Miscellaneous ePI Test
0.1.0 - CI Build
Miscellaneous ePI Test
0.1.0 - CI Build
Miscellaneous ePI Test, published by . This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/cander2/epi-test/ and changes regularly. See the Directory of published versions
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<div xmlns="http://www.w3.org/1999/xhtml" xml:lang="ja" lang="ja"><a name="Composition_compositionsimvastatin20jpi"> </a><p><b>Generated Narrative: Composition</b><a name="compositionsimvastatin20jpi"> </a><a name="hccompositionsimvastatin20jpi"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Composition "compositionsimvastatin20jpi" (Language "ja") </p><p style="margin-bottom: 0px">Profile: <a href="https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Composition-uv-epi.html">Composition (ePI)</a></p></div><p><b>identifier</b>: <code>https://spor.ema.europa.eu/rmswi/</code>/fcats34placeholder</p><p><b>status</b>: final</p><p><b>type</b>: Package Leaflet <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#100000155538)</span></p><p><b>date</b>: 2002-08-01 13:28:17+0000</p><p><b>author</b>: <a href="Organization-orgchugai.html">Organization/orgchugai</a> "Chugai Pharmaceutical Co., Ltd."</p><p><b>title</b>: simvastatin20 Package Leaflet - 150 mg for Intravenous Use</p><h3>Attesters</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Mode</b></td><td><b>Time</b></td></tr><tr><td style="display: none">*</td><td>Official <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-composition-attestation-mode.html">Composition Attestation Mode</a>#official)</span></td><td>2002-08-01 13:28:17+0000</td></tr></table></div>
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<subject>🔗
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<title value="15.1"/>
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<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</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"/>
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<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
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<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"/>
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<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
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<section>
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<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="13"/>
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<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
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</section>
</section>
<section>
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<code>
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<code value="17"/>
</coding>
<text value="17. 臨床成績"/>
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<text>
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<section>
<title value="17.1 有効性及び安全性に関する試験"/>
<code>
<coding>
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<code value="13"/>
</coding>
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<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
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<section>
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<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="13"/>
</coding>
<text value="17.1.1 国内臨床試験"/>
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<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
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<section>
<title value="17.1.2 ブリッジング試験"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="13"/>
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<text value="17.1.2 ブリッジング試験"/>
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<text>
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<div xmlns="http://www.w3.org/1999/xhtml"></div>
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<code>
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<system value="https://pmda.jp/"/>
<code value="13"/>
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<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</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)"/>
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<code value="13"/>
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<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
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<code value="13"/>
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<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
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</section>
<section>
<title
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<code>
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<code value="16"/>
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</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
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</section>
</section>
</section>
<section>
<title value="18. 薬効薬理"/>
<code>
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<code value="18"/>
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<text value="18. 薬効薬理"/>
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<section>
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<code>
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<text value="18.1 作用機序"/>
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<text>
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<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"/>
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<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
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</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"/>
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<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
