CH EPL (R5)
0.1.0 - ci-build
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
<Bundle xmlns="http://hl7.org/fhir">
<id value="b2eb19be-cca4-4fd8-a2a3-84d05631e6c0"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-bundle"/>
</meta>
<type value="collection"/>
<entry>
<fullUrl
value="http://example.org/MedicinalProductDefinition/Keytruda-100mg-Vial"/>
<resource>
<MedicinalProductDefinition>
<id value="Keytruda-100mg-Vial"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-medicinalproductdefinition"/>
</meta>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_Keytruda-100mg-Vial"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition Keytruda-100mg-Vial</b></p><a name="Keytruda-100mg-Vial"> </a><a name="hcKeytruda-100mg-Vial"> </a><a name="Keytruda-100mg-Vial-en-US"> </a><p><b>CH - SMC Authorized Dose Form</b>: <span title="Codes:{urn:oid:0.4.0.127.0.16.1.1.2.1 11213000}">Concentrate for solution for infusion</span></p><p><b>CH - EPL Full Limitation Text</b>: 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</p><p><b>identifier</b>: <code>http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID</code>/CH-7601001001138-6623101</p><p><b>domain</b>: <span title="Codes:{urn:oid:1.2.276.0.76 100000000012}">Human</span></p><p><b>indication</b>: </p><div><p>xxxxxxx</p>
</div><p><b>legalStatusOfSupply</b>: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply 756005022001}">One-time dispensation on medical or veterinary prescription (A)</span></p><p><b>classification</b>: <span title="Codes:{http://www.whocc.no/atc G03FA01}">norethisterone and estrogen</span>, <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-therapeuticproductcode BT}">Biotechnologika</span></p><p><b>attachedDocument</b>: <a href="DocumentReference-DocRef-FI-Keytruda.html">DocumentReference: status = current; type = Fachinformation</a></p><blockquote><p><b>name</b></p><p><b>productName</b>: KEYTRUDA Inf Konz 100 mg/4ml</p><p><b>type</b>: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-medicinal-product-name-type SMC}">Swissmedic</span></p><h3>Usages</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Country</b></td><td><b>Language</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{urn:iso:std:iso:3166 CH}">Switzerland</span></td><td><span title="Codes:{urn:ietf:bcp:47 de-CH}">German (Switzerland)</span></td></tr></table></blockquote></div>
</text>
<extension
url="http://fhir.ch/ig/ch-epl/StructureDefinition/authorizedDoseForm">
<valueCodeableConcept>
<coding>
<system value="urn:oid:0.4.0.127.0.16.1.1.2.1"/>
<code value="11213000"/>
<display value="Concentrate for solution for infusion"/>
</coding>
</valueCodeableConcept>
</extension>
<extension
url="http://fhir.ch/ig/ch-epl/StructureDefinition/fullLimitationText">
<valueString
value="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"/>
</extension>
<identifier>
<system
value="http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID"/>
<value value="CH-7601001001138-6623101"/>
</identifier>
<domain>
<coding>
<system value="urn:oid:1.2.276.0.76"/>
<code value="100000000012"/>
<display value="Human"/>
</coding>
</domain>
<indication value="xxxxxxx"/>
<legalStatusOfSupply>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply"/>
<code value="756005022001"/>
<display
value="One-time dispensation on medical or veterinary prescription (A)"/>
</coding>
</legalStatusOfSupply>
<classification>
<coding>
<system value="http://www.whocc.no/atc"/>
<code value="G03FA01"/>
</coding>
</classification>
<classification>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-therapeuticproductcode"/>
<code value="BT"/>
<display value="Biotechnologika"/>
</coding>
</classification>
<attachedDocument>🔗
<reference value="DocumentReference/DocRef-FI-Keytruda"/>
</attachedDocument>
<name>
<productName value="KEYTRUDA Inf Konz 100 mg/4ml"/>
<type>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-medicinal-product-name-type"/>
<code value="SMC"/>
<display value="Swissmedic"/>
</coding>
</type>
<usage>
<country>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="CH"/>
<display value="Switzerland"/>
</coding>
</country>
<language>
<coding>
<system value="urn:ietf:bcp:47"/>
<code value="de-CH"/>
<display value="German (Switzerland)"/>
</coding>
</language>
</usage>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/DocumentReference/DocRef-FI-Keytruda"/>
<resource>
<DocumentReference>
