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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<div xmlns="http://www.w3.org/1999/xhtml" xml:lang="ja" lang="ja"><a name="Composition_trastazumabjpi"> </a><p class="res-header-id"><b>Generated Narrative: Composition trastazumabjpi</b></p><a name="trastazumabjpi"> </a><a name="hctrastazumabjpi"> </a><a name="trastazumabjpi-en-US"> </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="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>: <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="Organization-orgchugai.html">Organization Chugai Pharmaceutical Co., Ltd.</a></p><p><b>title</b>: Herceptin (trastazumab) Package Leaflet - 150 mg for Intravenous Use</p><h3>Attesters</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Mode</b></td><td><b>Time</b></td></tr><tr><td style="display: none">*</td><td><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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<coding>
<system value="https://pmda.jp/"/>
<code value="12"/>
</coding>
<text value="12. 臨床検査結果に及ぼす影響"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
</section>
<section>
<title value="13. 過量投与"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="13"/>
</coding>
<text value="13. 過量投与"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
</section>
<section>
<title value="14. 適用上の注意"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="14"/>
</coding>
<text value="14. 適用上の注意"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
<section>
<title value="14.1 薬剤交付時の注意"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="14.1"/>
</coding>
<text value="14.1 薬剤交付時の注意"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
</section>
</section>
<section>
<title value="15. その他の注意"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="13"/>
</coding>
<text value="15. その他の注意"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
<section>
<title value="15.1"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="13"/>
</coding>
<text value="15.1"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
</section>
<section>
<title value="15.2 非臨床試験に基づく情報"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="13"/>
</coding>
<text value="15.2 非臨床試験に基づく情報"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
</section>
</section>
<section>
<title value="16. 薬物動態"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="13"/>
</coding>
<text value="16. 薬物動態"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
<section>
<title value="16.1 血中濃度"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="13"/>
</coding>
<text value="16.1 血中濃度"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
</section>
<section>
<title value="16.2 吸収"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="13"/>
</coding>
<text value="16.2 吸収"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
<section>
<title value="16.2.1 食事の影響"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="13"/>
</coding>
<text value="16.2.1 食事の影響"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
</section>
</section>
<section>
<title value="16.3 分布"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="13"/>
</coding>
<text value="16.3 分布"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
<section>
<title value="16.3.1 組織内濃度"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="13"/>
</coding>
<text value="16.3.1 組織内濃度"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
</section>
<section>
<title value="16.3.2 胎児・胎盤移行性"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="13"/>
</coding>
<text value="16.3.2 胎児・胎盤移行性"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
</section>
<section>
<title value="16.3.3 蛋白結合率"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="13"/>
</coding>
<text value="16.3.3 蛋白結合率"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
</section>
</section>
<section>
<title value="16.5 排泄"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="13"/>
</coding>
<text value="16.5 排泄"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
<section>
<title value="16.5.1"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="13"/>
</coding>
<text value="16.5.1"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
</section>
<section>
<title value="16.5.2"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="13"/>
</coding>
<text value="16.5.2"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
</section>
</section>
<section>
<title value="16.6 特定の背景を有する患者"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="13"/>
</coding>
<text value="16.6 特定の背景を有する患者"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
<section>
<title value="16.6.1 腎機能障害患者における体内動態"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="13"/>
</coding>
<text value="16.6.1 腎機能障害患者における体内動態"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
</section>
<section>
<title value="16.6.2 肝機能障害患者における体内動態"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="13"/>
</coding>
<text value="16.6.2 肝機能障害患者における体内動態"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
</section>
</section>
</section>
<section>
<title value="17. 臨床成績"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="17"/>
</coding>
<text value="17. 臨床成績"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
<section>
<title value="17.1 有効性及び安全性に関する試験"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="13"/>
</coding>
<text value="17.1 有効性及び安全性に関する試験"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
<section>
<title value="17.1.1 国内臨床試験"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="13"/>
</coding>
<text value="17.1.1 国内臨床試験"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
</section>
<section>
<title value="17.1.2 ブリッジング試験"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="13"/>
</coding>
<text value="17.1.2 ブリッジング試験"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
