FHIR IG analytics| Package | hl7.eu.fhir.gh |
| Resource Type | Bundle |
| Id | Bundle-bundlejpicarbamazepine200.json |
| FHIR Version | R5 |
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No resources found
No narrative content found in resource
FHIR
FHIRsmith{
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"timestamp": "2002-08-01T13:28:17Z",
"entry": [
{
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"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"ja\" lang=\"ja\"><a name=\"Composition_carbamazepine200jpi\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition carbamazepine200jpi</b></p><a name=\"carbamazepine200jpi\"> </a><a name=\"hccarbamazepine200jpi\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Language: ja</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"http://hl7.org/fhir/uv/emedicinal-product-info/STU1/StructureDefinition-Composition-uv-epi.html\">Composition (ePI)</a></p></div><p><b>identifier</b>: <code>https://spor.ema.europa.eu/rmswi/</code>/fcats34placeholder</p><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/ 100000155538}\">Package Leaflet</span></p><p><b>date</b>: 2002-08-01 13:28:17+0000</p><p><b>author</b>: <a href=\"Bundle-bundlejpicarbamazepine200.html#Organization_orgfujinaga\">Organization Fujinaga Pharmaceutical Co., Ltd.</a></p><p><b>title</b>: Tegretol (carbamazepine) 200 mg for tablet</p><h3>Attesters</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Mode</b></td><td><b>Time</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://hl7.org/fhir/composition-attestation-mode official}\">Official</span></td><td>2002-08-01 13:28:17+0000</td></tr></table></div>"
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"date": "2002-08-01T13:28:17Z",
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"title": "Tegretol (carbamazepine) 200 mg for tablet",
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{
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{
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{
"title": "2. 禁忌(次の患者には投与しないこと)",
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"coding": [
{
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"code": "2"
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],
"text": "禁忌(次の患者には投与しないこと)"
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"status": "additional",
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{
"title": "2.2",
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}
}
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{
"title": "3. 組成・性状",
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"code": "3"
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"text": "3. 組成・性状"
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"title": "3.1 組成",
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],
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}
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"title": "3.2 製剤の性状",
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"code": "3.2"
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"text": "3.2 製剤の性状"
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}
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}
},
{
"title": "5. 効能又は効果に関連する注意",
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"code": "5"
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],
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"text": {
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}
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{
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}
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{
"title": "7. 用法及び用量に関連する注意",
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"code": "7"
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],
"text": "7. 用法及び用量に関連する注意"
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{
"title": "8. 重要な基本的注意",
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"code": "8"
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"text": "重要な基本的注意"
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},
"section": [
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"code": "8.1"
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},
{
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}
}
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{
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"system": "https://pmda.jp/",
"code": "9"
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],
"text": "特定の背景を有する患者に関する注意"
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"text": {
"status": "additional",
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},
"section": [
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"code": "9.2"
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}
},
{
"title": "9.2 腎機能障害患者",
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"code": "9.2"
}
],
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},
"text": {