<id value="DocRef-FI-Keytruda"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-documentreference"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="DocumentReference_DocRef-FI-Keytruda"> </a><p class="res-header-id"><b>Generated Narrative: DocumentReference DocRef-FI-Keytruda</b></p><a name="DocRef-FI-Keytruda"> </a><a name="hcDocRef-FI-Keytruda"> </a><a name="DocRef-FI-Keytruda-en-US"> </a><p><b>status</b>: Current</p><p><b>type</b>: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-attached-document-type FI}">Fachinformation</span></p><blockquote><p><b>content</b></p><h3>Attachments</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://swissmedicinfo.ch/showTextAccepted.aspx?textType=FI&lang=DE&authNr=66231&supportMultipleResults=1">https://swissmedicinfo.ch/showTextAccepted.aspx?textType=FI&lang=DE&authNr=66231&supportMultipleResults=1</a></td></tr></table></blockquote></div>
</text>
<status value="current"/>
<type>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-attached-document-type"/>
<code value="FI"/>
<display value="Fachinformation"/>
</coding>
</type>
<content>
<attachment>
<url
value="https://swissmedicinfo.ch/showTextAccepted.aspx?textType=FI&lang=DE&authNr=66231&supportMultipleResults=1"/>
</attachment>
</content>
</DocumentReference>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/RegulatedAuthorisation/MA-6623101"/>
<resource>
<RegulatedAuthorization>
<id value="MA-6623101"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_MA-6623101"> </a><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>
</text>
<contained>
<Organization>
<id value="holder-MSD-Merck-Sharp-Dohme-AG"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"/>
</meta>
<identifier>
<system value="urn:oid:1.2.276.0.76"/>
<value value="100080484"/>
</identifier>
<identifier>
<system value="urn:oid:2.51.1.3"/>
<value value="7601001001138"/>
</identifier>
<name value="MSD Merck Sharp & Dohme AG"/>
</Organization>
</contained>
<contained>
<Organization>
<id value="regulator-SMC"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"/>
</meta>
<identifier>
<system value="urn:oid:1.2.276.0.76"/>
<value value="100010911"/>
</identifier>
<identifier>
<system value="urn:oid:2.51.1.3"/>
<value value="7601001398511"/>
</identifier>
<name value="SMC"/>
</Organization>
</contained>
<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"/>
</coding>
</status>
<statusDate value="2022-02-17"/>
<holder>
<reference value="#holder-MSD-Merck-Sharp-Dohme-AG"/>
</holder>
<regulator>
<reference value="#regulator-SMC"/>
</regulator>
</RegulatedAuthorization>
</resource>
</entry>
<entry>
<fullUrl
value="http://example.org/PackagedProductDefinition/PMP-Keytruda-100mg-4ml-Solution-for-Infusion"/>
<resource>
<PackagedProductDefinition>
<id value="PMP-Keytruda-100mg-4ml-Solution-for-Infusion"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-packagedproductdefinition"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_PMP-Keytruda-100mg-4ml-Solution-for-Infusion"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition PMP-Keytruda-100mg-4ml-Solution-for-Infusion</b></p><a name="PMP-Keytruda-100mg-4ml-Solution-for-Infusion"> </a><a name="hcPMP-Keytruda-100mg-4ml-Solution-for-Infusion"> </a><a name="PMP-Keytruda-100mg-4ml-Solution-for-Infusion-en-US"> </a><p><b>identifier</b>: <code>http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID</code>/CH-7601001001138-6623101-001</p><p><b>packageFor</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>description</b>: </p><div><p>KEYTRUDA Inf Konz 100 mg/4ml Durchstf</p>
</div><h3>LegalStatusOfSupplies</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:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply 756005022001}">One-time dispensation on medical or veterinary prescription (A)</span></td></tr></table><blockquote><p><b>packaging</b></p><p><b>identifier</b>: <code>urn:oid:2.51.1.1</code>/7680662310018</p><p><b>type</b>: <span title="Codes:{urn:oid:0.4.0.127.0.16.1.1.2.1 30009000}">Box</span></p><p><b>quantity</b>: 1</p><h3>ShelfLifeStorages</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>SpecialPrecautionsForStorage</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{urn:oid:1.2.276.0.76 100000073403}">Shelf life of the medicinal product as packaged for sale</span></td><td><span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-special-precautions-for-storage 2}">Im Kühlschrank (2°C - 8°C)</span></td></tr><tr><td style="display: none">*</td><td> </td><td><span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-special-precautions-for-storage L}">vor Licht Schützen</span></td></tr><tr><td style="display: none">*</td><td> </td><td><span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-special-precautions-for-storage NF}">Nicht einfrieren</span></td></tr><tr><td style="display: none">*</td><td> </td><td><span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-special-precautions-for-storage OVP}">In der Originalverpackung aufbewahren.</span></td></tr></table></blockquote></div>
</text>
<identifier>
<system
value="http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID"/>
<value value="CH-7601001001138-6623101-001"/>