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</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"></div>
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<section>
<title value="18.3.1"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="17"/>
</coding>
<text value="18.3.1"/>
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<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
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<section>
<title value="18.3.2"/>
<code>
<coding>
<system value="https://pmda.jp/"/>
<code value="17"/>
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<text value="18.3.2"/>
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<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
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</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"/>
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<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</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"></div>
</text>
</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"></div>
</text>
</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"></div>
</text>
</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"></div>
</text>
</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"></div>
</text>
</section>
<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"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</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"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</section>
<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"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</section>
</Composition>
</resource>
</entry>
<entry>
<fullUrl value="Organization/orgohara"/>
<resource>
<Organization>
<id value="orgohara"/>
<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_orgohara"> </a><p><b>Generated Narrative: Organization</b><a name="orgohara"> </a><a name="hcorgohara"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Organization "orgohara" </p><p style="margin-bottom: 0px">Profile: <a href="https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Organization-uv-epi.html">Organization (ePI)</a></p></div><p><b>identifier</b>: <code>https://pmda-org-id</code>/sim672212 (use: official)</p><p><b>active</b>: true</p><p><b>type</b>: Marketing authorisation holder <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#tbd)</span></p><p><b>name</b>: Ohara Pharmaceutical Co., Ltd.</p><h3>Contacts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Address</b></td></tr><tr><td style="display: none">*</td><td>15 Nihonbashi Muromachi, Chuo-ku, Tokyo 8324(work)</td></tr></table></div>
</text>
<identifier>
<use value="official"/>
<system value="https://pmda-org-id"/>
<value value="sim672212"/>
</identifier>
<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="Ohara Pharmaceutical Co., Ltd."/>
<contact>
<address>
<use value="work"/>
<type value="physical"/>
<text value="15 Nihonbashi Muromachi, Chuo-ku, Tokyo 8324"/>
<line value="15 Nihonbashi Muromachi"/>
<city value="Tokyo"/>
<postalCode value="8324"/>
<country value="Tokyo"/>
</address>
</contact>
</Organization>
</resource>
</entry>
<entry>
<fullUrl value="Authorizations/authsimvastatin20"/>
<resource>
<RegulatedAuthorization>
<id value="authsimvastatin20"/>
<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_authsimvastatin20"> </a><p><b>Generated Narrative: RegulatedAuthorization</b><a name="authsimvastatin20"> </a><a name="hcauthsimvastatin20"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource RegulatedAuthorization "authsimvastatin20" </p><p style="margin-bottom: 0px">Profile: <a href="https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-RegulatedAuthorization-uv-epi.html">RegulatedAuthorization (ePI)</a></p></div><p><b>identifier</b>: <code>https://pmda-approvalandlicenseno/</code>/21300AMY00128 (use: official)</p><p><b>subject</b>: See on this page: MedicinalProductDefinition/medprodsimvastatin20</p><p><b>type</b>: Marketing Authorisation <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#/#100000072062)</span></p><p><b>region</b>: Japan <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-ISO3166Part1.html">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#jp)</span></p><p><b>status</b>: Active <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-publication-status.html">PublicationStatus</a>#active)</span></p><p><b>statusDate</b>: 2002-08-01 13:28:17+0000</p><p><b>holder</b>: See on this page: Organization/orgohara</p></div>
</text>
<identifier>
<use value="official"/>
<system value="https://pmda-approvalandlicenseno/"/>
<value value="21300AMY00128"/>
</identifier>
<subject>🔗
<reference value="MedicinalProductDefinition/medprodsimvastatin20"/>
</subject>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="/#100000072062"/>
</coding>
<text value="Marketing Authorisation"/>
</type>
<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/orgohara"/>
</holder>
</RegulatedAuthorization>
</resource>
</entry>
<entry>
<fullUrl value="MedicinalProductDefinition/medprodsimvastatin20"/>
<resource>
<MedicinalProductDefinition>
<id value="medprodsimvastatin20"/>
