CH IDMP (R5)
1.0.0-ballot - trial-use
CH IDMP (R5)
1.0.0-ballot - trial-use
CH IDMP (R5) - Local Development build (v1.0.0-ballot) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
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<language value="de-CH"/>
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<entry>
<fullUrl
value="http://fhir.ch-idmp.smc.admin.ch/MedicinalProductDefinition/Padcev-20mg-Powder"/>
<resource>
<MedicinalProductDefinition>
<id value="Padcev-20mg-Powder"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-medicinalproductdefinition"/>
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<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_Padcev-20mg-Powder"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition Padcev-20mg-Powder</b></p><a name="Padcev-20mg-Powder"> </a><a name="hcPadcev-20mg-Powder"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ch-idmp-medicinalproductdefinition.html">MedicinalProductDefinition</a></p></div><p><b>CH SMC - Authorized Dose Form</b>: <span title="Codes:{http://standardterms.edqm.eu 11215000}">Lyophilisate for solution for infusion</span></p><p><b>identifier</b>: <a href="NamingSystem-MPID.html" title="Temporary Identifier in this implementation guide until officially released by Swissmedic">Medical Product Identifier</a>/CH-01100869-0682910030000</p><p><b>indication</b>: </p><div><p>Padcev ist indiziert zur Behandlung von Erwachsenen mit lokal fortgeschrittenem oder metastasiertem Urothelkarzinom (mUC), die eine platinhaltige Chemotherapie im neoadjuvanten/adjuvanten, lokal fortgeschrittenen oder metastasierten Setting erhalten haben und die während oder nach der Behandlung mit einem Inhibitor des programmierten Zelltodrezeptors-1 (PD-1) oder des programmierten Zelltod-Liganden 1 (PD-L1) einen Progress oder einen Rückfall der Erkrankung erlitten haben.</p>
</div><p><b>legalStatusOfSupply</b>: <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-legal-status-of-supply 756005034000001}">A: Single dispensing requiring a medical or veterinary prescription</span></p><p><b>additionalMonitoringIndicator</b>: <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-additional-monitoring-indicator 756005001003}">No Warning</span></p><p><b>pediatricUseIndicator</b>: <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-pediatric-use-indicator 756005003002}">Not authorised for the treatment in children</span></p><p><b>classification</b>: <span title="Codes:{http://www.whocc.no/atc L01EX13}">gilteritinib</span>, <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-authorisation-category 756005011000005}">NA KAS art. 12 para. 5 TPLO</span>, <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-MedicinalProductCategory 756005039000003}">Biologics</span></p><h3>MarketingStatuses</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Country</b></td><td><b>Status</b></td><td><b>DateRange</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:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-marketing-status 7560050074000003}">No interruption of distribution reported</span></td><td>2011-09-11 --> (ongoing)</td></tr></table><p><b>attachedDocument</b>: <a href="DocumentReference-DocRef-FI-Padcev.html">DocumentReference: identifier = http://fhir.ch/ig/ch-idmp/sid/attno#Application / Assessment Tracking Number#123456989-initial submission-Example-xyz-321; status = current; type = Information for healthcare professionals; date = 2021-11-09 00:00:00+0000</a></p><blockquote><p><b>name</b></p><p><b>productName</b>: Padcev 20 mg, Pulver für ein Konzentrat zur Herstellung einer Infusionslösung</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-idmp/StructureDefinition/authorizedDoseForm">
<valueCodeableConcept>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="11215000"/>
<display value="Lyophilisate for solution for infusion"/>
</coding>
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</extension>
<identifier>
<system value="http://fhir.ch/ig/ch-idmp/sid/mpid"/>
<value value="CH-01100869-0682910030000"/>
</identifier>
<indication
value="Padcev ist indiziert zur Behandlung von Erwachsenen mit lokal fortgeschrittenem oder metastasiertem Urothelkarzinom (mUC), die eine platinhaltige Chemotherapie im neoadjuvanten/adjuvanten, lokal fortgeschrittenen oder metastasierten Setting erhalten haben und die während oder nach der Behandlung mit einem Inhibitor des programmierten Zelltodrezeptors-1 (PD-1) oder des programmierten Zelltod-Liganden 1 (PD-L1) einen Progress oder einen Rückfall der Erkrankung erlitten haben."/>
<legalStatusOfSupply>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-legal-status-of-supply"/>
<code value="756005034000001"/>
<display
value="A: Single dispensing requiring a medical or veterinary prescription"/>
</coding>
</legalStatusOfSupply>
<additionalMonitoringIndicator>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-additional-monitoring-indicator"/>
<code value="756005001003"/>
<display value="No Warning"/>