</section>
<section>
<title value="17.1.3 海外臨床試験(第III相試験)"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="13"/>
</coding>
<text value="17.1.3 海外臨床試験(第III相試験)"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
</section>
<section>
<title value="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 value="https://pmda.jp/"/>
<code value="13"/>
</coding>
<text value="17.1.4 海外大規模比較試験(第III相試験 術後補助療法)"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
</section>
<section>
<title value="17.1.5 海外比較試験(術後補助療法)"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="13"/>
</coding>
<text value="17.1.5 海外比較試験(術後補助療法)"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
</section>
<section>
<title
value="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 value="https://pmda.jp/"/>
<code value="16"/>
</coding>
<text
value="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>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
</section>
</section>
</section>
<section>
<title value="18. 薬効薬理"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="18"/>
</coding>
<text value="18. 薬効薬理"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
<section>
<title value="18.1 作用機序"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="17"/>
</coding>
<text value="18.1 作用機序"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
<section>
<title value="18.1.1 アロマターゼ阻害作用"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="17"/>
</coding>
<text value="18.1.1 アロマターゼ阻害作用"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
</section>
</section>
<section>
<title value="18.2 抗腫瘍効果"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="17"/>
</coding>
<text value="18.2 抗腫瘍効果"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
</section>
<section>
<title value="18.3 エストロゲン抑制作用"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="17"/>
</coding>
<text value="18.3 エストロゲン抑制作用"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
<section>
<title value="18.3.1"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="17"/>
</coding>
<text value="18.3.1"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
</section>
<section>
<title value="18.3.2"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="17"/>
</coding>
<text value="18.3.2"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
</section>
</section>
</section>
<section>
<title value="19. 有効成分に関する理化学的知見"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="19"/>
</coding>
<text value="19. 有効成分に関する理化学的知見"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
</section>
<section>
<title value="20. 取扱い上の注意"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="9"/>
</coding>
<text value="20. 取扱い上の注意"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
</section>
<section>
<title value="21. 承認条件"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="9"/>
</coding>
<text value="21. 承認条件"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
</section>
<section>
<title value="22. 包装"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="22"/>
</coding>
<text value="22. 包装"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
</section>
<section>
<title value="23. 主要文献"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="23"/>
</coding>
<text value="23. 主要文献"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
</section>
<section>
<title value="24. 文献請求先及び問い合わせ先"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="24"/>
</coding>
<text value="24. 文献請求先及び問い合わせ先"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
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<emptyReason>
<coding>
<system
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<code value="unavailable"/>
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<section>
<title value="25. 保険給付上の注意"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="9"/>
</coding>
<text value="25. 保険給付上の注意"/>
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<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
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<code value="unavailable"/>
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</emptyReason>
</section>
<section>
<title value="26. 製造販売業者等"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="26"/>
</coding>
<text value="26. 製造販売業者等"/>
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<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
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<code value="unavailable"/>
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<section>
<title value="26.1 製造販売元"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="26"/>
</coding>
<text value="26.1 製造販売元"/>
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<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
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<code value="unavailable"/>
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</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Organization/orgchugai"/>
<resource>
<Organization>
<id value="orgchugai"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_orgchugai"> </a><p class="res-header-id"><b>Generated Narrative: Organization orgchugai</b></p><a name="orgchugai"> </a><a name="hcorgchugai"> </a><a name="orgchugai-en-US"> </a><p><b>identifier</b>: <code>https://pmda-org-id</code>/672212 (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>: Chugai 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>Medical Information Department 2-1-1 Nihonbashi Muromachi, Chuo-ku, Tokyo 103-8324(work)</td></tr></table></div>
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<identifier>
<use value="official"/>
<system value="https://pmda-org-id"/>
<value value="672212"/>
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<active value="true"/>
<type>
<coding>
<system value="https://PMDA-org-type.jp/"/>
<code value="tbd"/>
