manitemsimvastatin20> ) ] [ fhir:fullUrl [ fhir:v "Ingredient/ingredientsimvastatin20"^^xsd:anyURI ] ; ( fhir:resource <Ingredient/ingredientsimvastatin20> ) ] [ fhir:fullUrl [ fhir:v "SubstanceDefinition/subsimvastatin20"^^xsd:anyURI ] ; ( fhir:resource <SubstanceDefinition/subsimvastatin20> ) ] ) . # <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><b>Generated Narrative: Composition</b><a name=\"compositionsimvastatin20jpi\"> </a><a name=\"hccompositionsimvastatin20jpi\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Composition "compositionsimvastatin20jpi" (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>: Package Leaflet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#100000155538)</span></p><p><b>date</b>: 2002-08-01 13:28:17+0000</p><p><b>author</b>: <a href=\"Organization-orgchugai.html\">Organization/orgchugai</a> "Chugai Pharmaceutical Co., Ltd."</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>Official <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-composition-attestation-mode.html\">Composition Attestation Mode</a>#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/medprodherceptin150" ] ] ) ; # fhir:date [ fhir:v "2002-08-01T13:28:17Z"^^xsd:dateTime] ; # fhir:author ( [ fhir:reference [ fhir:v "Organization/orgchugai" ] ] ) ; # 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\"></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\"></div>" ] ; ( 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\"></div>" ] ] [ 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\"></div>" ] ] [ 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\"></div>" ] ] ) ] [ 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\"></div>" ] ; ( 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\"></div>" ] ] [ 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\"></div>" ] ] [ 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\"></div>" ] ] ) ] [ 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\"></div>" ] ; ( 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\"></div>" ] ] [ 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\"></div>" ] ] ) ] [ 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\"></div>" ] ] [ 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\"></div>" ] ] [ 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\"></div>" ] ] [ 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\"></div>" ] ] [ 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\"><p></p></div>" ] ; ( 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\"></div>" ] ] [ 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\"></div>" ] ] [ 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\"></div>" ] ] [ 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\"></div>" ] ] ) ] [ 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\"><p></p></div>" ] ; ( 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\"></div>" ] ] [ 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\"></div>" ] ; ( 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\"></div>" ] ] ) ] [ 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\"></div>" ] ; ( 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\"></div>" ] ] ) ] [ 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\"></div>" ] ] [ 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\"></div>" ] ] [ 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\"></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\"><p></p></div>" ] ; ( 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\"></div>" ] ] [ 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\"></div>" ] ] ) ] [ 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\"></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\"></div>" ] ; ( 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\"></div>" ] ] ) ] [ 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\"></div>" ] ] ) ] [ 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\"></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\"></div>" ] ] [ 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\"></div>" ] ; ( 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\"></div>" ] ] ) ] [ 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\"></div>" ] ; ( 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\"></div>" ] ] [ 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\"></div>" ] ] ) ] [ 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\"></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\"></div>" ] ] [ 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\"></div>" ] ; ( 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\"></div>" ] ] ) ] [ 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\"></div>" ] ; ( 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\"></div>" ] ] [ 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" ] ] ; 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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\"></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\"></div>" ] ; ( 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\"></div>" ] ] [ 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\"></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\"></div>" ] ; ( 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\"></div>" ] ; ( 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" ] ] ) ; 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fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></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\"></div>" ] ] [ 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\"></div>" ] ] ) ] ) ] [ 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\"></div>" ] ; ( 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\"></div>" ] ; ( 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\"></div>" ] ] ) ] [ 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\"></div>" ] ] [ 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\"></div>" ] ; ( 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\"></div>" ] ] [ 