</coding>
</additionalMonitoringIndicator>
<pediatricUseIndicator>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-pediatric-use-indicator"/>
<code value="756005003002"/>
<display value="Not authorised for the treatment in children"/>
</coding>
</pediatricUseIndicator>
<classification>
<coding>
<system value="http://www.whocc.no/atc"/>
<code value="L01EX13"/>
</coding>
</classification>
<classification>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-authorisation-category"/>
<code value="756005011000005"/>
<display value="NA KAS art. 12 para. 5 TPLO"/>
</coding>
</classification>
<classification>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-MedicinalProductCategory"/>
<code value="756005039000003"/>
<display value="Biologics"/>
</coding>
</classification>
<marketingStatus>
<country>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="CH"/>
<display value="Switzerland"/>
</coding>
</country>
<status>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-marketing-status"/>
<code value="7560050074000003"/>
<display value="No interruption of distribution reported"/>
</coding>
</status>
<dateRange>
<start value="2011-09-11"/>
</dateRange>
</marketingStatus>
<attachedDocument>🔗
<reference value="DocumentReference/DocRef-FI-Padcev"/>
</attachedDocument>
<name>
<productName
value="Padcev 20 mg, Pulver für ein Konzentrat zur Herstellung einer Infusionslösung"/>
<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"/>
</coding>
</language>
</usage>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://fhir.ch-idmp.smc.admin.ch/DocumentReference/DocRef-FI-Padcev"/>
<resource>
<DocumentReference>
<id value="DocRef-FI-Padcev"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-documentreference"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="DocumentReference_DocRef-FI-Padcev"> </a><p class="res-header-id"><b>Generated Narrative: DocumentReference DocRef-FI-Padcev</b></p><a name="DocRef-FI-Padcev"> </a><a name="hcDocRef-FI-Padcev"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ch-idmp-documentreference.html">DocumentReference</a></p></div><p><b>identifier</b>: <a href="NamingSystem-AttNo.html" title="Temporary Namingsystem in this implementation guide until officially released by Swissmedic">Application / Assessment Tracking Number</a>/123456989-initial submission-Example-xyz-321</p><p><b>status</b>: Current</p><p><b>type</b>: <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-attached-document-type 756005040000001}">Information for healthcare professionals</span></p><p><b>date</b>: 2021-11-09 00:00:00+0000</p><blockquote><p><b>content</b></p><h3>Attachments</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Language</b></td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td>German (Switzerland)</td><td><a href="https://Swissmedicinfo.ch/showText.aspx?textType=FI&lang=DE&authNr=68291&supportMultipleResults=1">https://Swissmedicinfo.ch/showText.aspx?textType=FI&lang=DE&authNr=68291&supportMultipleResults=1</a></td></tr></table></blockquote></div>
</text>
<identifier>
<system value="http://fhir.ch/ig/ch-idmp/sid/attno"/>
<value value="123456989-initial submission-Example-xyz-321"/>
</identifier>
<status value="current"/>
<type>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-attached-document-type"/>
<code value="756005040000001"/>
<display value="Information for healthcare professionals"/>
</coding>
</type>
<date value="2021-11-09T00:00:00Z"/>
<content>
<attachment>
<language value="de-CH"/>
<url
value="https://Swissmedicinfo.ch/showText.aspx?textType=FI&lang=DE&authNr=68291&supportMultipleResults=1"/>
</attachment>
</content>
</DocumentReference>
</resource>
</entry>
<entry>
<fullUrl
value="http://fhir.ch-idmp.smc.admin.ch/RegulatedAuthorisation/MA-6829103"/>
<resource>
<RegulatedAuthorization>
<id value="MA-6829103"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-regulatedauthorization"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_MA-6829103"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization MA-6829103</b></p><a name="MA-6829103"> </a><a name="hcMA-6829103"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ch-idmp-regulatedauthorization.html">RegulatedAuthorization</a></p></div><p><b>identifier</b>: <a href="NamingSystem-AuthNo.html" title="Temporary Identifier in this implementation guide until officially released by Swissmedic">Marketing Authorisation Number</a>/6829103</p><p><b>subject</b>: <a href="MedicinalProductDefinition-Padcev-20mg-Powder.html">MedicinalProductDefinition: extension = Lyophilisate for solution for infusion; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#Medical Product Identifier#CH-01100869-0682910030000; indication = Padcev ist indiziert zur Behandlung von Erwachsenen mit lokal fortgeschrittenem oder metastasiertem Urothelkarzinom (mUC), die eine platinhaltige Chemotherapie im neoadjuvanten/adjuvanten, lokal fortgeschrittenen oder metastasierten Setting erhalten haben und die während oder nach der