<display value="Marketing authorisation holder"/>
</coding>
<text value="Marketing authorisation holder"/>
</type>
<name value="Chugai Pharmaceutical Co., Ltd."/>
<contact>
<address>
<use value="work"/>
<type value="physical"/>
<text
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<line value="2-1-1 Nihonbashi Muromachi"/>
<city value="Tokyo"/>
<postalCode value="103-8324"/>
<country value="Tokyo"/>
</address>
</contact>
</Organization>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Authorizations/authherceptin150"/>
<resource>
<RegulatedAuthorization>
<id value="authherceptin150"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/RegulatedAuthorization-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_authherceptin150"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization authherceptin150</b></p><a name="authherceptin150"> </a><a name="hcauthherceptin150"> </a><a name="authherceptin150-en-US"> </a><p><b>identifier</b>: <code>https://pmda-approvalandlicenseno/</code>/21300AMY00128 (use: official, )</p><p><b>subject</b>: <a href="MedicinalProductDefinition-medprodherceptin150.html">MedicinalProductDefinition: identifier = http://iyaku.info/medicine#4291447D2024; 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="Organization-orgchugai.html">Organization Chugai Pharmaceutical Co., Ltd.</a></p></div>
</text>
<identifier>
<use value="official"/>
<system value="https://pmda-approvalandlicenseno/"/>
<value value="21300AMY00128"/>
</identifier>
<subject>🔗
<reference value="MedicinalProductDefinition/medprodherceptin150"/>
</subject>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="/#100000072062"/>
</coding>
<text value="Marketing Authorisation"/>
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<region>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="JP"/>
</coding>
<text value="Japan"/>
</region>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
</coding>
<text value="Active"/>
</status>
<statusDate value="2002-08-01T13:28:17Z"/>
<holder>🔗
<reference value="Organization/orgchugai"/>
</holder>
</RegulatedAuthorization>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/MedicinalProductDefinition/medprodherceptin150"/>
<resource>
<MedicinalProductDefinition>
<id value="medprodherceptin150"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_medprodherceptin150"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition medprodherceptin150</b></p><a name="medprodherceptin150"> </a><a name="hcmedprodherceptin150"> </a><a name="medprodherceptin150-en-US"> </a><p><b>identifier</b>: <code>http://iyaku.info/medicine</code>/4291447D2024</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>: Herceptin (trastazumab) 150 mg</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>: Herceptin</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>: trastazumab</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>: 150 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>: Intravenous infusion</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 100000075213}">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>
</text>
<identifier>
<system value="http://iyaku.info/medicine"/>
<value value="4291447D2024"/>
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<type>
<coding>
<system value="http://hl7.org/fhir/medicinal-product-type"/>
<code value="MedicinalProduct"/>
<display value="Medicinal Product"/>
</coding>
</type>
<domain>
<coding>
<system value="http://hl7.org/fhir/medicinal-product-domain"/>
<code value="Human"/>
<display value="Human use"/>
</coding>
</domain>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="active"/>
</coding>
</status>
<legalStatusOfSupply>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072084"/>
<display
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</coding>
</legalStatusOfSupply>
<name>
<productName value="Herceptin (trastazumab) 150 mg"/>
<type>
<coding>
<system value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000001"/>
</coding>
<text value="Full name"/>
</type>
<part>
<part value="Herceptin"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000002"/>
</coding>
<text value="Invented name part"/>
</type>
</part>
<part>
<part value="trastazumab"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000003"/>
</coding>
<text value="Scientific name part"/>
</type>
</part>
<part>
<part value="150 mg"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000004"/>
</coding>
<text value="Strength part"/>
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</part>
<part>
<part value="Intravenous infusion"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="100000075213"/>
</coding>
<text value="Pharmaceutical dose form part"/>
</type>
</part>
<usage>
<country>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="JP"/>
</coding>
</country>
<jurisdiction>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="JP"/>
</coding>
</jurisdiction>
<language>
<coding>
<system value="urn:ietf:bcp:47"/>
<code value="ja-JP"/>
</coding>
</language>
</usage>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/packherceptinvial"/>
<resource>
<PackagedProductDefinition>
<id value="packherceptinvial"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_packherceptinvial"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition packherceptinvial</b></p><a name="packherceptinvial"> </a><a name="hcpackherceptinvial"> </a><a name="packherceptinvial-en-US"> </a><p><b>identifier</b>: <code>https://pmda-packinsertno/</code>/4291012F1022 (use: official, )</p><p><b>name</b>: Herceptin (trastazumab) 150 mg for Intravenous Use</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="MedicinalProductDefinition-medprodherceptin150.html">MedicinalProductDefinition: identifier = http://iyaku.info/medicine#4291447D2024; 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>: 150 mg</p><p><b>manufacturer</b>: <a href="Organization-orgchugai.html">Organization Chugai 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 100000073563}">Vial</span></td><td>28</td><td><span title="Codes:{https://spor.ema.europa.eu/rmswi 200000003204}">Glass type I</span></td></tr></table></div>
