Miscellaneous ePI Test
0.1.0 - CI Build
Miscellaneous ePI Test
0.1.0 - CI Build
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
{
"resourceType" : "Composition",
"id" : "trastazumabjpi",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi"
]
},
"language" : "ja",
"text" : {
"status" : "generated",
"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>"
},
"identifier" : [
{
"system" : "https://spor.ema.europa.eu/rmswi/",
"value" : "fcats34placeholder"
}
],
"status" : "final",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/",
"code" : "100000155538"
}
],
"text" : "Package Leaflet"
},
"subject" : [
{
🔗 "reference" : "MedicinalProductDefinition/medprodherceptin150"
}
],
"date" : "2002-08-01T13:28:17Z",
"author" : [
{
🔗 "reference" : "Organization/orgchugai"
}
],
"title" : "Herceptin (trastazumab) Package Leaflet - 150 mg for Intravenous Use",
"attester" : [
{
"mode" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/composition-attestation-mode",
"code" : "official"
}
]
},
"time" : "2002-08-01T13:28:17Z"
}
],
"section" : [
{
"title" : "アロマターゼ阻害剤/閉経後乳癌治療剤",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "0"
}
],
"text" : "アロマターゼ阻害剤/閉経後乳癌治療剤"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "1. 警告",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "1"
}
],
"text" : "1. 警告"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
{
"title" : "1.1",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "2.1"
}
],
"text" : "1.1"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "1.2",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "2.1"
}
],
"text" : "1.2"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "1.3",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "2.1"
}
],
"text" : "1.3"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
},
{
"title" : "2. 禁忌(次の患者には投与しないこと)",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "2"
}
],
"text" : "禁忌(次の患者には投与しないこと)"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
{
"title" : "2.1",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "2.1"
}
],
"text" : "2.1"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "2.2",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "2.2"
}
],
"text" : "2.2"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "2.3",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "2.3"
}
],
"text" : "2.3"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
},
{
"title" : "3. 組成・性状",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "3"
}
],
"text" : "3. 組成・性状"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
{
"title" : "3.1 組成",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "3.1"
}
],
"text" : "3.1 組成"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "3.2 製剤の性状",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "3.2"
}
],
"text" : "3.2 製剤の性状"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
},
{
"title" : "4. 効能又は効果",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "4"
}
],
"text" : "効能又は効果"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "5. 効能又は効果に関連する注意",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "5"
}
],
"text" : "効能又は効果に関連する注意"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "6. 用法及び用量",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "6"
}
],
"text" : "用法及び用量"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "7. 用法及び用量に関連する注意",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "7"
}
],
"text" : "7. 用法及び用量に関連する注意"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "8. 重要な基本的注意",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "8"
}
],
"text" : "重要な基本的注意"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p></p></div>"
},
"section" : [
{
"title" : "8.1",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "8.1"
}
],
"text" : "8.1"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "8.2",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "8.2"
}
],
"text" : "8.2"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "8.3",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "8.3"
}
],
"text" : "8.3"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "8.4",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "8.4"
}
],
"text" : "8.4"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
},
{
"title" : "9. 特定の背景を有する患者に関する注意",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "9"
}
],
"text" : "特定の背景を有する患者に関する注意"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p></p></div>"
},
"section" : [
{
"title" : "9.1",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "9.2"
}
],
"text" : "9.1"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "9.2 腎機能障害患者",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "9.2"
}
],
"text" : "9.2 腎機能障害患者"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
{
"title" : "9.2.1 重度の腎障害のある患者",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "9"
}
],
"text" : "9.2.1 重度の腎障害のある患者"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
},
{
"title" : "9.3 肝機能障害患者",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "9.3"
}
],
"text" : "9.3 肝機能障害患者"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
{
"title" : "9.3.1 重度の肝障害のある患者",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "9.3.1"
}
],
"text" : "9.3.1 重度の肝障害のある患者"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
},
{
"title" : "9.4",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "9.4"
}
],
"text" : "9.4"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "9.5 妊婦",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "9"
}
],
"text" : "9.5 妊婦"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "9.6 授乳婦",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "9.6"
}
],
"text" : "9.6 授乳婦"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
},
{
"title" : "10. 相互作用",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "10"
}
],
"text" : "10. 相互作用"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p></p></div>"
},
"section" : [
{
"title" : "10.1",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "9"
}
],
"text" : "10.1"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "10.2 併用注意(併用に注意すること)",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "10"
}
],
"text" : "10.2 併用注意(併用に注意すること)"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
},
{
"title" : "11. 副作用",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "11"
}
],
"text" : "11. 副作用"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
{
"title" : "11.1 重大な副作用",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "11.1"
}
],
"text" : "11.1 重大な副作用"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
{
"title" : "11.1.1",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "11.1.1"
}
],
"text" : "11.1.1"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
},
{
"title" : "11.2 その他の副作用",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "11.2"
}
],
"text" : "11.2 その他の副作用"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
},
{
"title" : "12. 臨床検査結果に及ぼす影響",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "12"
}
],
"text" : "12. 臨床検査結果に及ぼす影響"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "13. 過量投与",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "13"
}
],
"text" : "13. 過量投与"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "14. 適用上の注意",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "14"