Behandlung mit einem Inhibitor des programmierten Zelltodrezeptors-1 (PD-1) oder des programmierten Zelltod-Liganden 1 (PD-L1) einen Progress oder einen Rückfall der Erkrankung erlitten haben.; legalStatusOfSupply = A: Single dispensing requiring a medical or veterinary prescription; additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Not authorised for the treatment in children; classification = gilteritinib,NA KAS art. 12 para. 5 TPLO,Biologics</a></p><p><b>type</b>: <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-authorisation-type-cs 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-idmp/CodeSystem/ch-SMC-authorisation-status 756005010000001}">approved</span></p><p><b>statusDate</b>: 2021-11-09</p><p><b>validityPeriod</b>: 2021-11-09 --> 2026-11-08</p><p><b>holder</b>: <a href="#hcMA-6829103/holder-Astellas-Pharma-AG">Organization Astellas Pharma AG</a></p><p><b>regulator</b>: <a href="#hcMA-6829103/regulator-SMC">Organization SMC</a></p><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Organization #holder-Astellas-Pharma-AG</b></p><a name="MA-6829103/holder-Astellas-Pharma-AG"> </a><a name="hcMA-6829103/holder-Astellas-Pharma-AG"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ch-idmp-organization.html">Organization</a></p></div><p><b>identifier</b>: <a href="NamingSystem-SMCLocID.html" title="Temporary NamingSystem in this implementation guide until officially released by Swissmedic">Swissmedic Location Identifier</a>/01100869, <a href="NamingSystem-LOC.html" title="Identifier holding a number for LocID (Location Identifier of the European Medicines Agency - Organisation Management System OMS)">LOC Identifier</a>/100010745, <a href="NamingSystem-GLN.html" title="Identifier holding a number for GLN (Global Location Number)">GLN Identifier</a>/7601001000964</p><p><b>name</b>: Astellas Pharma AG</p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Organization #regulator-SMC</b></p><a name="MA-6829103/regulator-SMC"> </a><a name="hcMA-6829103/regulator-SMC"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ch-idmp-organization.html">Organization</a></p></div><p><b>identifier</b>: <a href="NamingSystem-LOC.html" title="Identifier holding a number for LocID (Location Identifier of the European Medicines Agency - Organisation Management System OMS)">LOC Identifier</a>/100010911, <a href="NamingSystem-GLN.html" title="Identifier holding a number for GLN (Global Location Number)">GLN Identifier</a>/7601001398511</p><p><b>name</b>: SMC</p></blockquote></div>
</text>
<contained>
<Organization>
<id value="holder-Astellas-Pharma-AG"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization"/>
</meta>
<identifier>
<system
value="https://www.swissmedic.ch/fhir/identifier/locations"/>
<value value="01100869"/>
</identifier>
<identifier>
<system value="https://spor.ema.europa.eu/v1/locations"/>
<value value="100010745"/>
</identifier>
<identifier>
<system value="urn:oid:2.51.1.3"/>
<value value="7601001000964"/>
</identifier>
<name value="Astellas Pharma AG"/>
</Organization>
</contained>
<contained>
<Organization>
<id value="regulator-SMC"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization"/>
</meta>
<identifier>
<system value="https://spor.ema.europa.eu/v1/locations"/>
<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://fhir.ch/ig/ch-idmp/sid/authno"/>
<value value="6829103"/>
</identifier>
<subject>🔗
<reference value="MedicinalProductDefinition/Padcev-20mg-Powder"/>
</subject>
<type>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-authorisation-type-cs"/>
<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-idmp/CodeSystem/ch-SMC-authorisation-status"/>
<code value="756005010000001"/>
<display value="approved"/>
</coding>
</status>
<statusDate value="2021-11-09"/>
<validityPeriod>
<start value="2021-11-09"/>
<end value="2026-11-08"/>
</validityPeriod>
<holder>
<reference value="#holder-Astellas-Pharma-AG"/>
</holder>
<regulator>
<reference value="#regulator-SMC"/>
</regulator>
</RegulatedAuthorization>
</resource>
</entry>
<entry>
<fullUrl
value="http://fhir.ch-idmp.smc.admin.ch/PackagedProductDefinition/PMP-Enfortumabum-vedotinum-20-Powder"/>
<resource>
<PackagedProductDefinition>
<id value="PMP-Enfortumabum-vedotinum-20-Powder"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-packagedproductdefinition"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_PMP-Enfortumabum-vedotinum-20-Powder"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition PMP-Enfortumabum-vedotinum-20-Powder</b></p><a name="PMP-Enfortumabum-vedotinum-20-Powder"> </a><a name="hcPMP-Enfortumabum-vedotinum-20-Powder"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ch-idmp-packagedproductdefinition.html">PackagedProductDefinition</a></p></div><p><b>identifier</b>: <a href="NamingSystem-PCID.html" title="Temporary Identifier in this implementation guide until officially released by Swissmedic">Clinical Product Identifier</a>/CH-01100869-0682910030000-0001</p><p><b>packageFor</b>: <a href="MedicinalProductDefinition-Padcev-20mg-Powder.html">MedicinalProductDefinition: extension = Lyophilisate for solution for infusion; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#Medical Product Identifier#CH-01100869-0682910030000; indication = Padcev ist indiziert zur Behandlung von Erwachsenen mit lokal fortgeschrittenem oder metastasiertem Urothelkarzinom (mUC), die eine platinhaltige Chemotherapie im neoadjuvanten/adjuvanten, lokal fortgeschrittenen oder metastasierten Setting erhalten haben und die während oder nach der Behandlung mit einem Inhibitor des programmierten Zelltodrezeptors-1 (PD-1) oder des programmierten Zelltod-Liganden 1 (PD-L1) einen Progress oder einen Rückfall der Erkrankung erlitten haben.; legalStatusOfSupply = A: Single dispensing requiring a medical or veterinary prescription; additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Not authorised for the treatment in children; classification = gilteritinib,NA KAS art. 12 para. 5 TPLO,Biologics</a></p><p><b>containedItemQuantity</b>: 20 mg<span style="background: LightGoldenRodYellow"> (Details: UCUM codemg = 'mg')</span></p><p><b>description</b>: </p><div><p>Durchstechflasche 1 Stk</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-idmp/CodeSystem/ch-SMC-legal-status-of-supply 756005034000001}">A: Single dispensing requiring a medical or veterinary prescription</span></td></tr></table><h3>MarketingStatuses</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Country</b></td><td><b>Status</b></td><td><b>DateRange</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:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-Refdata-marketing-status 756002026002}">Marketed</span></td><td>2011-09-11 --> (ongoing)</td></tr></table><blockquote><p><b>packaging</b></p><p><b>identifier</b>: <a href="http://terminology.hl7.org/7.1.0/NamingSystem-gtin.html" title="The GS1 GTIN is a globally unique identifier of trade items. A trade item is any item (product or service) upon which there is a need to retrieve pre-defined information and that may be priced, or ordered, or invoiced at any point in any supply chain. Note: GTINs may be used in both Codes (http://build.fhir.org/datatypes.html#Coding) and Identifiers (http://build.fhir.org/datatypes.html#Identifier).">GTIN Global Trade Item Number</a>/7680682910021</p><p><b>type</b>: <span title="Codes:{http://standardterms.edqm.eu 30009000}">Box</span></p><p><b>quantity</b>: 6</p><h3>ShelfLifeStorages</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Period[x]</b></td><td><b>SpecialPrecautionsForStorage</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://spor.ema.europa.eu/v1/lists/100000073343 100000073405}">Shelf life after dilution or reconstitution according to directions</span></td><td>No display for Duration (value: 16; unit: hour; system: http://unitsofmeasure.org; code: h)</td><td><span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-special-precautions-for-storage 756005041000011}">Store in the original container</span></td></tr></table><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title="Codes:{http://standardterms.edqm.eu 30069000}">Vial</span></p><p><b>quantity</b>: 1</p><blockquote><p><b>containedItem</b></p><h3>Items</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="ManufacturedItemDefinition-MI-Enfortumabum-vedotinum-30-Powder.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Lyophilisate for solution for infusion; unitOfPresentation = Vial</a></td></tr></table><p><b>amount</b>: 20 mg<span style="background: LightGoldenRodYellow"> (Details: UCUM codemg = 'mg')</span></p></blockquote></blockquote></blockquote></div>
</text>
<identifier>
<system value="http://fhir.ch/ig/ch-idmp/sid/pcid"/>
<value value="CH-01100869-0682910030000-0001"/>
</identifier>
<packageFor>🔗
<reference value="MedicinalProductDefinition/Padcev-20mg-Powder"/>
</packageFor>
<containedItemQuantity>
<value value="20"/>
<unit value="mg"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg"/>
</containedItemQuantity>
<description value="Durchstechflasche 1 Stk"/>
<legalStatusOfSupply>
<code>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-legal-status-of-supply"/>
<code value="756005034000001"/>
<display
value="A: Single dispensing requiring a medical or veterinary prescription"/>
</coding>
</code>
</legalStatusOfSupply>
<marketingStatus>
<country>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="CH"/>
<display value="Switzerland"/>
</coding>
</country>
<status>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-Refdata-marketing-status"/>
<code value="756002026002"/>
<display value="Marketed"/>
</coding>
</status>
<dateRange>
<start value="2011-09-11"/>
</dateRange>
</marketingStatus>
<packaging>
<identifier>
<system value="https://www.gs1.org/gtin"/>
<value value="7680682910021"/>
</identifier>
<type>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="30009000"/>
<display value="Box"/>
</coding>
</type>
<quantity value="6"/>
<shelfLifeStorage>