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\"></div>" ] ] ) ] ) ] [ 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\"></div>" ] ] [ 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\"></div>" ] ] [ 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\"></div>" ] ] [ 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\"></div>" ] ] [ 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\"></div>" ] ] [ 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\"></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\"></div>" ] ] [ 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\"></div>" ] ] [ 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\"></div>" ] ] ) . # <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><b>Generated Narrative: Organization</b><a name=\"orgohara\"> </a><a name=\"hcorgohara\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Organization "orgohara" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Organization-uv-epi.html\">Organization (ePI)</a></p></div><p><b>identifier</b>: <code>https://pmda-org-id</code>/sim672212 (use: 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\"> (#tbd)</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" ] ] ] ) . # <Authorizations/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><b>Generated Narrative: RegulatedAuthorization</b><a name=\"authsimvastatin20\"> </a><a name=\"hcauthsimvastatin20\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource RegulatedAuthorization "authsimvastatin20" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-RegulatedAuthorization-uv-epi.html\">RegulatedAuthorization (ePI)</a></p></div><p><b>identifier</b>: <code>https://pmda-approvalandlicenseno/</code>/21300AMY00128 (use: official)</p><p><b>subject</b>: See on this page: MedicinalProductDefinition/medprodsimvastatin20</p><p><b>type</b>: Marketing Authorisation <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#/#100000072062)</span></p><p><b>region</b>: Japan <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-ISO3166Part1.html\">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#jp)</span></p><p><b>status</b>: Active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-publication-status.html\">PublicationStatus</a>#active)</span></p><p><b>statusDate</b>: 2002-08-01 13:28:17+0000</p><p><b>holder</b>: See on this page: Organization/orgohara</p></div>" ] ; # fhir:identifier ( [ fhir:use [ fhir:v "official" ] ; fhir:system [ fhir:v "https://pmda-approvalandlicenseno/"^^xsd:anyURI ] ; fhir:value [ fhir:v "21300AMY00128" ] ] ) ; # 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" ] ] . # <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><b>Generated Narrative: MedicinalProductDefinition</b><a name=\"medprodsimvastatin20\"> </a><a name=\"hcmedprodsimvastatin20\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource MedicinalProductDefinition "medprodsimvastatin20" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-MedicinalProductDefinition-uv-epi.html\">MedicinalProductDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>http://www.pmda.jp/</code>/sim874291</p><p><b>type</b>: Medicinal Product <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-medicinal-product-type.html\">Medicinal Product Type</a>#MedicinalProduct)</span></p><p><b>domain</b>: Human use <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-medicinal-product-domain.html\">Medicinal Product Domain</a>#Human)</span></p><p><b>status</b>: active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-publication-status.html\">PublicationStatus</a>#active)</span></p><p><b>legalStatusOfSupply</b>: Medicinal product subject to medical prescription <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#100000072084)</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Simvastatin 20 mg tablets</p><p><b>type</b>: Full name <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (220000000000#220000000001)</span></p><blockquote><p><b>part</b></p><p><b>part</b>: Simvastatin</p><p><b>type</b>: Invented name part <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (220000000000#220000000002)</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: Simvastatin</p><p><b>type</b>: Scientific name part <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (220000000000#220000000003)</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 20 mg</p><p><b>type</b>: Strength part <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (220000000000#220000000004)</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: tablet</p><p><b>type</b>: Pharmaceutical dose form part <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (220000000000#220000000005)</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>Japan <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-ISO3166Part1.html\">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#JP)</span></td><td>Japan <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-ISO3166Part1.html\">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#JP)</span></td><td>JA <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-v3-ietf3066.html\">Tags for the Identification of Languages</a>#JA)</span></td></tr></table></blockquote></div>" ] ; # fhir:identifier ( [ fhir:system [ fhir:v "http://www.pmda.jp/"^^xsd:anyURI ] ; fhir:value [ fhir:v "sim874291" ] ] ) ; # 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" ] ] ) ] ] ) ] ) . # <PackagedProductDefinition/packherceptinvial> a fhir:PackagedProductDefinition ; fhir:id [ fhir:v "packherceptinvial"] ; # 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_packherceptinvial\"> </a><p><b>Generated Narrative: PackagedProductDefinition</b><a name=\"packherceptinvial\"> </a><a name=\"hcpackherceptinvial\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource PackagedProductDefinition "packherceptinvial" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-PackagedProductDefinition-uv-epi.html\">PackagedProductDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>https://pmda-packinsertno/</code>/4291012F1022 (use: official)</p><p><b>name</b>: Herceptin (trastazumab) 150 mg for Intravenous Use</p><p><b>type</b>: Chemical Medininal Prodcut <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#100000155527)</span></p><p><b>packageFor</b>: <a href=\"MedicinalProductDefinition-medprodherceptin150.html\">MedicinalProductDefinition/medprodherceptin150</a></p><p><b>status</b>: Active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-publication-status.html\">PublicationStatus</a>#active)</span></p><p><b>statusDate</b>: 2002-08-01 13:28:17+0000</p><p><b>containedItemQuantity</b>: 150 mg</p><p><b>manufacturer</b>: <a href=\"Organization-orgchugai.html\">Organization/orgchugai</a> "Chugai Pharmaceutical Co., Ltd."