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:Composition ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "trastazumabjpi"] ; # 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\"><p><b>Generated Narrative: Composition</b><a name=\"trastazumabjpi\"> </a><a name=\"hctrastazumabjpi\"> </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 "trastazumabjpi" (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>: Herceptin (trastazumab) 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 "Herceptin (trastazumab) 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" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></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\"></div>" ] ] ) ] [ 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\"></div>" ] ; ( 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\"></div>" ] ] [ 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\"></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" ] ] ) ; 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\"></div>" ] ] [ 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\"></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\"></div>" ] ] [ 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\"></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>" ] ] ) . #
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.