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"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
},
"section": [
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"title": "9.2.1 重度の腎障害のある患者",
"code": {
"coding": [
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"code": "9"
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],
"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\">unavailable</div>"
}
}
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"code": "9.3"
}
],
"text": "9.3 肝機能障害患者"
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"text": {
"status": "additional",
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},
"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\">unavailable</div>"
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}
]
},
{
"title": "9.4",
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}
],
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"text": {
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"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
}
},
{
"title": "9.5 妊婦",
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"code": "9"
}
],
"text": "9.5 妊婦"
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"text": {
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}
},
{
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"code": "9.6"
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],
"text": "9.6 授乳婦"
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}
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},
{
"title": "10. 相互作用",
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"code": "10"
}
],
"text": "10. 相互作用"
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},
"section": [
{
"title": "10.1",
"code": {
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"code": "9"
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],
"text": "10.1"
},
"text": {
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}
},
{
"title": "10.2 併用注意(併用に注意すること)",
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"code": "10"
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],
"text": "10.2 併用注意(併用に注意すること)"
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"text": {
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}
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},
{
"title": "11. 副作用",
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"code": "11"
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],
"text": "11. 副作用"
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},
"section": [
{
"title": "11.1 重大な副作用",
"code": {
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"code": "11.1"
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],
"text": "11.1 重大な副作用"
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},
"section": [
{
"title": "11.1.1",
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"code": "11.1.1"
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"title": "11.2 その他の副作用",
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"text": "11.2 その他の副作用"
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}
}
]
},
{
"title": "12. 臨床検査結果に及ぼす影響",
"code": {
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"code": "12"
}
],
"text": "12. 臨床検査結果に及ぼす影響"
},
"text": {
"status": "additional",
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}
},
{
"title": "13. 過量投与",
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"code": "13"
}
],
"text": "13. 過量投与"
},
"text": {
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}
},
{
"title": "14. 適用上の注意",
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"code": "14"
}
],
"text": "14. 適用上の注意"
},
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},
"section": [
{
"title": "14.1 薬剤交付時の注意",
"code": {
"coding": [
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"system": "https://pmda.jp/",
"code": "14.1"
}
],
"text": "14.1 薬剤交付時の注意"
},
"text": {
"status": "additional",
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}
}
]
},
{
"title": "15. その他の注意",
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{
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"code": "13"
}
],
"text": "15. その他の注意"
},
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},
"section": [
{
"title": "15.1",
"code": {
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"code": "13"
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],
"text": "15.1"
},
"text": {
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}
},
{
"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\">unavailable</div>"
}
}
]
},
{
"title": "16. 薬物動態",
"code": {
"coding": [
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"code": "13"
}
],
"text": "16. 薬物動態"
},
"text": {
"status": "additional",
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},
"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",
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}
},
{
"title": "16.2 吸収",
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"code": "13"