</text>
<identifier>
<use value="official"/>
<system value="https://pmda-packinsertno/"/>
<value value="4291012F1022"/>
</identifier>
<name value="Herceptin (trastazumab) 150 mg for Intravenous Use"/>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000155527"/>
<display value="Chemical Medininal Prodcut"/>
</coding>
</type>
<packageFor>🔗
<reference value="MedicinalProductDefinition/medprodherceptin150"/>
</packageFor>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="Active"/>
</coding>
</status>
<statusDate value="2002-08-01T13:28:17Z"/>
<containedItemQuantity>
<value value="150"/>
<unit value="mg"/>
</containedItemQuantity>
<manufacturer>🔗
<reference value="Organization/orgchugai"/>
</manufacturer>
<packaging>
<identifier>
<system value="https://spor.ema.europa.eu/pmswi"/>
<value value="123456"/>
</identifier>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000073563"/>
<display value="Vial"/>
</coding>
</type>
<quantity value="28"/>
<material>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000003204"/>
<display value="Glass type I"/>
</coding>
</material>
</packaging>
</PackagedProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/adminprodherceptin150"/>
<resource>
<AdministrableProductDefinition>
<id value="adminprodherceptin150"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/AdministrableProductDefinition-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="AdministrableProductDefinition_adminprodherceptin150"> </a><p class="res-header-id"><b>Generated Narrative: AdministrableProductDefinition adminprodherceptin150</b></p><a name="adminprodherceptin150"> </a><a name="hcadminprodherceptin150"> </a><a name="adminprodherceptin150-en-US"> </a><p><b>identifier</b>: <code>https://www.who-umc.org/phpid</code>/7532F47F36A3585D1F348BBDDA057862</p><p><b>status</b>: Active</p><p><b>formOf</b>: <a href="MedicinalProductDefinition-medprodherceptin150.html">MedicinalProductDefinition: identifier = http://iyaku.info/medicine#4291447D2024; 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="ManufacturedItemDefinition-manitemherceptin150.html">ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (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>
</text>
<identifier>
<system value="https://www.who-umc.org/phpid"/>
<value value="7532F47F36A3585D1F348BBDDA057862"/>
</identifier>
<status value="active"/>
<formOf>🔗
<reference value="MedicinalProductDefinition/medprodherceptin150"/>
</formOf>
<administrableDoseForm>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="10219000"/>
</coding>
<text value="Tablet"/>
</administrableDoseForm>
<unitOfPresentation>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="15054000"/>
</coding>
</unitOfPresentation>
<producedFrom>🔗
<reference value="ManufacturedItemDefinition/manitemherceptin150"/>
</producedFrom>
<routeOfAdministration>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="20053000"/>
</coding>
</code>
</routeOfAdministration>
</AdministrableProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/ManufacturedItemDefinition/manitemherceptin150"/>
<resource>
<ManufacturedItemDefinition>
<id value="manitemherceptin150"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ManufacturedItemDefinition-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ManufacturedItemDefinition_manitemherceptin150"> </a><p class="res-header-id"><b>Generated Narrative: ManufacturedItemDefinition manitemherceptin150</b></p><a name="manitemherceptin150"> </a><a name="hcmanitemherceptin150"> </a><a name="manitemherceptin150-en-US"> </a><p><b>identifier</b>: <code>https://pmda-sccj</code>/874291 (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="Organization-orgchugai.html">Organization Chugai Pharmaceutical Co., Ltd.</a></p></div>
</text>
<identifier>
<use value="official"/>
<system value="https://pmda-sccj"/>
<value value="874291"/>
</identifier>
<status value="active"/>
<manufacturedDoseForm>
<coding>
<system
value="https://standardterms.edqm.eu/browse/get_concepts_by/SOM/SOM/"/>
<code value="10219000"/>
</coding>
<text value="Tablet"/>
</manufacturedDoseForm>
<unitOfPresentation>
<coding>
<system
value="https://standardterms.edqm.eu/browse/get_concepts/UOP/"/>
<code value="15054000"/>
</coding>
</unitOfPresentation>
<manufacturer>🔗
<reference value="Organization/orgchugai"/>
</manufacturer>
</ManufacturedItemDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/trastazumab"/>
<resource>
<Ingredient>
<id value="trastazumab"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_trastazumab"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient trastazumab</b></p><a name="trastazumab"> </a><a name="hctrastazumab"> </a><a name="trastazumab-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/P188ANX8CK (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-manitemherceptin150.html">ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (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="Organization-orgchugai.html">Organization Chugai 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 P188ANX8CK}">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>150 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>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<value value="P188ANX8CK"/>
</identifier>
<status value="active"/>
<for>🔗
<reference value="ManufacturedItemDefinition/manitemherceptin150"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072072"/>
<display value="Active"/>
</coding>
</role>
<manufacturer>
<manufacturer>🔗
<reference value="Organization/orgchugai"/>
</manufacturer>
</manufacturer>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<code value="P188ANX8CK"/>
