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" : "Bundle",
"id" : "bundlejpisimvastatin20",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi"
]
},
"language" : "ja",
"identifier" : {
"system" : "https://www.pmda.jp/",
"value" : "jpiplaceholder"
},
"type" : "document",
"timestamp" : "2002-08-01T13:28:17Z",
"entry" : [
{
"fullUrl" : "Composition/compositionsimvastatin20jpi",
"resource" : {
"resourceType" : "Composition",
"id" : "compositionsimvastatin20jpi",
"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\"><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>"
},
"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" : "simvastatin20 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>"
}
}
]
}
},
{
"fullUrl" : "Organization/orgohara",
"resource" : {
"resourceType" : "Organization",
"id" : "orgohara",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi"
]
},
"text" : {
"status" : "generated",
"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\u00a0(use:\u00a0official)</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>"
},
"identifier" : [
{
"use" : "official",
"system" : "https://pmda-org-id",
"value" : "sim672212"
}
],
"active" : true,
"type" : [
{
"coding" : [
{
"system" : "https://PMDA-org-type.jp/",
"code" : "tbd",
"display" : "Marketing authorisation holder"
}
],
"text" : "Marketing authorisation holder"
}
],
"name" : "Ohara Pharmaceutical Co., Ltd.",
"contact" : [
{
"address" : {
"use" : "work",
"type" : "physical",
"text" : "15 Nihonbashi Muromachi, Chuo-ku, Tokyo 8324",
"line" : [
"15 Nihonbashi Muromachi"
],
"city" : "Tokyo",
"postalCode" : "8324",
"country" : "Tokyo"
}
}
]
}
},
{
"fullUrl" : "Authorizations/authsimvastatin20",
"resource" : {
"resourceType" : "RegulatedAuthorization",
"id" : "authsimvastatin20",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/RegulatedAuthorization-uv-epi"
]
},
"text" : {
"status" : "generated",
"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\u00a0(use:\u00a0official)</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>"
},
"identifier" : [
{
"use" : "official",
"system" : "https://pmda-approvalandlicenseno/",
"value" : "21300AMY00128"
}
],
"subject" : [
{
🔗 "reference" : "MedicinalProductDefinition/medprodsimvastatin20"
}
],
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi/",
"code" : "/#100000072062"
}
],
"text" : "Marketing Authorisation"
},
"region" : [
{
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "jp"
}
],
"text" : "Japan"
}
],
"status" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/publication-status",
"code" : "active"
}
],
"text" : "Active"
},
"statusDate" : "2002-08-01T13:28:17Z",
"holder" : {
🔗 "reference" : "Organization/orgohara"
}
}
},
{
"fullUrl" : "MedicinalProductDefinition/medprodsimvastatin20",
"resource" : {
"resourceType" : "MedicinalProductDefinition",
"id" : "medprodsimvastatin20",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi"
]
},
"text" : {
"status" : "generated",
"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>"
},
"identifier" : [
{
"system" : "http://www.pmda.jp/",
"value" : "sim874291"
}
],
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/medicinal-product-type",
"code" : "MedicinalProduct",
"display" : "Medicinal Product"
}
]
},
"domain" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/medicinal-product-domain",
"code" : "Human",
"display" : "Human use"
}
]
},
"status" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/publication-status",
"code" : "active",
"display" : "active"
}
]
},
"legalStatusOfSupply" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000072084",
"display" : "Medicinal product subject to medical prescription"
}
]
},
"name" : [
{
"productName" : "Simvastatin 20 mg tablets",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/lists/220000000000",
"code" : "220000000001"
}
],
"text" : "Full name"
},
"part" : [
{
"part" : "Simvastatin",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/lists/220000000000",
"code" : "220000000002"
}
],
"text" : "Invented name part"
}
},
{
"part" : "Simvastatin",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/lists/220000000000",
"code" : "220000000003"
}
],
"text" : "Scientific name part"
}
},
{
"part" : "20 mg",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/lists/220000000000",
"code" : "220000000004"
}
],
"text" : "Strength part"
}
},
{
"part" : "tablet",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/lists/220000000000",
"code" : "220000000005"
}
],
"text" : "Pharmaceutical dose form part"
}
}
],
"usage" : [
{
"country" : {
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "JP"
}
]
},
"jurisdiction" : {
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "JP"
}
]
},
"language" : {
"coding" : [
{
"system" : "urn:ietf:bcp:47",
"code" : "JA"
}
]
}
}
]
}
]
}
},
{
"fullUrl" : "PackagedProductDefinition/packherceptinvial",
"resource" : {
"resourceType" : "PackagedProductDefinition",
"id" : "packherceptinvial",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi"
]
},
"text" : {
"status" : "generated",
"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\u00a0(use:\u00a0official)</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>"