<type>
<coding>
<system
value="http://spor.ema.europa.eu/v1/lists/100000073343"/>
<code value="100000073405"/>
<display
value="Shelf life after dilution or reconstitution according to directions"/>
</coding>
</type>
<periodDuration>
<value value="16"/>
<unit value="hour"/>
<system value="http://unitsofmeasure.org"/>
<code value="h"/>
</periodDuration>
<specialPrecautionsForStorage>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-special-precautions-for-storage"/>
<code value="756005041000011"/>
<display value="Store in the original container"/>
</coding>
</specialPrecautionsForStorage>
</shelfLifeStorage>
<packaging>
<type>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="30069000"/>
<display value="Vial"/>
</coding>
</type>
<quantity value="1"/>
<containedItem>
<item>
<reference>🔗
<reference
value="ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-30-Powder"/>
</reference>
</item>
<amount>
<value value="20"/>
<unit value="mg"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg"/>
</amount>
</containedItem>
</packaging>
</packaging>
</PackagedProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://fhir.ch-idmp.smc.admin.ch/RegulatedAuthorisation/MA-68291001"/>
<resource>
<RegulatedAuthorization>
<id value="MA-68291001"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-regulatedauthorization"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_MA-68291001"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization MA-68291001</b></p><a name="MA-68291001"> </a><a name="hcMA-68291001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ch-idmp-regulatedauthorization.html">RegulatedAuthorization</a></p></div><p><b>identifier</b>: <a href="NamingSystem-AuthNo.html" title="Temporary Identifier in this implementation guide until officially released by Swissmedic">Marketing Authorisation Number</a>/68291001</p><p><b>subject</b>: <a href="PackagedProductDefinition-PMP-Enfortumabum-vedotinum-20-Powder.html">PackagedProductDefinition: identifier = http://fhir.ch/ig/ch-idmp/sid/pcid#Clinical Product Identifier#CH-01100869-0682910030000-0001; containedItemQuantity = 20 mg; description = Durchstechflasche 1 Stk</a></p><p><b>type</b>: <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-authorisation-type-cs 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-idmp/CodeSystem/ch-SMC-authorisation-status 756005010000001}">approved</span></p><p><b>statusDate</b>: 2021-11-09</p><p><b>validityPeriod</b>: 2021-11-09 --> 2026-11-08</p><p><b>holder</b>: <a href="#hcMA-68291001/holder-Astellas-Pharma-AG">Organization Astellas Pharma AG</a></p><p><b>regulator</b>: <a href="#hcMA-68291001/regulator-SMC">Organization SMC</a></p><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Organization #holder-Astellas-Pharma-AG</b></p><a name="MA-68291001/holder-Astellas-Pharma-AG"> </a><a name="hcMA-68291001/holder-Astellas-Pharma-AG"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ch-idmp-organization.html">Organization</a></p></div><p><b>identifier</b>: <a href="NamingSystem-SMCLocID.html" title="Temporary NamingSystem in this implementation guide until officially released by Swissmedic">Swissmedic Location Identifier</a>/01100869, <a href="NamingSystem-LOC.html" title="Identifier holding a number for LocID (Location Identifier of the European Medicines Agency - Organisation Management System OMS)">LOC Identifier</a>/100010745, <a href="NamingSystem-GLN.html" title="Identifier holding a number for GLN (Global Location Number)">GLN Identifier</a>/7601001000964</p><p><b>name</b>: Astellas Pharma AG</p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Organization #regulator-SMC</b></p><a name="MA-68291001/regulator-SMC"> </a><a name="hcMA-68291001/regulator-SMC"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ch-idmp-organization.html">Organization</a></p></div><p><b>identifier</b>: <a href="NamingSystem-LOC.html" title="Identifier holding a number for LocID (Location Identifier of the European Medicines Agency - Organisation Management System OMS)">LOC Identifier</a>/100010911, <a href="NamingSystem-GLN.html" title="Identifier holding a number for GLN (Global Location Number)">GLN Identifier</a>/7601001398511</p><p><b>name</b>: SMC</p></blockquote></div>
</text>
<contained>
<Organization>
<id value="holder-Astellas-Pharma-AG"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization"/>
</meta>
<identifier>
<system
value="https://www.swissmedic.ch/fhir/identifier/locations"/>
<value value="01100869"/>
</identifier>
<identifier>
<system value="https://spor.ema.europa.eu/v1/locations"/>
<value value="100010745"/>
</identifier>
<identifier>
<system value="urn:oid:2.51.1.3"/>
<value value="7601001000964"/>
</identifier>
<name value="Astellas Pharma AG"/>
</Organization>
</contained>
<contained>
<Organization>
<id value="regulator-SMC"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization"/>
</meta>
<identifier>
<system value="https://spor.ema.europa.eu/v1/locations"/>