}
],
"text": "16.2 吸収"
},
"text": {
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},
"section": [
{
"title": "16.2.1 食事の影響",
"code": {
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"code": "13"
}
],
"text": "16.2.1 食事の影響"
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"text": {
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}
}
]
},
{
"title": "16.3 分布",
"code": {
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"code": "13"
}
],
"text": "16.3 分布"
},
"text": {
"status": "additional",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</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\">unavailable</div>"
}
},
{
"title": "16.3.2 胎児・胎盤移行性",
"code": {
"coding": [
{
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"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\">unavailable</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\">unavailable</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\">unavailable</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\">unavailable</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\">unavailable</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\">unavailable</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\">unavailable</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\">unavailable</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\">unavailable</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\">unavailable</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\">unavailable</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\">unavailable</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\">unavailable</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\">unavailable</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\">unavailable</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\">unavailable</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\">unavailable</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\">unavailable</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\">unavailable</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\">unavailable</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\">unavailable</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\">unavailable</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\">unavailable</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\">unavailable</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\">unavailable</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\">unavailable</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\">unavailable</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\">unavailable</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\">unavailable</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\">unavailable</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\">unavailable</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\">unavailable</div>"
}
}
]
}
},
{
"fullUrl": "http://hl7.eu/fhir/ig/gravitate-health/Organization/orgfujinaga",
"resource": {
"resourceType": "Organization",
"id": "orgfujinaga",
"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_orgfujinaga\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization orgfujinaga</b></p><a name=\"orgfujinaga\"> </a><a name=\"hcorgfujinaga\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"http://hl7.org/fhir/uv/emedicinal-product-info/STU1/StructureDefinition-Organization-uv-epi.html\">Organization (ePI)</a></p></div><p><b>identifier</b>: <code>https://pmda-org-id</code>/fujinaga (use: official, )</p><p><b>active</b>: true</p><p><b>type</b>: <span title=\"Codes:{https://PMDA-org-type.jp/ tbd}\">Marketing authorisation holder</span></p><p><b>name</b>: Fujinaga 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>Medicine Consultation Office Front Place Nihonbashi 2-14-1 Nihonbashi, Chuo-ku,(work)</td></tr></table></div>"
},
"identifier": [
{
"use": "official",
"system": "https://pmda-org-id",
"value": "fujinaga"
}
],
"active": true,
"type": [
{
"coding": [
{
"system": "https://PMDA-org-type.jp/",
"code": "tbd",
"display": "Marketing authorisation holder"
}
],
"text": "Marketing authorisation holder"
}
],
"name": "Fujinaga Pharmaceutical Co., Ltd.",
"contact": [
{
"address": {
"use": "work",
"type": "physical",
"text": "Medicine Consultation Office Front Place Nihonbashi 2-14-1 Nihonbashi, Chuo-ku,",
"line": [
"2-14-1 Nihonbashi"
],
"city": "Chuo-ku",
"postalCode": "103-8324",
"country": "Tokyo"
}
}
]
}
},
{
"fullUrl": "http://hl7.eu/fhir/ig/gravitate-health/Authorizations/authcarbamazepine200",
"resource": {
"resourceType": "RegulatedAuthorization",
"id": "authcarbamazepine200",