},
"identifier" : [
{
"use" : "official",
"system" : "https://pmda-packinsertno/",
"value" : "4291012F1022"
}
],
"name" : "Herceptin (trastazumab) 150 mg for Intravenous Use",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000155527",
"display" : "Chemical Medininal Prodcut"
}
]
},
"packageFor" : [
{
🔗 "reference" : "MedicinalProductDefinition/medprodherceptin150"
}
],
"status" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/publication-status",
"code" : "active",
"display" : "Active"
}
]
},
"statusDate" : "2002-08-01T13:28:17Z",
"containedItemQuantity" : [
{
"value" : 150,
"unit" : "mg"
}
],
"manufacturer" : [
{
🔗 "reference" : "Organization/orgchugai"
}
],
"packaging" : {
"identifier" : [
{
"system" : "https://spor.ema.europa.eu/pmswi",
"value" : "123456"
}
],
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000073563",
"display" : "Vial"
}
]
},
"quantity" : 28,
"material" : [
{
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000003204",
"display" : "Glass type I"
}
]
}
]
}
}
},
{
"fullUrl" : "AdministrableProductDefinition/adminprodsimvastatin20",
"resource" : {
"resourceType" : "AdministrableProductDefinition",
"id" : "adminprodsimvastatin20",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/AdministrableProductDefinition-uv-epi"
]
},
"text" : {
"status" : "generated",
"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>"
},
"identifier" : [
{
"system" : "https://www.who-umc.org/phpid",
"value" : "9721571303255BF02181E8EC5AD60DF9"
}
],
"status" : "active",
"formOf" : [
{
🔗 "reference" : "MedicinalProductDefinition/medprodsimvastatin20"
}
],
"administrableDoseForm" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "10219000"
}
],
"text" : "Tablet"
},
"unitOfPresentation" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "15054000"
}
]
},
"producedFrom" : [
{
🔗 "reference" : "ManufacturedItemDefinition/manitemsimvastatin20"
}
],
"routeOfAdministration" : [
{
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "20053000"
}
]
}
}
]
}
},
{
"fullUrl" : "ManufacturedItemDefinition/manitemsimvastatin20",
"resource" : {
"resourceType" : "ManufacturedItemDefinition",
"id" : "manitemsimvastatin20",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ManufacturedItemDefinition-uv-epi"
]
},
"text" : {
"status" : "generated",
"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\u00a0(use:\u00a0official)</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>"
},
"identifier" : [
{
"use" : "official",
"system" : "https://pmda-sccj",
"value" : "sim874291"
}
],
"status" : "active",
"manufacturedDoseForm" : {
"coding" : [
{
"system" : "https://standardterms.edqm.eu/browse/get_concepts_by/SOM/SOM/",
"code" : "10219000"
}
],
"text" : "Tablet"
},
"unitOfPresentation" : {
"coding" : [
{
"system" : "https://standardterms.edqm.eu/browse/get_concepts/UOP/",
"code" : "15054000"
}
]
},
"manufacturer" : [
{
🔗 "reference" : "Organization/orgohara"
}
]
}
},
{
"fullUrl" : "Ingredient/ingredientsimvastatin20",
"resource" : {
"resourceType" : "Ingredient",
"id" : "ingredientsimvastatin20",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"
]
},
"text" : {
"status" : "generated",
"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\u00a0(use:\u00a0official)</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>"
},
"identifier" : {
"use" : "official",
"system" : "https://gsrs.ncats.nih.gov/ginas/app/beta/",
"value" : "AGG2FN16EV"
},
"status" : "active",
"for" : [
{
🔗 "reference" : "ManufacturedItemDefinition/manitemherceptin150"
}
],
"role" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000072072",
"display" : "Active"
}
]
},
"manufacturer" : [
{
"manufacturer" : {
🔗 "reference" : "Organization/orgohara"
}
}
],
"substance" : {
"code" : {
"concept" : {
"coding" : [
{
"system" : "https://gsrs.ncats.nih.gov/ginas/app/beta",
"code" : "AGG2FN16EV",
"display" : "trastazumab"
}
]
}
},
"strength" : [
{
"presentationQuantity" : {
"value" : 20,
"unit" : "mg"
},
"basis" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v3-RoleClass",
"code" : "ACTIB"
}
],
"text" : "active ingredient - basis of strength"
}
}
]
}
}
},
{
"fullUrl" : "SubstanceDefinition/subsimvastatin20",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "subsimvastatin20",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi"
]
},
"text" : {
"status" : "generated",
"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\u00a0(use:\u00a0official)</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>"
},
"identifier" : [
{
"use" : "official",
"system" : "https://gsrs.ncats.nih.gov/ginas/app/beta/",
"value" : "AGG2FN16EV"
}
],
"version" : "39",
"status" : {
"coding" : [
{
"system" : "https://gsrs.ncats.nih.gov/ginas/app/beta/",
"code" : "1"
}
],
"text" : "Validated (UNII)"
},
"description" : "White to pale yellow",
"manufacturer" : [
{
🔗 "reference" : "Organization/orgohara"
}
],
"structure" : {
"molecularFormula" : "C25H38O5"
},
"name" : [
{
"name" : "simvastatin",
"type" : {
"coding" : [
{
"system" : "https://gsrs.ncats.nih.gov/ginas/app/beta/",
"code" : "1"
}
],
"text" : "Chemical Name"
}
}
]
}
}
]
}
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.