<display value="trastazumab"/>
</coding>
</concept>
</code>
<strength>
<presentationQuantity>
<value value="150"/>
<unit value="mg"/>
</presentationQuantity>
<basis>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-RoleClass"/>
<code value="ACTIB"/>
</coding>
<text value="active ingredient - basis of strength"/>
</basis>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/carnubawax"/>
<resource>
<Ingredient>
<id value="carnubawax"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_carnubawax"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient carnubawax</b></p><a name="carnubawax"> </a><a name="hccarnubawax"> </a><a name="carnubawax-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/R12CBM0EIZ (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-manitemherceptin150.html">ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000</a></p><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">Excipient</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-orgchugai.html">Organization Chugai 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/ R12CBM0EIZ}">Carnauba wax</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<value value="R12CBM0EIZ"/>
</identifier>
<status value="active"/>
<for>🔗
<reference value="ManufacturedItemDefinition/manitemherceptin150"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<manufacturer>
<manufacturer>🔗
<reference value="Organization/orgchugai"/>
</manufacturer>
</manufacturer>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<code value="R12CBM0EIZ"/>
<display value="Carnauba wax"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/crystallinecellulose"/>
<resource>
<Ingredient>
<id value="crystallinecellulose"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_crystallinecellulose"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient crystallinecellulose</b></p><a name="crystallinecellulose"> </a><a name="hccrystallinecellulose"> </a><a name="crystallinecellulose-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/OP1R32D61U (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-manitemherceptin150.html">ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000</a></p><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">Excipient</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-orgchugai.html">Organization Chugai 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/ OP1R32D61U}">crystalline cellulose</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<value value="OP1R32D61U"/>
</identifier>
<status value="active"/>
<for>🔗
<reference value="ManufacturedItemDefinition/manitemherceptin150"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<manufacturer>
<manufacturer>🔗
<reference value="Organization/orgchugai"/>
</manufacturer>
</manufacturer>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<code value="OP1R32D61U"/>
<display value="crystalline cellulose"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/mannitol"/>
<resource>
<Ingredient>
<id value="mannitol"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_mannitol"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient mannitol</b></p><a name="mannitol"> </a><a name="hcmannitol"> </a><a name="mannitol-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/3OWL53L36A (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-manitemherceptin150.html">ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000</a></p><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">Excipient</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-orgchugai.html">Organization Chugai 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/ 3OWL53L36A}">MANNITOL</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<value value="3OWL53L36A"/>
</identifier>
<status value="active"/>
<for>🔗
<reference value="ManufacturedItemDefinition/manitemherceptin150"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<manufacturer>
<manufacturer>🔗
<reference value="Organization/orgchugai"/>
</manufacturer>
</manufacturer>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<code value="3OWL53L36A"/>
<display value="MANNITOL"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/hypromelose"/>
<resource>
<Ingredient>
<id value="hypromelose"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_hypromelose"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient hypromelose</b></p><a name="hypromelose"> </a><a name="hchypromelose"> </a><a name="hypromelose-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/3NXW29V3WO (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-manitemherceptin150.html">ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000</a></p><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">Excipient</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-orgchugai.html">Organization Chugai 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/ 3NXW29V3WO}">HYPROMELLOSE, UNSPECIFIED</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<value value="3NXW29V3WO"/>
</identifier>
<status value="active"/>
<for>🔗
<reference value="ManufacturedItemDefinition/manitemherceptin150"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<manufacturer>
<manufacturer>🔗
<reference value="Organization/orgchugai"/>
</manufacturer>
</manufacturer>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<code value="3NXW29V3WO"/>
<display value="HYPROMELLOSE, UNSPECIFIED"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/lightanhydroussilicicacid"/>
<resource>
<Ingredient>
