Gravitate Health FHIR Implementation Guide
0.1.0 - CI Build
Gravitate Health FHIR Implementation Guide
0.1.0 - CI Build
Gravitate Health FHIR Implementation Guide, published by Gravitate Health Project. 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/hl7-eu/gravitate-health/ and changes regularly. See the Directory of published versions
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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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"title" : "9.2.1 重度の腎障害のある患者",
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"title" : "9.3 肝機能障害患者",
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],
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"title" : "9.3.1 重度の肝障害のある患者",
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"title" : "9.5 妊婦",
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},
{
"title" : "10. 相互作用",
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],
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"title" : "10.2 併用注意(併用に注意すること)",
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"section" : [
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"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"
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"text" : {
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
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"section" : [
{
"title" : "11.1.1",
"code" : {
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{
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"code" : "11.1.1"
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"text" : "11.1.1"
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"text" : {
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
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},
{
"title" : "11.2 その他の副作用",
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{
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"code" : "11.2"
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"text" : "11.2 その他の副作用"
},
"text" : {
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
},
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]
},
{
"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\">unavailable</div>"
}
},
{
"title" : "13. 過量投与",
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{
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"code" : "13"
}
],
"text" : "13. 過量投与"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
},
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},
{
"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\">unavailable</div>"
},
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},
"section" : [
{
"title" : "14.1 薬剤交付時の注意",
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"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\">unavailable</div>"
},
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},
{
"title" : "15. その他の注意",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "13"
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],
"text" : "15. その他の注意"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
},
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},
"section" : [
{
"title" : "15.1",
"code" : {
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{
"system" : "https://pmda.jp/",
"code" : "13"
}
],
"text" : "15.1"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
},
"emptyReason" : {
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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>"
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]
},
{
"title" : "16. 薬物動態",
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"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\">unavailable</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\">unavailable</div>"
},
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}
},
{
"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\">unavailable</div>"
},
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]
},
"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\">unavailable</div>"
},
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]
},
{
"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\">unavailable</div>"
},
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"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>"
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},
{
"title" : "16.3.2 胎児・胎盤移行性",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "13"
}
],
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},
"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>"
},
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]
},
{
"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>"
},
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},
"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>"
},
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},
{
"title" : "16.5.2",
"code" : {
"coding" : [
{
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"code" : "13"
}
],
"text" : "16.5.2"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
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}
]
},
{
"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>"
},
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},
"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>"
},
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},
{
"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"
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],
"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"
}
],
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},
"text" : {
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},
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},
"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"
},
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"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
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},
"section" : [
{
"title" : "17.1.1 国内臨床試験",
"code" : {
"coding" : [
{
"system" : "https://pmda.jp/",
"code" : "13"