<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://fhir.ch/ig/ch-idmp/sid/authno"/>
<value value="68291001"/>
</identifier>
<subject>🔗
<reference
value="PackagedProductDefinition/PMP-Enfortumabum-vedotinum-20-Powder"/>
</subject>
<type>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-authorisation-type-cs"/>
<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-idmp/CodeSystem/ch-SMC-authorisation-status"/>
<code value="756005010000001"/>
<display value="approved"/>
</coding>
</status>
<statusDate value="2021-11-09"/>
<validityPeriod>
<start value="2021-11-09"/>
<end value="2026-11-08"/>
</validityPeriod>
<holder>
<reference value="#holder-Astellas-Pharma-AG"/>
</holder>
<regulator>
<reference value="#regulator-SMC"/>
</regulator>
</RegulatedAuthorization>
</resource>
</entry>
<entry>
<fullUrl
value="http://fhir.ch-idmp.smc.admin.ch/ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-20-Powder"/>
<resource>
<ManufacturedItemDefinition>
<id value="MI-Enfortumabum-vedotinum-20-Powder"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-manufactureditemdefinition"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ManufacturedItemDefinition_MI-Enfortumabum-vedotinum-20-Powder"> </a><p class="res-header-id"><b>Generated Narrative: ManufacturedItemDefinition MI-Enfortumabum-vedotinum-20-Powder</b></p><a name="MI-Enfortumabum-vedotinum-20-Powder"> </a><a name="hcMI-Enfortumabum-vedotinum-20-Powder"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ch-idmp-manufactureditemdefinition.html">ManufacturedItemDefinition</a></p></div><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title="Codes:{http://standardterms.edqm.eu 11215000}">Lyophilisate for solution for infusion</span></p><p><b>unitOfPresentation</b>: <span title="Codes:{http://standardterms.edqm.eu 15060000}">Vial</span></p></div>
</text>
<status value="active"/>
<manufacturedDoseForm>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="11215000"/>
<display value="Lyophilisate for solution for infusion"/>
</coding>
</manufacturedDoseForm>
<unitOfPresentation>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="15060000"/>
<display value="Vial"/>
</coding>
</unitOfPresentation>
</ManufacturedItemDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://fhir.ch-idmp.smc.admin.ch/AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution"/>
<resource>
<AdministrableProductDefinition>
<id value="PhP-Enfortumabum-vedotinum-20-Solution"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-administrableproductdefinition"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="AdministrableProductDefinition_PhP-Enfortumabum-vedotinum-20-Solution"> </a><p class="res-header-id"><b>Generated Narrative: AdministrableProductDefinition PhP-Enfortumabum-vedotinum-20-Solution</b></p><a name="PhP-Enfortumabum-vedotinum-20-Solution"> </a><a name="hcPhP-Enfortumabum-vedotinum-20-Solution"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ch-idmp-administrableproductdefinition.html">AdministrableProductDefinition</a></p></div><p><b>status</b>: Active</p><p><b>formOf</b>: <a href="MedicinalProductDefinition-Padcev-20mg-Powder.html">MedicinalProductDefinition: extension = Lyophilisate for solution for infusion; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#Medical Product Identifier#CH-01100869-0682910030000; indication = Padcev ist indiziert zur Behandlung von Erwachsenen mit lokal fortgeschrittenem oder metastasiertem Urothelkarzinom (mUC), die eine platinhaltige Chemotherapie im neoadjuvanten/adjuvanten, lokal fortgeschrittenen oder metastasierten Setting erhalten haben und die während oder nach der Behandlung mit einem Inhibitor des programmierten Zelltodrezeptors-1 (PD-1) oder des programmierten Zelltod-Liganden 1 (PD-L1) einen Progress oder einen Rückfall der Erkrankung erlitten haben.; legalStatusOfSupply = A: Single dispensing requiring a medical or veterinary prescription; additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Not authorised for the treatment in children; classification = gilteritinib,NA KAS art. 12 para. 5 TPLO,Biologics</a></p><p><b>administrableDoseForm</b>: <span title="Codes:{http://standardterms.edqm.eu 11210000}">Solution for Infusion</span></p><p><b>unitOfPresentation</b>: <span title="Codes:{http://standardterms.edqm.eu 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:{http://standardterms.edqm.eu 20045000}">Intravenous use</span></td></tr></table></div>
</text>
<status value="active"/>
<formOf>🔗
<reference value="MedicinalProductDefinition/Padcev-20mg-Powder"/>
</formOf>
<administrableDoseForm>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="11210000"/>
<display value="Solution for Infusion"/>
</coding>
</administrableDoseForm>
<unitOfPresentation>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="15060000"/>
<display value="Vial"/>
</coding>
</unitOfPresentation>
<routeOfAdministration>
<code>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="20045000"/>
<display value="Intravenous use"/>
</coding>
</code>