</identifier>
<packageFor>🔗
<reference value="MedicinalProductDefinition/Keytruda-100mg-Vial"/>
</packageFor>
<description value="KEYTRUDA Inf Konz 100 mg/4ml Durchstf"/>
<legalStatusOfSupply>
<code>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply"/>
<code value="756005022001"/>
<display
value="One-time dispensation on medical or veterinary prescription (A)"/>
</coding>
</code>
</legalStatusOfSupply>
<packaging>
<identifier>
<system value="urn:oid:2.51.1.1"/>
<value value="7680662310018"/>
</identifier>
<type>
<coding>
<system value="urn:oid:0.4.0.127.0.16.1.1.2.1"/>
<code value="30009000"/>
<display value="Box"/>
</coding>
</type>
<quantity value="1"/>
<shelfLifeStorage>
<type>
<coding>
<system value="urn:oid:1.2.276.0.76"/>
<code value="100000073403"/>
<display
value="Shelf life of the medicinal product as packaged for sale"/>
</coding>
</type>
<specialPrecautionsForStorage>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-special-precautions-for-storage"/>
<code value="2"/>
<display value="Im Kühlschrank (2°C - 8°C)"/>
</coding>
</specialPrecautionsForStorage>
</shelfLifeStorage>
<shelfLifeStorage>
<specialPrecautionsForStorage>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-special-precautions-for-storage"/>
<code value="L"/>
<display value="vor Licht Schützen"/>
</coding>
</specialPrecautionsForStorage>
</shelfLifeStorage>
<shelfLifeStorage>
<specialPrecautionsForStorage>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-special-precautions-for-storage"/>
<code value="NF"/>
<display value="Nicht einfrieren"/>
</coding>
</specialPrecautionsForStorage>
</shelfLifeStorage>
<shelfLifeStorage>
<specialPrecautionsForStorage>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-special-precautions-for-storage"/>
<code value="OVP"/>
<display value="In der Originalverpackung aufbewahren."/>
</coding>
</specialPrecautionsForStorage>
</shelfLifeStorage>
</packaging>
</PackagedProductDefinition>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/RegulatedAuthorisation/MA-66231001"/>
<resource>
<RegulatedAuthorization>
<id value="MA-66231001"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_MA-66231001"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization MA-66231001</b></p><a name="MA-66231001"> </a><a name="hcMA-66231001"> </a><a name="MA-66231001-en-US"> </a><p><b>identifier</b>: <code>http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber</code>/66231001</p><p><b>subject</b>: <a href="PackagedProductDefinition-PMP-Keytruda-100mg-4ml-Solution-for-Infusion.html">PackagedProductDefinition: identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID#CH-7601001001138-6623101-001; description = KEYTRUDA Inf Konz 100 mg/4ml Durchstf</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-66231001/holder-MSD-Merck-Sharp-Dohme-AG">Organization MSD Merck Sharp & Dohme AG</a></p><p><b>regulator</b>: <a href="#hcMA-66231001/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-66231001/holder-MSD-Merck-Sharp-Dohme-AG"> </a><a name="hcMA-66231001/holder-MSD-Merck-Sharp-Dohme-AG"> </a><a name="MA-66231001/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-66231001/regulator-SMC"> </a><a name="hcMA-66231001/regulator-SMC"> </a><a name="MA-66231001/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>
</text>
<contained>
<Organization>
<id value="holder-MSD-Merck-Sharp-Dohme-AG"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"/>
</meta>
<identifier>
<system value="urn:oid:1.2.276.0.76"/>
<value value="100080484"/>
</identifier>
<identifier>
<system value="urn:oid:2.51.1.3"/>
<value value="7601001001138"/>
</identifier>
<name value="MSD Merck Sharp & Dohme AG"/>
</Organization>
</contained>
<contained>
<Organization>
<id value="regulator-SMC"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"/>
</meta>
<identifier>
<system value="urn:oid:1.2.276.0.76"/>
<value value="100010911"/>
</identifier>
<identifier>
<system value="urn:oid:2.51.1.3"/>
<value value="7601001398511"/>
</identifier>
<name value="SMC"/>
</Organization>
</contained>
<identifier>
<system
value="http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber"/>
<value value="66231001"/>
</identifier>
<subject>🔗
<reference
value="PackagedProductDefinition/PMP-Keytruda-100mg-4ml-Solution-for-Infusion"/>
</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"/>
</coding>
</status>
<statusDate value="2022-02-17"/>
<holder>
<reference value="#holder-MSD-Merck-Sharp-Dohme-AG"/>
</holder>
<regulator>
<reference value="#regulator-SMC"/>
</regulator>
</RegulatedAuthorization>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/RegulatedAuthorisation/FOPH-20416"/>
<resource>
<RegulatedAuthorization>