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"RegulatedAuthorization_authcarbamazepine200\"> </a><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization authcarbamazepine200</b></p><a name=\"authcarbamazepine200\"> </a><a name=\"hcauthcarbamazepine200\"> </a><p><b>identifier</b>: <code>https://pmda-approvalandlicenseno/</code>/22700AMX00173 (use: official, )</p><p><b>subject</b>: <a href=\"Bundle-bundlejpicarbamazepine200.html#MedicinalProductDefinition_medprodcarbamazepine200\">MedicinalProductDefinition: identifier = http://iyaku.info/medicine#1139002F1070; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription</a></p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi/ /#100000072062}\">Marketing Authorisation</span></p><p><b>region</b>: <span title=\"Codes:{urn:iso:std:iso:3166 JP}\">Japan</span></p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">Active</span></p><p><b>statusDate</b>: 2002-08-01 13:28:17+0000</p><p><b>holder</b>: <a href=\"Bundle-bundlejpicarbamazepine200.html#Organization_orgfujinaga\">Organization Fujinaga Pharmaceutical Co., Ltd.</a></p></div>"
},
"identifier": [
{
"use": "official",
"system": "https://pmda-approvalandlicenseno/",
"value": "22700AMX00173"
}
],
"subject": [
{
"reference": "MedicinalProductDefinition/medprodcarbamazepine200"
}
],
"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/orgfujinaga"
}
}
},
{
"fullUrl": "http://hl7.eu/fhir/ig/gravitate-health/MedicinalProductDefinition/medprodcarbamazepine200",
"resource": {
"resourceType": "MedicinalProductDefinition",
"id": "medprodcarbamazepine200",
"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_medprodcarbamazepine200\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition medprodcarbamazepine200</b></p><a name=\"medprodcarbamazepine200\"> </a><a name=\"hcmedprodcarbamazepine200\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"http://hl7.org/fhir/uv/emedicinal-product-info/STU1/StructureDefinition-MedicinalProductDefinition-uv-epi.html\">MedicinalProductDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>http://iyaku.info/medicine</code>/1139002F1070</p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/medicinal-product-type MedicinalProduct}\">Medicinal Product</span></p><p><b>domain</b>: <span title=\"Codes:{http://hl7.org/fhir/medicinal-product-domain Human}\">Human use</span></p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">active</span></p><p><b>legalStatusOfSupply</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000072084}\">Medicinal product subject to medical prescription</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Tegretol (carbamazepine) 200 mg for tablet</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000001}\">Full name</span></p><blockquote><p><b>part</b></p><p><b>part</b>: Tegretol</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000002}\">Invented name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: carbamazepine</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000003}\">Scientific name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 200 mg</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000004}\">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: tablet</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000005}\">Pharmaceutical dose form part</span></p></blockquote><h3>Usages</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Country</b></td><td><b>Jurisdiction</b></td><td><b>Language</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{urn:iso:std:iso:3166 JP}\">Japan</span></td><td><span title=\"Codes:{urn:iso:std:iso:3166 JP}\">Japan</span></td><td><span title=\"Codes:{urn:ietf:bcp:47 ja-JP}\">Japanese (Region=Japan)</span></td></tr></table></blockquote></div>"
},
"identifier": [
{
"system": "http://iyaku.info/medicine",
"value": "1139002F1070"
}
],
"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": "Tegretol (carbamazepine) 200 mg for tablet",
"type": {
"coding": [
{
"system": "https://spor.ema.europa.eu/lists/220000000000",
"code": "220000000001"
}
],
"text": "Full name"
},
"part": [
{
"part": "Tegretol",
"type": {
"coding": [
{
"system": "https://spor.ema.europa.eu/lists/220000000000",
"code": "220000000002"
}
],
"text": "Invented name part"
}
},
{
"part": "carbamazepine",
"type": {
"coding": [
{
"system": "https://spor.ema.europa.eu/lists/220000000000",
"code": "220000000003"
}
],
"text": "Scientific name part"
}
},
{
"part": "200 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-JP"
}
]
}
}
]
}
]
}
},
{
"fullUrl": "http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/packcarbamazepine200",
"resource": {
"resourceType": "PackagedProductDefinition",
"id": "packcarbamazepine200",