</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>/123456</td><td>Vial <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#100000073563)</span></td><td>28</td><td>Glass type I <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#200000003204)</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 "4291012F1022" ] ] ) ; # fhir:name [ fhir:v "Herceptin (trastazumab) 150 mg for Intravenous Use"] ; # 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/medprodherceptin150" ] ] ) ; # 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 "150"^^xsd:decimal ] ; fhir:unit [ fhir:v "mg" ] ] ) ; # fhir:manufacturer ( [ fhir:reference [ fhir:v "Organization/orgchugai" ] ] ) ; # fhir:packaging [ ( fhir:identifier [ fhir:system [ fhir:v "https://spor.ema.europa.eu/pmswi"^^xsd:anyURI ] ; fhir:value [ fhir:v "123456" ] ] ) ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000073563" ] ; fhir:display [ fhir:v "Vial" ] ] ) ] ; fhir:quantity [ fhir:v "28"^^xsd:integer ] ; ( fhir:material [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000003204" ] ; fhir:display [ fhir:v "Glass type I" ] ] ) ] ) ] . # <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><b>Generated Narrative: AdministrableProductDefinition</b><a name=\"adminprodsimvastatin20\"> </a><a name=\"hcadminprodsimvastatin20\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource AdministrableProductDefinition "adminprodsimvastatin20" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-AdministrableProductDefinition-uv-epi.html\">AdministrableProductDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>https://www.who-umc.org/phpid</code>/9721571303255BF02181E8EC5AD60DF9</p><p><b>status</b>: active</p><p><b>formOf</b>: See on this page: MedicinalProductDefinition/medprodsimvastatin20</p><p><b>administrableDoseForm</b>: Tablet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#10219000)</span></p><p><b>unitOfPresentation</b>: 15054000 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#15054000)</span></p><p><b>producedFrom</b>: See on this page: ManufacturedItemDefinition/manitemsimvastatin20</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>20053000 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#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" ] ] ) ] ] ) . # <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><b>Generated Narrative: ManufacturedItemDefinition</b><a name=\"manitemsimvastatin20\"> </a><a name=\"hcmanitemsimvastatin20\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ManufacturedItemDefinition "manitemsimvastatin20" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-ManufacturedItemDefinition-uv-epi.html\">ManufacturedItemDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>https://pmda-sccj</code>/sim874291 (use: official)</p><p><b>status</b>: active</p><p><b>manufacturedDoseForm</b>: Tablet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#10219000)</span></p><p><b>unitOfPresentation</b>: 15054000 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#15054000)</span></p><p><b>manufacturer</b>: See on this page: Organization/orgohara</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" ] ] ) . # <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><b>Generated Narrative: Ingredient</b><a name=\"ingredientsimvastatin20\"> </a><a name=\"hcingredientsimvastatin20\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Ingredient "ingredientsimvastatin20" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Ingredient-uv-epi.html\">Ingredient (ePI)</a></p></div><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/manitemherceptin150</a></p><p><b>role</b>: Active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#100000072072)</span></p><h3>Manufacturers</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Manufacturer</b></td></tr><tr><td style=\"display: none\">*</td><td>See on this page: Organization/orgohara</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>trastazumab <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (beta#AGG2FN16EV)</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>active ingredient - basis of strength <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-v3-RoleClass.html\">RoleClass</a>#ACTIB)</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" ] ] ] ) ] . # <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><b>Generated Narrative: SubstanceDefinition</b><a name=\"subsimvastatin20\"> </a><a name=\"hcsubsimvastatin20\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource SubstanceDefinition "subsimvastatin20" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-SubstanceDefinition-uv-epi.html\">SubstanceDefinition (ePI)</a></p></div><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>: Validated (UNII) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#1)</span></p><p><b>description</b>: White to pale yellow</p><p><b>manufacturer</b>: See on this page: Organization/orgohara</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>Chemical Name <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#1)</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" ] ] ] ) . #
IG © 2022+ . Package hl7.fhir.uv.epi-test#0.1.0 based on FHIR 5.0.0. Generated 2024-04-04
This joint undertaking receives support from the EU H2020 research and innovation programme and EFPIA.