<id value="FOPH-20416"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_FOPH-20416"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization FOPH-20416</b></p><a name="FOPH-20416"> </a><a name="hcFOPH-20416"> </a><a name="FOPH-20416-en-US"> </a><blockquote><p><b>CH - EPL Reimbursement SL</b></p><ul><li>FOPHDossierNumber: <code>urn:oid:2.16.756.1</code>/20416</li><li>status: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-reimbursement-status 756001021001}">Reimbursed</span></li><li>statusDate: 2023-01-01</li><li>expiryDate: 2025-03-31</li><li>listingStatus: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-listing-status 756001002001}">Listed</span></li><li>listingPeriod: 2023-01-01 --> 2024-12-31</li><li>firstListingDate: 2017-09-01</li><li>costShare: 10</li><li>gamme: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-gamme 756002004009}">Parenteral Depot</span></li></ul></blockquote><blockquote><p><b>CH - EPL Product Price</b></p><ul><li>value: <span title="Swiss Franc">CHF4,407.68</span> (CHF)</li><li>type: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type 756002005002}">Ex-factory price</span></li><li>changeType: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change 756002006006}">Normal price mutation</span></li><li>changeDate: 2023-01-01</li></ul></blockquote><blockquote><p><b>CH - EPL Product Price</b></p><ul><li>value: <span title="Swiss Franc">CHF4,768.50</span> (CHF)</li><li>type: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type 756002005001}">Retail price</span></li><li>changeType: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change 756002006005}">VAT-change</span></li><li>changeDate: 2024-01-01</li></ul></blockquote><p><b>subject</b>: <a href="PackagedProductDefinition-PMP-Keytruda-100mg-4ml-Solution-for-Infusion.html">PackagedProductDefinition: identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID#CH-7601001001138-6623101-001; description = KEYTRUDA Inf Konz 100 mg/4ml Durchstf</a></p><p><b>type</b>: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type 756000002003}">Reimbursement SL</span></p><h3>Indications</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td/><td><a href="ClinicalUseDefinition-IND-10075566.html">ClinicalUseDefinition: type = indication</a></td></tr></table><p><b>holder</b>: <a href="#hcFOPH-20416/holder-MSD-Merck-Sharp-Dohme-AG">Organization MSD Merck Sharp & Dohme AG</a></p><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Organization #holder-MSD-Merck-Sharp-Dohme-AG</b></p><a name="FOPH-20416/holder-MSD-Merck-Sharp-Dohme-AG"> </a><a name="hcFOPH-20416/holder-MSD-Merck-Sharp-Dohme-AG"> </a><a name="FOPH-20416/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></div>
</text>
<contained>
<Organization>
<id value="holder-MSD-Merck-Sharp-Dohme-AG"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"/>
</meta>
<identifier>
<system value="urn:oid:1.2.276.0.76"/>
<value value="100080484"/>
</identifier>
<identifier>
<system value="urn:oid:2.51.1.3"/>
<value value="7601001001138"/>
</identifier>
<name value="MSD Merck Sharp & Dohme AG"/>
</Organization>
</contained>
<extension
url="http://fhir.ch/ig/ch-epl/StructureDefinition/reimbursementSL">
<extension url="FOPHDossierNumber">
<valueIdentifier>
<system value="urn:oid:2.16.756.1"/>
<value value="20416"/>
</valueIdentifier>
</extension>
<extension url="status">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-reimbursement-status"/>
<code value="756001021001"/>
<display value="Reimbursed"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="statusDate">
<valueDate value="2023-01-01"/>
</extension>
<extension url="expiryDate">
<valueDate value="2025-03-31"/>
</extension>
<extension url="listingStatus">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-listing-status"/>
<code value="756001002001"/>
<display value="Listed"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="listingPeriod">
<valuePeriod>
<start value="2023-01-01"/>
<end value="2024-12-31"/>
</valuePeriod>
</extension>
<extension url="firstListingDate">
<valueDate value="2017-09-01"/>
</extension>
<extension url="costShare">
<valueInteger value="10"/>
</extension>
<extension url="gamme">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-gamme"/>
<code value="756002004009"/>
<display value="Parenteral Depot"/>
</coding>
</valueCodeableConcept>
</extension>
</extension>
<extension
url="http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice">
<extension url="value">
<valueMoney>
<value value="4407.68"/>
<currency value="CHF"/>
</valueMoney>
</extension>
<extension url="type">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type"/>
<code value="756002005002"/>
<display value="Ex-factory price"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="changeType">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change"/>
<code value="756002006006"/>
