CH EPL (R5)
0.1.0 - ci-build
CH EPL (R5), published by Federal Office of Public Health FOPH. 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/bag-epl/bag-epl-fhir/ and changes regularly. See the Directory of published versions
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<id value="MA-6623101"/>
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<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization MA-6623101</b></p><a name="MA-6623101"> </a><a name="hcMA-6623101"> </a><a name="MA-6623101-en-US"> </a><p><b>identifier</b>: <code>http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber</code>/6623101</p><p><b>subject</b>: <a href="MedicinalProductDefinition-Keytruda-100mg-Vial.html">MedicinalProductDefinition: extension = Concentrate for solution for infusion,Lokal rezidiverendes, nicht resezierbares oder metastasiertes triple-negatives Mammakarzinom (in Kombination mit Chemotherapie) KN 355
(mit Preismodell). KEYTRUDA in Kombination mit Chemotherapie zur Behandlung des lokal rezidivierenden, nicht resezierbaren oder metastasierten triple-negativen Mammakarzinoms bei Erwachsenen, deren Tumore PD-L1 mit einem CPS ≥10 exprimieren und die keine vorherige Chemotherapie bei metastasierter Erkrankung erhalten haben.
- Falls Patienten vorhergehend systemisch im (neo)adjuvanten Setting behandelt wurden: Mit Vortherapie auf Antrazyklin-Basis, ausser diese war kontraindiziert.
- Ohne Therapie mit Checkpoint-Inhibitoren innerhalb der letzten 12 Monate.
Folgender Code ist an den Krankenversicherer zu übermitteln: 20416.17; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001001138-6623101; domain = Human; indication = xxxxxxx; legalStatusOfSupply = One-time dispensation on medical or veterinary prescription (A); classification = norethisterone and estrogen,Biotechnologika</a></p><p><b>type</b>: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type 756000002001}">Marketing Authorisation</span></p><p><b>region</b>: <span title="Codes:{urn:iso:std:iso:3166 CH}">Switzerland</span></p><p><b>status</b>: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-status Z}">zugelassen</span></p><p><b>statusDate</b>: 2022-02-17</p><p><b>holder</b>: <a href="#hcMA-6623101/holder-MSD-Merck-Sharp-Dohme-AG">Organization MSD Merck Sharp & Dohme AG</a></p><p><b>regulator</b>: <a href="#hcMA-6623101/regulator-SMC">Organization SMC</a></p><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Organization #holder-MSD-Merck-Sharp-Dohme-AG</b></p><a name="MA-6623101/holder-MSD-Merck-Sharp-Dohme-AG"> </a><a name="hcMA-6623101/holder-MSD-Merck-Sharp-Dohme-AG"> </a><a name="MA-6623101/holder-MSD-Merck-Sharp-Dohme-AG-en-US"> </a><p><b>identifier</b>: <code>urn:oid:1.2.276.0.76</code>/100080484, <a href="https://www.gs1.org/standards/id-keys/gln" title="Global Location Number">GLN</a>/7601001001138</p><p><b>name</b>: MSD Merck Sharp & Dohme AG</p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Organization #regulator-SMC</b></p><a name="MA-6623101/regulator-SMC"> </a><a name="hcMA-6623101/regulator-SMC"> </a><a name="MA-6623101/regulator-SMC-en-US"> </a><p><b>identifier</b>: <code>urn:oid:1.2.276.0.76</code>/100010911, <a href="https://www.gs1.org/standards/id-keys/gln" title="Global Location Number">GLN</a>/7601001398511</p><p><b>name</b>: SMC</p></blockquote></div>
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<value value="100080484"/>
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<name value="MSD Merck Sharp & Dohme AG"/>
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<id value="regulator-SMC"/>
<meta>
<profile
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<value value="100010911"/>
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<identifier>
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<value value="7601001398511"/>
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<name value="SMC"/>
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<identifier>
<system
value="http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber"/>
<value value="6623101"/>
</identifier>
<subject>🔗
<reference value="MedicinalProductDefinition/Keytruda-100mg-Vial"/>
</subject>
<type>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type"/>
<code value="756000002001"/>
<display value="Marketing Authorisation"/>
</coding>
</type>
<region>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="CH"/>
<display value="Switzerland"/>
</coding>
</region>
<status>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-status"/>
<code value="Z"/>
<display value="zugelassen"/>
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<statusDate value="2022-02-17"/>
<holder>
<reference value="#holder-MSD-Merck-Sharp-Dohme-AG"/>
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<regulator>
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