<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_medprodsimvastatin20"> </a><p><b>Generated Narrative: MedicinalProductDefinition</b><a name="medprodsimvastatin20"> </a><a name="hcmedprodsimvastatin20"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource MedicinalProductDefinition "medprodsimvastatin20" </p><p style="margin-bottom: 0px">Profile: <a href="https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-MedicinalProductDefinition-uv-epi.html">MedicinalProductDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>http://www.pmda.jp/</code>/sim874291</p><p><b>type</b>: Medicinal Product <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-medicinal-product-type.html">Medicinal Product Type</a>#MedicinalProduct)</span></p><p><b>domain</b>: Human use <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-medicinal-product-domain.html">Medicinal Product Domain</a>#Human)</span></p><p><b>status</b>: active <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-publication-status.html">PublicationStatus</a>#active)</span></p><p><b>legalStatusOfSupply</b>: Medicinal product subject to medical prescription <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#100000072084)</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Simvastatin 20 mg tablets</p><p><b>type</b>: Full name <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (220000000000#220000000001)</span></p><blockquote><p><b>part</b></p><p><b>part</b>: Simvastatin</p><p><b>type</b>: Invented name part <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (220000000000#220000000002)</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: Simvastatin</p><p><b>type</b>: Scientific name part <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (220000000000#220000000003)</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 20 mg</p><p><b>type</b>: Strength part <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (220000000000#220000000004)</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: tablet</p><p><b>type</b>: Pharmaceutical dose form part <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (220000000000#220000000005)</span></p></blockquote><h3>Usages</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Country</b></td><td><b>Jurisdiction</b></td><td><b>Language</b></td></tr><tr><td style="display: none">*</td><td>Japan <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-ISO3166Part1.html">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#JP)</span></td><td>Japan <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-ISO3166Part1.html">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#JP)</span></td><td>JA <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-v3-ietf3066.html">Tags for the Identification of Languages</a>#JA)</span></td></tr></table></blockquote></div>
</text>
<identifier>
<system value="http://www.pmda.jp/"/>
<value value="sim874291"/>
</identifier>
<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
value="Medicinal product subject to medical prescription"/>
</coding>
</legalStatusOfSupply>
<name>
<productName value="Simvastatin 20 mg tablets"/>
<type>
<coding>
<system value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000001"/>
</coding>
<text value="Full name"/>
</type>
<part>
<part value="Simvastatin"/>
<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="Simvastatin"/>
<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="20 mg"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000004"/>
</coding>
<text value="Strength part"/>
</type>
</part>
<part>
<part value="tablet"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000005"/>
</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"/>
</coding>
</language>
</usage>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
<entry>
<fullUrl value="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><b>Generated Narrative: PackagedProductDefinition</b><a name="packherceptinvial"> </a><a name="hcpackherceptinvial"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource PackagedProductDefinition "packherceptinvial" </p><p style="margin-bottom: 0px">Profile: <a href="https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-PackagedProductDefinition-uv-epi.html">PackagedProductDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>https://pmda-packinsertno/</code>/4291012F1022 (use: official)</p><p><b>name</b>: Herceptin (trastazumab) 150 mg for Intravenous Use</p><p><b>type</b>: Chemical Medininal Prodcut <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#100000155527)</span></p><p><b>packageFor</b>: <a href="MedicinalProductDefinition-medprodherceptin150.html">MedicinalProductDefinition/medprodherceptin150</a></p><p><b>status</b>: Active <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-publication-status.html">PublicationStatus</a>#active)</span></p><p><b>statusDate</b>: 2002-08-01 13:28:17+0000</p><p><b>containedItemQuantity</b>: 150 mg</p><p><b>manufacturer</b>: <a href="Organization-orgchugai.html">Organization/orgchugai</a> "Chugai Pharmaceutical Co., Ltd."</p><h3>Packagings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Identifier</b></td><td><b>Type</b></td><td><b>Quantity</b></td><td><b>Material</b></td></tr><tr><td style="display: none">*</td><td><code>https://spor.ema.europa.eu/pmswi</code>/123456</td><td>Vial <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#100000073563)</span></td><td>28</td><td>Glass type I <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#200000003204)</span></td></tr></table></div>
</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="AdministrableProductDefinition/adminprodsimvastatin20"/>
<resource>
<AdministrableProductDefinition>
<id value="adminprodsimvastatin20"/>
<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_adminprodsimvastatin20"> </a><p><b>Generated Narrative: AdministrableProductDefinition</b><a name="adminprodsimvastatin20"> </a><a name="hcadminprodsimvastatin20"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource AdministrableProductDefinition "adminprodsimvastatin20" </p><p style="margin-bottom: 0px">Profile: <a href="https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-AdministrableProductDefinition-uv-epi.html">AdministrableProductDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>https://www.who-umc.org/phpid</code>/9721571303255BF02181E8EC5AD60DF9</p><p><b>status</b>: active</p><p><b>formOf</b>: See on this page: MedicinalProductDefinition/medprodsimvastatin20</p><p><b>administrableDoseForm</b>: Tablet <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#10219000)</span></p><p><b>unitOfPresentation</b>: 15054000 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#15054000)</span></p><p><b>producedFrom</b>: See on this page: ManufacturedItemDefinition/manitemsimvastatin20</p><h3>RouteOfAdministrations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td></tr><tr><td style="display: none">*</td><td>20053000 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#20053000)</span></td></tr></table></div>