<id value="lightanhydroussilicicacid"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_lightanhydroussilicicacid"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient lightanhydroussilicicacid</b></p><a name="lightanhydroussilicicacid"> </a><a name="hclightanhydroussilicicacid"> </a><a name="lightanhydroussilicicacid-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/ETJ7Z6XBU4 (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-manitemherceptin150.html">ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000</a></p><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">Excipient</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-orgchugai.html">Organization Chugai 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/ ETJ7Z6XBU4}">light anhydrous silicic acid</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<value value="ETJ7Z6XBU4"/>
</identifier>
<status value="active"/>
<for>🔗
<reference value="ManufacturedItemDefinition/manitemherceptin150"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<manufacturer>
<manufacturer>🔗
<reference value="Organization/orgchugai"/>
</manufacturer>
</manufacturer>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<code value="ETJ7Z6XBU4"/>
<display value="light anhydrous silicic acid"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/magnesiumcarbonate"/>
<resource>
<Ingredient>
<id value="magnesiumcarbonate"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_magnesiumcarbonate"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient magnesiumcarbonate</b></p><a name="magnesiumcarbonate"> </a><a name="hcmagnesiumcarbonate"> </a><a name="magnesiumcarbonate-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/0E53J927NA (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-manitemherceptin150.html">ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000</a></p><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">Excipient</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-orgchugai.html">Organization Chugai 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/ 0E53J927NA}">MAGNESIUM CARBONATE</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<value value="0E53J927NA"/>
</identifier>
<status value="active"/>
<for>🔗
<reference value="ManufacturedItemDefinition/manitemherceptin150"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<manufacturer>
<manufacturer>🔗
<reference value="Organization/orgchugai"/>
</manufacturer>
</manufacturer>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<code value="0E53J927NA"/>
<display value="MAGNESIUM CARBONATE"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/magnesiumstearate"/>
<resource>
<Ingredient>
<id value="magnesiumstearate"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_magnesiumstearate"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient magnesiumstearate</b></p><a name="magnesiumstearate"> </a><a name="hcmagnesiumstearate"> </a><a name="magnesiumstearate-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/70097M6I30 (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-manitemherceptin150.html">ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000</a></p><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">Excipient</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-orgchugai.html">Organization Chugai 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/ 70097M6I30}">MAGNESIUM STEARATE</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<value value="70097M6I30"/>
</identifier>
<status value="active"/>
<for>🔗
<reference value="ManufacturedItemDefinition/manitemherceptin150"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<manufacturer>
<manufacturer>🔗
<reference value="Organization/orgchugai"/>
</manufacturer>
</manufacturer>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<code value="70097M6I30"/>
<display value="MAGNESIUM STEARATE"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/methylparaben"/>
<resource>
<Ingredient>
<id value="methylparaben"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_methylparaben"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient methylparaben</b></p><a name="methylparaben"> </a><a name="hcmethylparaben"> </a><a name="methylparaben-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/A2I8C7HI9T (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-manitemherceptin150.html">ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000</a></p><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">Excipient</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-orgchugai.html">Organization Chugai 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/ A2I8C7HI9T}">METHYLPARABEN</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<value value="A2I8C7HI9T"/>
</identifier>
<status value="active"/>
<for>🔗
<reference value="ManufacturedItemDefinition/manitemherceptin150"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<manufacturer>
<manufacturer>🔗
<reference value="Organization/orgchugai"/>
</manufacturer>
</manufacturer>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<code value="A2I8C7HI9T"/>
<display value="METHYLPARABEN"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/polyethyleneglycol"/>
<resource>
<Ingredient>
<id value="polyethyleneglycol"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_polyethyleneglycol"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient polyethyleneglycol</b></p><a name="polyethyleneglycol"> </a><a name="hcpolyethyleneglycol"> </a><a name="polyethyleneglycol-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/30IQX730WE (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-manitemherceptin150.html">ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000</a></p><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">Excipient</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-orgchugai.html">Organization Chugai 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/ 30IQX730WE}">POLYETHYLENE GLYCOL 6000</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<value value="30IQX730WE"/>
</identifier>
<status value="active"/>
<for>🔗
<reference value="ManufacturedItemDefinition/manitemherceptin150"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<manufacturer>
<manufacturer>🔗