}
],
"text" : "14. 適用上の注意"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
{
"title" : "14.1 薬剤交付時の注意",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "14.1"
}
],
"text" : "14.1 薬剤交付時の注意"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
},
{
"title" : "15. その他の注意",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "13"
}
],
"text" : "15. その他の注意"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
{
"title" : "15.1",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "13"
}
],
"text" : "15.1"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "15.2 非臨床試験に基づく情報",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "13"
}
],
"text" : "15.2 非臨床試験に基づく情報"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
},
{
"title" : "16. 薬物動態",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "13"
}
],
"text" : "16. 薬物動態"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
{
"title" : "16.1 血中濃度",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "13"
}
],
"text" : "16.1 血中濃度"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "16.2 吸収",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "13"
}
],
"text" : "16.2 吸収"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
{
"title" : "16.2.1 食事の影響",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "13"
}
],
"text" : "16.2.1 食事の影響"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
},
{
"title" : "16.3 分布",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "13"
}
],
"text" : "16.3 分布"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
{
"title" : "16.3.1 組織内濃度",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "13"
}
],
"text" : "16.3.1 組織内濃度"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "16.3.2 胎児・胎盤移行性",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "13"
}
],
"text" : "16.3.2 胎児・胎盤移行性"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "16.3.3 蛋白結合率",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "13"
}
],
"text" : "16.3.3 蛋白結合率"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
},
{
"title" : "16.5 排泄",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "13"
}
],
"text" : "16.5 排泄"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
{
"title" : "16.5.1",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "13"
}
],
"text" : "16.5.1"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "16.5.2",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "13"
}
],
"text" : "16.5.2"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
},
{
"title" : "16.6 特定の背景を有する患者",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "13"
}
],
"text" : "16.6 特定の背景を有する患者"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
{
"title" : "16.6.1 腎機能障害患者における体内動態",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "13"
}
],
"text" : "16.6.1 腎機能障害患者における体内動態"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "16.6.2 肝機能障害患者における体内動態",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "13"
}
],
"text" : "16.6.2 肝機能障害患者における体内動態"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
}
]
},
{
"title" : "17. 臨床成績",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "17"
}
],
"text" : "17. 臨床成績"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
{
"title" : "17.1 有効性及び安全性に関する試験",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "13"
}
],
"text" : "17.1 有効性及び安全性に関する試験"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
{
"title" : "17.1.1 国内臨床試験",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "13"
}
],
"text" : "17.1.1 国内臨床試験"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "17.1.2 ブリッジング試験",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "13"
}
],
"text" : "17.1.2 ブリッジング試験"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "17.1.3 海外臨床試験(第III相試験)",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "13"
}
],
"text" : "17.1.3 海外臨床試験(第III相試験)"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "17.1.4 海外大規模比較試験(第III相試験 術後補助療法)",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "13"
}
],
"text" : "17.1.4 海外大規模比較試験(第III相試験 術後補助療法)"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "17.1.5 海外比較試験(術後補助療法)",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "13"
}
],
"text" : "17.1.5 海外比較試験(術後補助療法)"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "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)",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "16"
}
],
"text" : "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)"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
}
]
},
{
"title" : "18. 薬効薬理",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "18"
}
],
"text" : "18. 薬効薬理"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
{
"title" : "18.1 作用機序",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "17"
}
],
"text" : "18.1 作用機序"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
{
"title" : "18.1.1 アロマターゼ阻害作用",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "17"
}
],
"text" : "18.1.1 アロマターゼ阻害作用"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
},
{
"title" : "18.2 抗腫瘍効果",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "17"
}
],
"text" : "18.2 抗腫瘍効果"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "18.3 エストロゲン抑制作用",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "17"
}
],
"text" : "18.3 エストロゲン抑制作用"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
{
"title" : "18.3.1",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "17"
}
],
"text" : "18.3.1"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "18.3.2",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "17"
}
],
"text" : "18.3.2"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
}
]
},
{
"title" : "19. 有効成分に関する理化学的知見",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "19"
}
],
"text" : "19. 有効成分に関する理化学的知見"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "20. 取扱い上の注意",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "9"
}
],
"text" : "20. 取扱い上の注意"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "21. 承認条件",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "9"
}
],
"text" : "21. 承認条件"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "22. 包装",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "22"
}
],
"text" : "22. 包装"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "23. 主要文献",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "23"
}
],
"text" : "23. 主要文献"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "24. 文献請求先及び問い合わせ先",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "24"
}
],
"text" : "24. 文献請求先及び問い合わせ先"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "25. 保険給付上の注意",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "9"
}
],
"text" : "25. 保険給付上の注意"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "26. 製造販売業者等",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "26"
}
],
"text" : "26. 製造販売業者等"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "26.1 製造販売元",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "26"
}
],
"text" : "26.1 製造販売元"
},
"text" : {
"status" : "additional",
"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
Links: Table of Contents |
QA Report
The Gravitate Health project has received funding from the IMI 2 Joint Undertaking under grant agreement No 945334.
This joint undertaking receives support from the EU H2020 research and innovation programme and EFPIA.