</text>
<identifier>
<system value="https://www.who-umc.org/phpid"/>
<value value="9721571303255BF02181E8EC5AD60DF9"/>
</identifier>
<status value="active"/>
<formOf>🔗
<reference value="MedicinalProductDefinition/medprodsimvastatin20"/>
</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/manitemsimvastatin20"/>
</producedFrom>
<routeOfAdministration>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="20053000"/>
</coding>
</code>
</routeOfAdministration>
</AdministrableProductDefinition>
</resource>
</entry>
<entry>
<fullUrl value="ManufacturedItemDefinition/manitemsimvastatin20"/>
<resource>
<ManufacturedItemDefinition>
<id value="manitemsimvastatin20"/>
<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_manitemsimvastatin20"> </a><p><b>Generated Narrative: ManufacturedItemDefinition</b><a name="manitemsimvastatin20"> </a><a name="hcmanitemsimvastatin20"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ManufacturedItemDefinition "manitemsimvastatin20" </p><p style="margin-bottom: 0px">Profile: <a href="https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-ManufacturedItemDefinition-uv-epi.html">ManufacturedItemDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>https://pmda-sccj</code>/sim874291 (use: official)</p><p><b>status</b>: active</p><p><b>manufacturedDoseForm</b>: Tablet <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#10219000)</span></p><p><b>unitOfPresentation</b>: 15054000 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#15054000)</span></p><p><b>manufacturer</b>: See on this page: Organization/orgohara</p></div>
</text>
<identifier>
<use value="official"/>
<system value="https://pmda-sccj"/>
<value value="sim874291"/>
</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/orgohara"/>
</manufacturer>
</ManufacturedItemDefinition>
</resource>
</entry>
<entry>
<fullUrl value="Ingredient/ingredientsimvastatin20"/>
<resource>
<Ingredient>
<id value="ingredientsimvastatin20"/>
<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_ingredientsimvastatin20"> </a><p><b>Generated Narrative: Ingredient</b><a name="ingredientsimvastatin20"> </a><a name="hcingredientsimvastatin20"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Ingredient "ingredientsimvastatin20" </p><p style="margin-bottom: 0px">Profile: <a href="https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Ingredient-uv-epi.html">Ingredient (ePI)</a></p></div><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/AGG2FN16EV (use: official)</p><p><b>status</b>: active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-manitemherceptin150.html">ManufacturedItemDefinition/manitemherceptin150</a></p><p><b>role</b>: Active <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#100000072072)</span></p><h3>Manufacturers</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Manufacturer</b></td></tr><tr><td style="display: none">*</td><td>See on this page: Organization/orgohara</td></tr></table><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td>trastazumab <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (beta#AGG2FN16EV)</span></td></tr></table><h3>Strengths</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Presentation[x]</b></td><td><b>Basis</b></td></tr><tr><td style="display: none">*</td><td>20 mg</td><td>active ingredient - basis of strength <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-v3-RoleClass.html">RoleClass</a>#ACTIB)</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<value value="AGG2FN16EV"/>
</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/orgohara"/>
</manufacturer>
</manufacturer>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<code value="AGG2FN16EV"/>
<display value="trastazumab"/>
</coding>
</concept>
</code>
<strength>
<presentationQuantity>
<value value="20"/>
<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="SubstanceDefinition/subsimvastatin20"/>
<resource>
<SubstanceDefinition>
<id value="subsimvastatin20"/>
<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_subsimvastatin20"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name="subsimvastatin20"> </a><a name="hcsubsimvastatin20"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource SubstanceDefinition "subsimvastatin20" </p><p style="margin-bottom: 0px">Profile: <a href="https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-SubstanceDefinition-uv-epi.html">SubstanceDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/AGG2FN16EV (use: official)</p><p><b>version</b>: 39</p><p><b>status</b>: Validated (UNII) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#1)</span></p><p><b>description</b>: White to pale yellow</p><p><b>manufacturer</b>: See on this page: Organization/orgohara</p><h3>Structures</h3><table class="grid"><tr><td style="display: none">-</td><td><b>MolecularFormula</b></td></tr><tr><td style="display: none">*</td><td>C25H38O5</td></tr></table><h3>Names</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td>simvastatin</td><td>Chemical Name <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#1)</span></td></tr></table></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<value value="AGG2FN16EV"/>
</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/orgohara"/>
</manufacturer>
<structure>
<molecularFormula value="C25H38O5"/>
</structure>
<name>
<name value="simvastatin"/>
<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>
IG © 2022+ . Package hl7.fhir.uv.epi-test#0.1.0 based on FHIR 5.0.0. Generated 2024-04-04
Links: Table of Contents |
QA Report
The Gravitate Health project has received funding from the IMI 2 Joint Undertaking under grant agreement No 945334.
This joint undertaking receives support from the EU H2020 research and innovation programme and EFPIA.