<reference value="Organization/orgchugai"/>
</manufacturer>
</manufacturer>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<code value="30IQX730WE"/>
<display value="POLYETHYLENE GLYCOL 6000"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/polysorbate"/>
<resource>
<Ingredient>
<id value="polysorbate"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_polysorbate"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient polysorbate</b></p><a name="polysorbate"> </a><a name="hcpolysorbate"> </a><a name="polysorbate-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/6OZP39ZG8H (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-manitemherceptin150.html">ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000</a></p><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">Excipient</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-orgchugai.html">Organization Chugai 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/ 6OZP39ZG8H}">POLYSORBATE 80</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<value value="6OZP39ZG8H"/>
</identifier>
<status value="active"/>
<for>🔗
<reference value="ManufacturedItemDefinition/manitemherceptin150"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<manufacturer>
<manufacturer>🔗
<reference value="Organization/orgchugai"/>
</manufacturer>
</manufacturer>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<code value="6OZP39ZG8H"/>
<display value="POLYSORBATE 80"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/polyvinylalcohol"/>
<resource>
<Ingredient>
<id value="polyvinylalcohol"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_polyvinylalcohol"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient polyvinylalcohol</b></p><a name="polyvinylalcohol"> </a><a name="hcpolyvinylalcohol"> </a><a name="polyvinylalcohol-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/532B59J990 (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-manitemherceptin150.html">ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000</a></p><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">Excipient</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-orgchugai.html">Organization Chugai 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/ 532B59J990}">POLYVINYL ALCOHOL, UNSPECIFIED</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<value value="532B59J990"/>
</identifier>
<status value="active"/>
<for>🔗
<reference value="ManufacturedItemDefinition/manitemherceptin150"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<manufacturer>
<manufacturer>🔗
<reference value="Organization/orgchugai"/>
</manufacturer>
</manufacturer>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<code value="532B59J990"/>
<display value="POLYVINYL ALCOHOL, UNSPECIFIED"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/sucrose"/>
<resource>
<Ingredient>
<id value="sucrose"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_sucrose"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient sucrose</b></p><a name="sucrose"> </a><a name="hcsucrose"> </a><a name="sucrose-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/C151H8M554 (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-manitemherceptin150.html">ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000</a></p><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">Excipient</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-orgchugai.html">Organization Chugai 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/ C151H8M554}">SUCROSE</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<value value="C151H8M554"/>
</identifier>
<status value="active"/>
<for>🔗
<reference value="ManufacturedItemDefinition/manitemherceptin150"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<manufacturer>
<manufacturer>🔗
<reference value="Organization/orgchugai"/>
</manufacturer>
</manufacturer>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<code value="C151H8M554"/>
<display value="SUCROSE"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/silicondioxide"/>
<resource>
<Ingredient>
<id value="silicondioxide"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_silicondioxide"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient silicondioxide</b></p><a name="silicondioxide"> </a><a name="hcsilicondioxide"> </a><a name="silicondioxide-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/ETJ7Z6XBU4 (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-manitemherceptin150.html">ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000</a></p><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">Excipient</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-orgchugai.html">Organization Chugai 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/ ETJ7Z6XBU4}">SILICON DIOXIDE</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<value value="ETJ7Z6XBU4"/>
</identifier>
<status value="active"/>
<for>🔗
<reference value="ManufacturedItemDefinition/manitemherceptin150"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<manufacturer>
<manufacturer>🔗
<reference value="Organization/orgchugai"/>
</manufacturer>
</manufacturer>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<code value="ETJ7Z6XBU4"/>
<display value="SILICON DIOXIDE"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/sodiumstarch"/>
<resource>
<Ingredient>
<id value="sodiumstarch"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_sodiumstarch"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient sodiumstarch</b></p><a name="sodiumstarch"> </a><a name="hcsodiumstarch"> </a><a name="sodiumstarch-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/5856J3G2A2 (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-manitemherceptin150.html">ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000</a></p><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">Excipient</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-orgchugai.html">Organization Chugai 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/ 5856J3G2A2}">SODIUM STARCH GLYCOLATE TYPE A POTATO</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<value value="5856J3G2A2"/>