</routeOfAdministration>
</AdministrableProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://fhir.ch-idmp.smc.admin.ch/Ingredient/EnfortumabumVedotinum20"/>
<resource>
<Ingredient>
<id value="EnfortumabumVedotinum20"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_EnfortumabumVedotinum20"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient EnfortumabumVedotinum20</b></p><a name="EnfortumabumVedotinum20"> </a><a name="hcEnfortumabumVedotinum20"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ch-idmp-ingredient.html">Ingredient</a></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="AdministrableProductDefinition-PhP-Enfortumabum-vedotinum-20-Solution.html">AdministrableProductDefinition: status = active; administrableDoseForm = Solution for Infusion; unitOfPresentation = Vial</a></li><li><a href="ManufacturedItemDefinition-MI-Enfortumabum-vedotinum-20-Powder.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Lyophilisate for solution for infusion; unitOfPresentation = Vial</a></li></ul><p><b>role</b>: <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role 756005035000001}">Active</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-idmp/CodeSystem/ch-SMC-substance DLE8519RWM}">Enfortumab vedotin</span></td></tr></table><blockquote><p><b>strength</b></p><p><b>presentation</b>: 20 mg<span style="background: LightGoldenRodYellow"> (Details: UCUM codemg = 'mg')</span>/1 vial<span style="background: LightGoldenRodYellow"> (Details: EDQM - Standard Terms code15060000 = 'Vial')</span></p><blockquote><p><b>referenceStrength</b></p><h3>Substances</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-idmp/CodeSystem/ch-SMC-substance DLE8519RWM}">Enfortumab vedotin</span></td></tr></table><p><b>strength</b>: 20 mg<span style="background: LightGoldenRodYellow"> (Details: UCUM codemg = 'mg')</span>/1 vial<span style="background: LightGoldenRodYellow"> (Details: EDQM - Standard Terms code15060000 = 'Vial')</span></p></blockquote></blockquote></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference
value="AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution"/>
</for>
<for>🔗
<reference
value="ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-20-Powder"/>
</for>
<role>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role"/>
<code value="756005035000001"/>
<display value="Active"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance"/>
<code value="DLE8519RWM"/>
<display value="Enfortumab vedotin"/>
</coding>
</concept>
</code>
<strength>
<presentationRatio>
<numerator>
<value value="20"/>
<unit value="mg"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="vial"/>
<system value="http://standardterms.edqm.eu"/>
<code value="15060000"/>
</denominator>
</presentationRatio>
<referenceStrength>
<substance>
<concept>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance"/>
<code value="DLE8519RWM"/>
<display value="Enfortumab vedotin"/>
</coding>
</concept>
</substance>
<strengthRatio>
<numerator>
<value value="20"/>
<unit value="mg"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="vial"/>
<system value="http://standardterms.edqm.eu"/>
<code value="15060000"/>
</denominator>
</strengthRatio>
</referenceStrength>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="http://fhir.ch-idmp.smc.admin.ch/Ingredient/Histidinum"/>
<resource>
<Ingredient>
<id value="Histidinum"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_Histidinum"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient Histidinum</b></p><a name="Histidinum"> </a><a name="hcHistidinum"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ch-idmp-ingredient.html">Ingredient</a></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="AdministrableProductDefinition-PhP-Enfortumabum-vedotinum-20-Solution.html">AdministrableProductDefinition: status = active; administrableDoseForm = Solution for Infusion; unitOfPresentation = Vial</a></li><li><a href="ManufacturedItemDefinition-MI-Enfortumabum-vedotinum-20-Powder.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Lyophilisate for solution for infusion; unitOfPresentation = Vial</a></li><li><a href="AdministrableProductDefinition-PhP-Enfortumabum-vedotinum-30-Solution.html">AdministrableProductDefinition: status = active; administrableDoseForm = Solution for Infusion; unitOfPresentation = Vial</a></li><li><a href="ManufacturedItemDefinition-MI-Enfortumabum-vedotinum-30-Powder.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Lyophilisate for solution for infusion; unitOfPresentation = Vial</a></li></ul><p><b>role</b>: <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role 756005035000002}">Excipient</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-idmp/CodeSystem/ch-SMC-substance 4QD397987E}">Histidine</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference
value="AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution"/>
</for>
<for>🔗
<reference
value="ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-20-Powder"/>