<display value="Normal price mutation"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="changeDate">
<valueDate value="2023-01-01"/>
</extension>
</extension>
<extension
url="http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice">
<extension url="value">
<valueMoney>
<value value="4768.5"/>
<currency value="CHF"/>
</valueMoney>
</extension>
<extension url="type">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type"/>
<code value="756002005001"/>
<display value="Retail price"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="changeType">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change"/>
<code value="756002006005"/>
<display value="VAT-change"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="changeDate">
<valueDate value="2024-01-01"/>
</extension>
</extension>
<subject>🔗
<reference
value="PackagedProductDefinition/PMP-Keytruda-100mg-4ml-Solution-for-Infusion"/>
</subject>
<type>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type"/>
<code value="756000002003"/>
<display value="Reimbursement SL"/>
</coding>
</type>
<indication>
<extension
url="http://fhir.ch/ig/ch-epl/StructureDefinition/regulatedAuthorization-limitation">
<extension url="status">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-limitationstatus"/>
<code value="756002071001"/>
<display value="Limitation Reimbursed"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="statusDate">
<valueDate value="2023-01-01"/>
</extension>
<extension url="period">
<valuePeriod>
<start value="2023-01-01"/>
<end value="2024-12-31"/>
</valuePeriod>
</extension>
<extension url="reimbursementEndDate">
<valueDate value="2025-03-31"/>
</extension>
<extension url="firstLimitationDate">
<valueDate value="2023-01-01"/>
</extension>
<extension url="indicationCode">
<valueString value="20416.17"/>
</extension>
<extension url="limitationIndication">
<valueReference>🔗
<reference value="ClinicalUseDefinition/LIM-254837009"/>
</valueReference>
</extension>
<extension
url="http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice">
<extension url="value">
<valueMoney>
<value value="4407.68"/>
<currency value="CHF"/>
</valueMoney>
</extension>
<extension url="type">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type"/>
<code value="756002005002"/>
<display value="Ex-factory price"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="changeType">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change"/>
<code value="756002006006"/>
<display value="Normal price mutation"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="changeDate">
<valueDate value="2023-01-01"/>
</extension>
</extension>
<extension
url="http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice">
<extension url="value">
<valueMoney>
<value value="4768.5"/>
<currency value="CHF"/>
</valueMoney>
</extension>
<extension url="type">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type"/>
<code value="756002005001"/>
<display value="Retail price"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="changeType">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change"/>
<code value="756002006005"/>
<display value="VAT-change"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="changeDate">
<valueDate value="2024-01-01"/>
</extension>
</extension>
</extension>
<reference>🔗
<reference value="ClinicalUseDefinition/IND-10075566"/>
</reference>
</indication>
<holder>
<reference value="#holder-MSD-Merck-Sharp-Dohme-AG"/>
</holder>
</RegulatedAuthorization>
</resource>
</entry>
<entry>
<fullUrl
value="http://example.org/ManufacturedItemDefinition/MI-Pembrolizumab-100mg-Vial"/>
<resource>
<ManufacturedItemDefinition>
<id value="MI-Pembrolizumab-100mg-Vial"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-manufactureditemdefinition"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ManufacturedItemDefinition_MI-Pembrolizumab-100mg-Vial"> </a><p class="res-header-id"><b>Generated Narrative: ManufacturedItemDefinition MI-Pembrolizumab-100mg-Vial</b></p><a name="MI-Pembrolizumab-100mg-Vial"> </a><a name="hcMI-Pembrolizumab-100mg-Vial"> </a><a name="MI-Pembrolizumab-100mg-Vial-en-US"> </a><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title="Codes:{urn:oid:0.4.0.127.0.16.1.1.2.1 10221000}">Film-coated tablet</span></p><p><b>unitOfPresentation</b>: <span title="Codes:{urn:oid:0.4.0.127.0.16.1.1.2.1 15060000}">Vial</span></p></div>
</text>
<status value="active"/>
<manufacturedDoseForm>
<coding>
<system value="urn:oid:0.4.0.127.0.16.1.1.2.1"/>
<code value="10221000"/>
<display value="Film-coated tablet"/>
</coding>
</manufacturedDoseForm>
<unitOfPresentation>
<coding>
<system value="urn:oid:0.4.0.127.0.16.1.1.2.1"/>
<code value="15060000"/>
<display value="Vial"/>
</coding>
</unitOfPresentation>
</ManufacturedItemDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://example.org/AdministrableProductDefinition/PhP-Pembrolizumab-100mg-Vial"/>
<resource>
<AdministrableProductDefinition>
<id value="PhP-Pembrolizumab-100mg-Vial"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-administrableproductdefinition"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="AdministrableProductDefinition_PhP-Pembrolizumab-100mg-Vial"> </a><p class="res-header-id"><b>Generated Narrative: AdministrableProductDefinition PhP-Pembrolizumab-100mg-Vial</b></p><a name="PhP-Pembrolizumab-100mg-Vial"> </a><a name="hcPhP-Pembrolizumab-100mg-Vial"> </a><a name="PhP-Pembrolizumab-100mg-Vial-en-US"> </a><p><b>status</b>: Active</p><p><b>formOf</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>administrableDoseForm</b>: <span title="Codes:{urn:oid:0.4.0.127.0.16.1.1.2.1 11210000}">Solution for infusion</span></p><p><b>unitOfPresentation</b>: <span title="Codes:{urn:oid:0.4.0.127.0.16.1.1.2.1 15060000}">Vial</span></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:{urn:oid:0.4.0.127.0.16.1.1.2.1 20045000}">Intravenous use</span></td></tr></table></div>
</text>
<status value="active"/>
<formOf>🔗
<reference value="MedicinalProductDefinition/Keytruda-100mg-Vial"/>
</formOf>
<administrableDoseForm>
<coding>
<system value="urn:oid:0.4.0.127.0.16.1.1.2.1"/>
<code value="11210000"/>
<display value="Solution for infusion"/>
</coding>
</administrableDoseForm>
<unitOfPresentation>
<coding>
<system value="urn:oid:0.4.0.127.0.16.1.1.2.1"/>
<code value="15060000"/>
<display value="Vial"/>
</coding>
</unitOfPresentation>
<routeOfAdministration>
<code>
<coding>
<system value="urn:oid:0.4.0.127.0.16.1.1.2.1"/>
<code value="20045000"/>
<display value="Intravenous use"/>
</coding>
</code>
</routeOfAdministration>
</AdministrableProductDefinition>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/Ingredient/Pembrolizumab100"/>
<resource>
<Ingredient>
<id value="Pembrolizumab100"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-ingredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_Pembrolizumab100"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient Pembrolizumab100</b></p><a name="Pembrolizumab100"> </a><a name="hcPembrolizumab100"> </a><a name="Pembrolizumab100-en-US"> </a><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="AdministrableProductDefinition-PhP-Pembrolizumab-100mg-Vial.html">AdministrableProductDefinition: status = active; administrableDoseForm = Solution for infusion; unitOfPresentation = Vial</a></li><li><a href="ManufacturedItemDefinition-MI-Pembrolizumab-100mg-Vial.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Vial</a></li></ul><p><b>role</b>: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-ingredient-role WIRKS}">Wirkstoff</span></p><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:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-substance DPT0O3T46P}">Pembrolizumab</span></td></tr></table><h3>Strengths</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Presentation[x]</b></td></tr><tr><td style="display: none">*</td><td>100 mg<span style="background: LightGoldenRodYellow"> (Details: UCUM codemg = 'mg')</span>/1 Vial<span style="background: LightGoldenRodYellow"> (Details: EDQM - Standard Terms code15060000 = 'Vial')</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference
value="AdministrableProductDefinition/PhP-Pembrolizumab-100mg-Vial"/>
</for>
<for>🔗
<reference
value="ManufacturedItemDefinition/MI-Pembrolizumab-100mg-Vial"/>
</for>
<role>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-ingredient-role"/>
<code value="WIRKS"/>
<display value="Wirkstoff"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-substance"/>
<code value="DPT0O3T46P"/>
<display value="Pembrolizumab"/>
</coding>
</concept>
</code>
<strength>
<presentationRatio>
<numerator>
<value value="100"/>
<unit value="mg"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="Vial"/>
<system value="urn:oid:0.4.0.127.0.16.1.1.2.1"/>
<code value="15060000"/>
</denominator>
</presentationRatio>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/ClinicalUseDefinition/IND-10027400"/>
<resource>
<ClinicalUseDefinition>
<id value="IND-10027400"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-clinicalusedefinition-indication"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ClinicalUseDefinition_IND-10027400"> </a><p class="res-header-id"><b>Generated Narrative: ClinicalUseDefinition IND-10027400</b></p><a name="IND-10027400"> </a><a name="hcIND-10027400"> </a><a name="IND-10027400-en-US"> </a><p><b>type</b>: Indication</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><blockquote><p><b>indication</b></p><h3>DiseaseSymptomProcedures</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://www.meddra.org 10027400}">Melanom</span></td></tr></table><h3>IntendedEffects</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:{urn:oid:1.2.276.0.76 200000003194}">therapeutic</span></td></tr></table></blockquote></div>