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PackagedProductDefinition_packcarbamazepine200\"> </a><p class=\"res-header-id\"><b>Generated Narrative: PackagedProductDefinition packcarbamazepine200</b></p><a name=\"packcarbamazepine200\"> </a><a name=\"hcpackcarbamazepine200\"> </a><p><b>identifier</b>: <code>https://pmda-packinsertno/</code>/placeholder2 (use: official, )</p><p><b>name</b>: Tegretol (carbamazepine) 200 mg for tablet in bottles</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000155527}\">Chemical Medininal Prodcut</span></p><p><b>packageFor</b>: <a href=\"Bundle-bundlejpicarbamazepine200.html#MedicinalProductDefinition_medprodcarbamazepine200\">MedicinalProductDefinition: identifier = http://iyaku.info/medicine#1139002F1070; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription</a></p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">Active</span></p><p><b>statusDate</b>: 2002-08-01 13:28:17+0000</p><p><b>containedItemQuantity</b>: 200 mg</p><p><b>manufacturer</b>: <a href=\"Bundle-bundlejpicarbamazepine200.html#Organization_orgfujinaga\">Organization Fujinaga Pharmaceutical Co., Ltd.</a></p><h3>Packagings</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Identifier</b></td><td><b>Type</b></td><td><b>Quantity</b></td><td><b>Material</b></td></tr><tr><td style=\"display: none\">*</td><td><code>https://spor.ema.europa.eu/pmswi</code>/123456</td><td><span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000073497}\">Bottle</span></td><td>28</td><td><span title=\"Codes:{https://spor.ema.europa.eu/rmswi 200000003222}\">PolyVinyl Chloride</span></td></tr></table></div>"
},
"identifier": [
{
"use": "official",
"system": "https://pmda-packinsertno/",
"value": "placeholder2"
}
],
"name": "Tegretol (carbamazepine) 200 mg for tablet in bottles",
"type": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "100000155527",
"display": "Chemical Medininal Prodcut"
}
]
},
"packageFor": [
{
"reference": "MedicinalProductDefinition/medprodcarbamazepine200"
}
],
"status": {
"coding": [
{
"system": "http://hl7.org/fhir/publication-status",
"code": "active",
"display": "Active"
}
]
},
"statusDate": "2002-08-01T13:28:17Z",
"containedItemQuantity": [
{
"value": 200,
"unit": "mg"
}
],
"manufacturer": [
{
"reference": "Organization/orgfujinaga"
}
],
"packaging": {
"identifier": [
{
"system": "https://spor.ema.europa.eu/pmswi",
"value": "123456"
}
],
"type": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "100000073497",
"display": "Bottle"
}
]
},
"quantity": 28,
"material": [
{
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "200000003222",
"display": "PolyVinyl Chloride"
}
]
}
]
}
}
},
{
"fullUrl": "http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/adminprodcarbamazepine200",
"resource": {
"resourceType": "AdministrableProductDefinition",
"id": "adminprodcarbamazepine200",
"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_adminprodcarbamazepine200\"> </a><p class=\"res-header-id\"><b>Generated Narrative: AdministrableProductDefinition adminprodcarbamazepine200</b></p><a name=\"adminprodcarbamazepine200\"> </a><a name=\"hcadminprodcarbamazepine200\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"http://hl7.org/fhir/uv/emedicinal-product-info/STU1/StructureDefinition-AdministrableProductDefinition-uv-epi.html\">AdministrableProductDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>https://www.who-umc.org/phpid</code>/FB9808F4FED210183F412F9998622287</p><p><b>status</b>: Active</p><p><b>formOf</b>: <a href=\"Bundle-bundlejpicarbamazepine200.html#MedicinalProductDefinition_medprodcarbamazepine200\">MedicinalProductDefinition: identifier = http://iyaku.info/medicine#1139002F1070; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription</a></p><p><b>administrableDoseForm</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 10219000}\">Tablet</span></p><p><b>unitOfPresentation</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 15054000}\">15054000</span></p><p><b>producedFrom</b>: <a href=\"Bundle-bundlejpicarbamazepine200.html#ManufacturedItemDefinition_manitemcarbamazepine200\">ManufacturedItemDefinition: identifier = https://pmda-sccj#placeholder (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000</a></p><h3>RouteOfAdministrations</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://spor.ema.europa.eu/rmswi 20053000}\">20053000</span></td></tr></table></div>"
},
"identifier": [
{
"system": "https://www.who-umc.org/phpid",
"value": "FB9808F4FED210183F412F9998622287"
}
],
"status": "active",
"formOf": [
{
"reference": "MedicinalProductDefinition/medprodcarbamazepine200"
}
],
"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/manitemcarbamazepine200"
}
],
"routeOfAdministration": [
{
"code": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "20053000"
}
]
}
}
]
}
},
{
"fullUrl": "http://hl7.eu/fhir/ig/gravitate-health/ManufacturedItemDefinition/manitemcarbamazepine200",
"resource": {
"resourceType": "ManufacturedItemDefinition",
"id": "manitemcarbamazepine200",