</identifier>
<status value="active"/>
<for>🔗
<reference value="ManufacturedItemDefinition/manitemherceptin150"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<manufacturer>
<manufacturer>🔗
<reference value="Organization/orgchugai"/>
</manufacturer>
</manufacturer>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<code value="5856J3G2A2"/>
<display value="SODIUM STARCH GLYCOLATE TYPE A POTATO"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/syntehticwax"/>
<resource>
<Ingredient>
<id value="syntehticwax"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_syntehticwax"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient syntehticwax</b></p><a name="syntehticwax"> </a><a name="hcsyntehticwax"> </a><a name="syntehticwax-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/5M631N9V0S (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-manitemherceptin150.html">ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000</a></p><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">Excipient</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-orgchugai.html">Organization Chugai 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/ 5M631N9V0S}">synthetic wax</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<value value="5M631N9V0S"/>
</identifier>
<status value="active"/>
<for>🔗
<reference value="ManufacturedItemDefinition/manitemherceptin150"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<manufacturer>
<manufacturer>🔗
<reference value="Organization/orgchugai"/>
</manufacturer>
</manufacturer>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<code value="5M631N9V0S"/>
<display value="synthetic wax"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/talc"/>
<resource>
<Ingredient>
<id value="talc"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_talc"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient talc</b></p><a name="talc"> </a><a name="hctalc"> </a><a name="talc-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/7SEV7J4R1U (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-manitemherceptin150.html">ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000</a></p><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">Excipient</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-orgchugai.html">Organization Chugai 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/ 7SEV7J4R1U}">talc</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<value value="7SEV7J4R1U"/>
</identifier>
<status value="active"/>
<for>🔗
<reference value="ManufacturedItemDefinition/manitemherceptin150"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<manufacturer>
<manufacturer>🔗
<reference value="Organization/orgchugai"/>
</manufacturer>
</manufacturer>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<code value="7SEV7J4R1U"/>
<display value="talc"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/titaniumdioxide2"/>
<resource>
<Ingredient>
<id value="titaniumdioxide2"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_titaniumdioxide2"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient titaniumdioxide2</b></p><a name="titaniumdioxide2"> </a><a name="hctitaniumdioxide2"> </a><a name="titaniumdioxide2-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/15FIX9V2JP (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-manitemherceptin150.html">ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000</a></p><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">Excipient</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-orgchugai.html">Organization Chugai 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/ 15FIX9V2JP}">TITANIUM DIOXIDE</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<value value="15FIX9V2JP"/>
</identifier>
<status value="active"/>
<for>🔗
<reference value="ManufacturedItemDefinition/manitemherceptin150"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<manufacturer>
<manufacturer>🔗
<reference value="Organization/orgchugai"/>
</manufacturer>
</manufacturer>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<code value="15FIX9V2JP"/>
<display value="TITANIUM DIOXIDE"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/subherceptin150"/>
<resource>
<SubstanceDefinition>
<id value="subherceptin150"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_subherceptin150"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition subherceptin150</b></p><a name="subherceptin150"> </a><a name="hcsubherceptin150"> </a><a name="subherceptin150-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/P188ANX8CK (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>
</div><p><b>manufacturer</b>: <a href="Organization-orgchugai.html">Organization Chugai 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>C20H24O2</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>trastazumab</td><td><span title="Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta/ 1}">Chemical Name</span></td></tr></table></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<value value="P188ANX8CK"/>
</identifier>
<version value="39"/>
<status>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<code value="1"/>
</coding>
<text value="Validated (UNII)"/>
</status>
<description value="White to pale yellow"/>
<manufacturer>🔗
<reference value="Organization/orgchugai"/>
</manufacturer>
<structure>
<molecularFormula value="C20H24O2"/>
</structure>
<name>
<name value="trastazumab"/>
<type>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<code value="1"/>
</coding>
<text value="Chemical Name"/>
</type>
</name>
</SubstanceDefinition>
</resource>
</entry>
</Bundle>