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],
"text" : "17.1.1 国内臨床試験"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
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},
{
"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"
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],
"text" : "17.1.3 海外臨床試験(第III相試験)"
},
"text" : {
"status" : "additional",
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},
{
"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"
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],
"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"
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],
"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>"
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},
{
"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" : [
{
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"code" : "16"
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],
"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",
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},
{
"title" : "18. 薬効薬理",
"code" : {
"coding" : [
{
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"code" : "18"
}
],
"text" : "18. 薬効薬理"
},
"text" : {
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},
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{
"title" : "18.1 作用機序",
"code" : {
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{
"system" : "https://pmda.jp/",
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],
"text" : "18.1 作用機序"
},
"text" : {
"status" : "additional",
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},
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"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>"
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},
{
"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>"
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},
{
"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>"
},
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"section" : [
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"title" : "18.3.1",
"code" : {
"coding" : [
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"code" : "17"
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],
"text" : "18.3.1"
},
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"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
},
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},
{
"title" : "18.3.2",
"code" : {
"coding" : [
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],
"text" : "18.3.2"
},
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
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},
{
"title" : "19. 有効成分に関する理化学的知見",
"code" : {
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"code" : "19"
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],
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},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
},
"emptyReason" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
"code" : "unavailable"
}
]
}
},
{
"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>"
},
"emptyReason" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
"code" : "unavailable"
}
]
}
},
{
"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>"
},
"emptyReason" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
"code" : "unavailable"
}
]
}
},
{
"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>"
},
"emptyReason" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
"code" : "unavailable"
}
]
}
},
{
"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>"
},
"emptyReason" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
"code" : "unavailable"
}
]
}
},
{
"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>"
},
"emptyReason" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
"code" : "unavailable"
}
]
}
},
{
"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>"
},
"emptyReason" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
"code" : "unavailable"
}
]
}
},
{
"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>"
},
"emptyReason" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
"code" : "unavailable"
}
]
}
}
]
}
},
{
"fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/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 class=\"res-header-id\"><b>Generated Narrative: Organization orgohara</b></p><a name=\"orgohara\"> </a><a name=\"hcorgohara\"> </a><a name=\"orgohara-en-US\"> </a><p><b>identifier</b>: <code>https://pmda-org-id</code>/sim672212\u00a0(use:\u00a0official,\u00a0)</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>: 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" : "http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/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 class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization authsimvastatin20</b></p><a name=\"authsimvastatin20\"> </a><a name=\"hcauthsimvastatin20\"> </a><a name=\"authsimvastatin20-en-US\"> </a><p><b>identifier</b>: <code>https://pmda-approvalandlicenseno/</code>/22500AMX01227000\u00a0(use:\u00a0official,\u00a0)</p><p><b>subject</b>: <a href=\"Bundle-bundlejpisimvastatin20.html#MedicinalProductDefinition_medprodsimvastatin20\">Bundle: identifier = https://www.pmda.jp/#jpiplaceholder; type = document; timestamp = 2002-08-01 13:28:17+0000</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=\"Organization-orgohara.html\">Organization Ohara Pharmaceutical Co., Ltd.</a></p></div>"
},
"identifier" : [
{
"use" : "official",
"system" : "https://pmda-approvalandlicenseno/",
"value" : "22500AMX01227000"
}
],
"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" : "http://hl7.eu/fhir/ig/gravitate-health/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 class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition medprodsimvastatin20</b></p><a name=\"medprodsimvastatin20\"> </a><a name=\"hcmedprodsimvastatin20\"> </a><a name=\"medprodsimvastatin20-en-US\"> </a><p><b>identifier</b>: <code>http://iyaku.info/medicine</code>/2189011F1262</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>: Simvastatin 20 mg tablets</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>: Simvastatin</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>: Simvastatin</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>: 20 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" : "2189011F1262"