"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_manitemcarbamazepine200\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ManufacturedItemDefinition manitemcarbamazepine200</b></p><a name=\"manitemcarbamazepine200\"> </a><a name=\"hcmanitemcarbamazepine200\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"http://hl7.org/fhir/uv/emedicinal-product-info/STU1/StructureDefinition-ManufacturedItemDefinition-uv-epi.html\">ManufacturedItemDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>https://pmda-sccj</code>/placeholder (use: official, )</p><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title=\"Codes:{https://standardterms.edqm.eu/browse/get_concepts_by/SOM/SOM/ 10219000}\">Tablet</span></p><p><b>unitOfPresentation</b>: <span title=\"Codes:{https://standardterms.edqm.eu/browse/get_concepts/UOP/ 15054000}\">15054000</span></p><p><b>manufacturer</b>: <a href=\"Bundle-bundlejpicarbamazepine200.html#Organization_orgfujinaga\">Organization Fujinaga Pharmaceutical Co., Ltd.</a></p></div>"
},
"identifier": [
{
"use": "official",
"system": "https://pmda-sccj",
"value": "placeholder"
}
],
"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/orgfujinaga"
}
]
}
},
{
"fullUrl": "http://hl7.eu/fhir/ig/gravitate-health/Ingredient/carbamazepine",
"resource": {
"resourceType": "Ingredient",
"id": "carbamazepine",
"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_carbamazepine\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient carbamazepine</b></p><a name=\"carbamazepine\"> </a><a name=\"hccarbamazepine\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"http://hl7.org/fhir/uv/emedicinal-product-info/STU1/StructureDefinition-Ingredient-uv-epi.html\">Ingredient (ePI)</a></p></div><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/33CM23913M (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: <a href=\"Bundle-bundlejpicarbamazepine200.html#ManufacturedItemDefinition_manitemcarbamazepine200\">ManufacturedItemDefinition: identifier = https://pmda-sccj#placeholder (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000</a></p><p><b>role</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000072072}\">Active</span></p><h3>Manufacturers</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Manufacturer</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-bundlejpicarbamazepine200.html#Organization_orgfujinaga\">Organization Fujinaga Pharmaceutical Co., Ltd.</a></td></tr></table><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta 33CM23913M}\">carbamazepine</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>200 mg</td><td><span title=\"Codes:{http://terminology.hl7.org/CodeSystem/v3-RoleClass ACTIB}\">active ingredient - basis of strength</span></td></tr></table></blockquote></div>"
},
"identifier": {
"use": "official",
"system": "https://gsrs.ncats.nih.gov/ginas/app/beta/",
"value": "33CM23913M"
},
"status": "active",
"for": [
{
"reference": "ManufacturedItemDefinition/manitemcarbamazepine200"
}
],
"role": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "100000072072",
"display": "Active"
}
]
},
"manufacturer": [
{
"manufacturer": {
"reference": "Organization/orgfujinaga"
}
}
],
"substance": {
"code": {
"concept": {
"coding": [
{
"system": "https://gsrs.ncats.nih.gov/ginas/app/beta",
"code": "33CM23913M",
"display": "carbamazepine"
}
]
}
},
"strength": [
{
"presentationQuantity": {
"value": 200,
"unit": "mg"
},
"basis": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-RoleClass",
"code": "ACTIB"
}
],
"text": "active ingredient - basis of strength"
}
}
]
}
}
},
{
"fullUrl": "http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/subcarbamazepine200",
"resource": {
"resourceType": "SubstanceDefinition",
"id": "subcarbamazepine200",
"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_subcarbamazepine200\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition subcarbamazepine200</b></p><a name=\"subcarbamazepine200\"> </a><a name=\"hcsubcarbamazepine200\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"http://hl7.org/fhir/uv/emedicinal-product-info/STU1/StructureDefinition-SubstanceDefinition-uv-epi.html\">SubstanceDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/33CM23913M (use: official, )</p><p><b>version</b>: 39</p><p><b>status</b>: <span title=\"Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta/ 1}\">Validated (UNII)</span></p><p><b>description</b>: </p><div><p>White to pale yellow</p>\n</div><p><b>manufacturer</b>: <a href=\"Bundle-bundlejpicarbamazepine200.html#Organization_orgfujinaga\">Organization Fujinaga Pharmaceutical Co., Ltd.</a></p><h3>Structures</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>MolecularFormula</b></td></tr><tr><td style=\"display: none\">*</td><td>C15H12N2O</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>carbamazepine</td><td><span title=\"Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta/ 1}\">Chemical Name</span></td></tr></table></div>"
},
"identifier": [
{
"use": "official",
"system": "https://gsrs.ncats.nih.gov/ginas/app/beta/",
"value": "33CM23913M"
}
],
"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/orgfujinaga"
}
],
"structure": {
"molecularFormula": "C15H12N2O"
},
"name": [
{
"name": "carbamazepine",
"type": {
"coding": [
{
"system": "https://gsrs.ncats.nih.gov/ginas/app/beta/",
"code": "1"
}
],
"text": "Chemical Name"
}
}
]
}
}
]
}