</text>
<type value="indication"/>
<subject>🔗
<reference value="MedicinalProductDefinition/Keytruda-100mg-Vial"/>
</subject>
<indication>
<diseaseSymptomProcedure>
<concept>
<coding>
<system value="https://www.meddra.org"/>
<code value="10027400"/>
<display value="Melanom"/>
</coding>
</concept>
</diseaseSymptomProcedure>
<intendedEffect>
<concept>
<coding>
<system value="urn:oid:1.2.276.0.76"/>
<code value="200000003194"/>
<display value="therapeutic"/>
</coding>
</concept>
</intendedEffect>
</indication>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/ClinicalUseDefinition/IND-10075566"/>
<resource>
<ClinicalUseDefinition>
<id value="IND-10075566"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-clinicalusedefinition-indication"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ClinicalUseDefinition_IND-10075566"> </a><p class="res-header-id"><b>Generated Narrative: ClinicalUseDefinition IND-10075566</b></p><a name="IND-10075566"> </a><a name="hcIND-10075566"> </a><a name="IND-10075566-en-US"> </a><p><b>type</b>: Indication</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><blockquote><p><b>indication</b></p><h3>DiseaseSymptomProcedures</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://www.meddra.org 10075566}">Triple negative breast cancer</span></td></tr></table><h3>IntendedEffects</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:{urn:oid:1.2.276.0.76 200000003194}">therapeutic</span></td></tr></table></blockquote></div>
</text>
<type value="indication"/>
<subject>🔗
<reference value="MedicinalProductDefinition/Keytruda-100mg-Vial"/>
</subject>
<indication>
<diseaseSymptomProcedure>
<concept>
<coding>
<system value="https://www.meddra.org"/>
<code value="10075566"/>
<display value="Triple negative breast cancer"/>
</coding>
</concept>
</diseaseSymptomProcedure>
<intendedEffect>
<concept>
<coding>
<system value="urn:oid:1.2.276.0.76"/>
<code value="200000003194"/>
<display value="therapeutic"/>
</coding>
</concept>
</intendedEffect>
</indication>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/ClinicalUseDefinition/IND-10028881"/>
<resource>
<ClinicalUseDefinition>
<id value="IND-10028881"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-clinicalusedefinition-indication"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ClinicalUseDefinition_IND-10028881"> </a><p class="res-header-id"><b>Generated Narrative: ClinicalUseDefinition IND-10028881</b></p><a name="IND-10028881"> </a><a name="hcIND-10028881"> </a><a name="IND-10028881-en-US"> </a><p><b>type</b>: Indication</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><blockquote><p><b>indication</b></p><h3>DiseaseSymptomProcedures</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://www.meddra.org 10028881}">Nicht-kleinzelliges Lungenkarzinom</span></td></tr></table><h3>IntendedEffects</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:{urn:oid:1.2.276.0.76 200000003194}">therapeutic</span></td></tr></table></blockquote></div>
</text>
<type value="indication"/>
<subject>🔗
<reference value="MedicinalProductDefinition/Keytruda-100mg-Vial"/>
</subject>
<indication>
<diseaseSymptomProcedure>
<concept>
<coding>
<system value="https://www.meddra.org"/>
<code value="10028881"/>
<display value="Nicht-kleinzelliges Lungenkarzinom"/>
</coding>
</concept>
</diseaseSymptomProcedure>
<intendedEffect>
<concept>
<coding>
<system value="urn:oid:1.2.276.0.76"/>
<code value="200000003194"/>
<display value="therapeutic"/>
</coding>
</concept>
</intendedEffect>
</indication>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/ClinicalUseDefinition/IND-10021782"/>
<resource>
<ClinicalUseDefinition>
<id value="IND-10021782"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-clinicalusedefinition-indication"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ClinicalUseDefinition_IND-10021782"> </a><p class="res-header-id"><b>Generated Narrative: ClinicalUseDefinition IND-10021782</b></p><a name="IND-10021782"> </a><a name="hcIND-10021782"> </a><a name="IND-10021782-en-US"> </a><p><b>type</b>: Indication</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><blockquote><p><b>indication</b></p><h3>DiseaseSymptomProcedures</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://www.meddra.org 10021782}">Kopf- und Halskarzinom</span></td></tr></table><h3>IntendedEffects</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:{urn:oid:1.2.276.0.76 200000003194}">therapeutic</span></td></tr></table></blockquote></div>
</text>
<type value="indication"/>
<subject>🔗
<reference value="MedicinalProductDefinition/Keytruda-100mg-Vial"/>