}
],
"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-JP"
}
]
}
}
]
}
]
}
},
{
"fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/packsimvastatin20",
"resource" : {
"resourceType" : "PackagedProductDefinition",
"id" : "packsimvastatin20",
"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_packsimvastatin20\"> </a><p class=\"res-header-id\"><b>Generated Narrative: PackagedProductDefinition packsimvastatin20</b></p><a name=\"packsimvastatin20\"> </a><a name=\"hcpacksimvastatin20\"> </a><a name=\"packsimvastatin20-en-US\"> </a><p><b>identifier</b>: <code>https://pmda-packinsertno/</code>/sim4291012F1022\u00a0(use:\u00a0official,\u00a0)</p><p><b>name</b>: Simvastatin 20 mg tablets blister</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-bundlejpisimvastatin20.html#MedicinalProductDefinition_medprodsimvastatin20\">Bundle: identifier = https://www.pmda.jp/#jpiplaceholder; type = document; timestamp = 2002-08-01 13:28:17+0000</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>: 20 mg</p><p><b>manufacturer</b>: <a href=\"Organization-orgohara.html\">Organization Ohara 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>/placeholder</td><td><span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000073496}\">Blister</span></td><td>30</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" : "sim4291012F1022"
}
],
"name" : "Simvastatin 20 mg tablets blister",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000155527",
"display" : "Chemical Medininal Prodcut"
}
]
},
"packageFor" : [
{
"reference" : "MedicinalProductDefinition/medprodsimvastatin20"
}
],
"status" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/publication-status",
"code" : "active",
"display" : "Active"
}
]
},
"statusDate" : "2002-08-01T13:28:17Z",
"containedItemQuantity" : [
{
"value" : 20,
"unit" : "mg"
}
],
"manufacturer" : [
{
🔗 "reference" : "Organization/orgohara"
}
],
"packaging" : {
"identifier" : [
{
"system" : "https://spor.ema.europa.eu/pmswi",
"value" : "placeholder"
}
],
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000073496",
"display" : "Blister"
}
]
},
"quantity" : 30,
"material" : [
{
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000003222",
"display" : "PolyVinyl Chloride"
}
]
}
]
}
}
},
{
"fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/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 class=\"res-header-id\"><b>Generated Narrative: AdministrableProductDefinition adminprodsimvastatin20</b></p><a name=\"adminprodsimvastatin20\"> </a><a name=\"hcadminprodsimvastatin20\"> </a><a name=\"adminprodsimvastatin20-en-US\"> </a><p><b>identifier</b>: <code>https://www.who-umc.org/phpid</code>/9721571303255BF02181E8EC5AD60DF9</p><p><b>status</b>: Active</p><p><b>formOf</b>: <a href=\"Bundle-bundlejpisimvastatin20.html#MedicinalProductDefinition_medprodsimvastatin20\">Bundle: identifier = https://www.pmda.jp/#jpiplaceholder; type = document; timestamp = 2002-08-01 13:28:17+0000</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-bundlejpisimvastatin20.html#ManufacturedItemDefinition_manitemsimvastatin20\">Bundle: identifier = https://www.pmda.jp/#jpiplaceholder; type = document; timestamp = 2002-08-01 13:28:17+0000</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" : "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" : "http://hl7.eu/fhir/ig/gravitate-health/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 class=\"res-header-id\"><b>Generated Narrative: ManufacturedItemDefinition manitemsimvastatin20</b></p><a name=\"manitemsimvastatin20\"> </a><a name=\"hcmanitemsimvastatin20\"> </a><a name=\"manitemsimvastatin20-en-US\"> </a><p><b>identifier</b>: <code>https://pmda-sccj</code>/sim874291\u00a0(use:\u00a0official,\u00a0)</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=\"Organization-orgohara.html\">Organization Ohara Pharmaceutical Co., Ltd.</a></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" : "http://hl7.eu/fhir/ig/gravitate-health/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 class=\"res-header-id\"><b>Generated Narrative: Ingredient ingredientsimvastatin20</b></p><a name=\"ingredientsimvastatin20\"> </a><a name=\"hcingredientsimvastatin20\"> </a><a name=\"ingredientsimvastatin20-en-US\"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/AGG2FN16EV\u00a0(use:\u00a0official,\u00a0)</p><p><b>status</b>: Active</p><p><b>for</b>: <a href=\"ManufacturedItemDefinition-manitemherceptin150.html\">ManufacturedItemDefinition: identifier = https://pmda-sccj#874291\u00a0(use:\u00a0official,\u00a0); 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=\"Organization-orgohara.html\">Organization Ohara 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 AGG2FN16EV}\">trastazumab</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><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" : "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" : "http://hl7.eu/fhir/ig/gravitate-health/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 class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition subsimvastatin20</b></p><a name=\"subsimvastatin20\"> </a><a name=\"hcsubsimvastatin20\"> </a><a name=\"subsimvastatin20-en-US\"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/AGG2FN16EV\u00a0(use:\u00a0official,\u00a0)</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=\"Organization-orgohara.html\">Organization Ohara 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>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><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" : "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 © 2021+ Gravitate Health Project. Package hl7.eu.fhir.gh#0.1.0 based on FHIR 5.0.0. Generated 2024-11-20
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.