</subject>
<indication>
<diseaseSymptomProcedure>
<concept>
<coding>
<system value="https://www.meddra.org"/>
<code value="10021782"/>
<display value="Kopf- und Halskarzinom"/>
</coding>
</concept>
</diseaseSymptomProcedure>
<intendedEffect>
<concept>
<coding>
<system value="urn:oid:1.2.276.0.76"/>
<code value="200000003194"/>
<display value="therapeutic"/>
</coding>
</concept>
</intendedEffect>
</indication>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/ClinicalUseDefinition/IND-10019927"/>
<resource>
<ClinicalUseDefinition>
<id value="IND-10019927"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-clinicalusedefinition-indication"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ClinicalUseDefinition_IND-10019927"> </a><p class="res-header-id"><b>Generated Narrative: ClinicalUseDefinition IND-10019927</b></p><a name="IND-10019927"> </a><a name="hcIND-10019927"> </a><a name="IND-10019927-en-US"> </a><p><b>type</b>: Indication</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><blockquote><p><b>indication</b></p><h3>DiseaseSymptomProcedures</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://www.meddra.org 10019927}">Klassisches Hodgkin Lymphom</span></td></tr></table><h3>IntendedEffects</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:{urn:oid:1.2.276.0.76 200000003194}">therapeutic</span></td></tr></table></blockquote></div>
</text>
<type value="indication"/>
<subject>🔗
<reference value="MedicinalProductDefinition/Keytruda-100mg-Vial"/>
</subject>
<indication>
<diseaseSymptomProcedure>
<concept>
<coding>
<system value="https://www.meddra.org"/>
<code value="10019927"/>
<display value="Klassisches Hodgkin Lymphom"/>
</coding>
</concept>
</diseaseSymptomProcedure>
<intendedEffect>
<concept>
<coding>
<system value="urn:oid:1.2.276.0.76"/>
<code value="200000003194"/>
<display value="therapeutic"/>
</coding>
</concept>
</intendedEffect>
</indication>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/ClinicalUseDefinition/IND-10043971"/>
<resource>
<ClinicalUseDefinition>
<id value="IND-10043971"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-clinicalusedefinition-indication"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ClinicalUseDefinition_IND-10043971"> </a><p class="res-header-id"><b>Generated Narrative: ClinicalUseDefinition IND-10043971</b></p><a name="IND-10043971"> </a><a name="hcIND-10043971"> </a><a name="IND-10043971-en-US"> </a><p><b>type</b>: Indication</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><blockquote><p><b>indication</b></p><h3>DiseaseSymptomProcedures</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://www.meddra.org 10043971}">Primäres mediastinales grosszelliges B-Zell-Lymphom</span></td></tr></table><h3>IntendedEffects</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:{urn:oid:1.2.276.0.76 200000003194}">therapeutic</span></td></tr></table></blockquote></div>
</text>
<type value="indication"/>
<subject>🔗
<reference value="MedicinalProductDefinition/Keytruda-100mg-Vial"/>
</subject>
<indication>
<diseaseSymptomProcedure>
<concept>
<coding>
<system value="https://www.meddra.org"/>
<code value="10043971"/>
<display
value="Primäres mediastinales grosszelliges B-Zell-Lymphom"/>
</coding>
</concept>
</diseaseSymptomProcedure>
<intendedEffect>
<concept>
<coding>
<system value="urn:oid:1.2.276.0.76"/>
<code value="200000003194"/>
<display value="therapeutic"/>
</coding>
</concept>
</intendedEffect>
</indication>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/ClinicalUseDefinition/LIM-254837009"/>
<resource>
<ClinicalUseDefinition>
<id value="LIM-254837009"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ClinicalUseDefinition_LIM-254837009"> </a><p class="res-header-id"><b>Generated Narrative: ClinicalUseDefinition LIM-254837009</b></p><a name="LIM-254837009"> </a><a name="hcLIM-254837009"> </a><a name="LIM-254837009-en-US"> </a><p><b>type</b>: Indication</p><blockquote><p><b>indication</b></p><h3>DiseaseSymptomProcedures</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:{http://snomed.info/sct 254837009}">Malignant tumor of breast</span></td></tr></table><h3>IntendedEffects</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:{urn:oid:1.2.276.0.76 200000003194}">therapeutic</span></td></tr></table></blockquote></div>
</text>
<type value="indication"/>
<indication>
<diseaseSymptomProcedure>
<concept>
<coding>
<system value="http://snomed.info/sct"/>
<code value="254837009"/>
<display value="Malignant tumor of breast"/>
</coding>
</concept>
</diseaseSymptomProcedure>
<intendedEffect>
<concept>
<coding>
<system value="urn:oid:1.2.276.0.76"/>
<code value="200000003194"/>
<display value="therapeutic"/>
</coding>
</concept>
</intendedEffect>
</indication>
</ClinicalUseDefinition>
</resource>
</entry>
</Bundle>