</for>
<for>🔗
<reference
value="AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-30-Solution"/>
</for>
<for>🔗
<reference
value="ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-30-Powder"/>
</for>
<role>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role"/>
<code value="756005035000002"/>
<display value="Excipient"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance"/>
<code value="4QD397987E"/>
<display value="Histidine"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://fhir.ch-idmp.smc.admin.ch/Ingredient/HistidiniHydrochloridumMonohydricum"/>
<resource>
<Ingredient>
<id value="HistidiniHydrochloridumMonohydricum"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_HistidiniHydrochloridumMonohydricum"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient HistidiniHydrochloridumMonohydricum</b></p><a name="HistidiniHydrochloridumMonohydricum"> </a><a name="hcHistidiniHydrochloridumMonohydricum"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ch-idmp-ingredient.html">Ingredient</a></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="AdministrableProductDefinition-PhP-Enfortumabum-vedotinum-20-Solution.html">AdministrableProductDefinition: status = active; administrableDoseForm = Solution for Infusion; unitOfPresentation = Vial</a></li><li><a href="ManufacturedItemDefinition-MI-Enfortumabum-vedotinum-20-Powder.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Lyophilisate for solution for infusion; unitOfPresentation = Vial</a></li><li><a href="AdministrableProductDefinition-PhP-Enfortumabum-vedotinum-30-Solution.html">AdministrableProductDefinition: status = active; administrableDoseForm = Solution for Infusion; unitOfPresentation = Vial</a></li><li><a href="ManufacturedItemDefinition-MI-Enfortumabum-vedotinum-30-Powder.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Lyophilisate for solution for infusion; unitOfPresentation = Vial</a></li></ul><p><b>role</b>: <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role 756005035000002}">Excipient</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-idmp/CodeSystem/ch-SMC-substance X573657P6P}">Histidine hydrochloride monohydrate</span></td></tr></table></blockquote></div>
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<status value="active"/>
<for>🔗
<reference
value="AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution"/>
</for>
<for>🔗
<reference
value="ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-20-Powder"/>
</for>
<for>🔗
<reference
value="AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-30-Solution"/>
</for>
<for>🔗
<reference
value="ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-30-Powder"/>
</for>
<role>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role"/>
<code value="756005035000002"/>
<display value="Excipient"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance"/>
<code value="X573657P6P"/>
<display value="Histidine hydrochloride monohydrate"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://fhir.ch-idmp.smc.admin.ch/Ingredient/TrehalosumDihydricum"/>
<resource>
<Ingredient>
<id value="TrehalosumDihydricum"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_TrehalosumDihydricum"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient TrehalosumDihydricum</b></p><a name="TrehalosumDihydricum"> </a><a name="hcTrehalosumDihydricum"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ch-idmp-ingredient.html">Ingredient</a></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="AdministrableProductDefinition-PhP-Enfortumabum-vedotinum-20-Solution.html">AdministrableProductDefinition: status = active; administrableDoseForm = Solution for Infusion; unitOfPresentation = Vial</a></li><li><a href="ManufacturedItemDefinition-MI-Enfortumabum-vedotinum-20-Powder.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Lyophilisate for solution for infusion; unitOfPresentation = Vial</a></li><li><a href="AdministrableProductDefinition-PhP-Enfortumabum-vedotinum-30-Solution.html">AdministrableProductDefinition: status = active; administrableDoseForm = Solution for Infusion; unitOfPresentation = Vial</a></li><li><a href="ManufacturedItemDefinition-MI-Enfortumabum-vedotinum-30-Powder.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Lyophilisate for solution for infusion; unitOfPresentation = Vial</a></li></ul><p><b>role</b>: <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role 756005035000002}">Excipient</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-idmp/CodeSystem/ch-SMC-substance 7YIN7J07X4}">Trehalose dihydrate</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference
value="AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution"/>
</for>
<for>🔗
<reference
value="ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-20-Powder"/>
</for>
<for>🔗
<reference
value="AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-30-Solution"/>
</for>
<for>🔗
<reference
value="ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-30-Powder"/>
</for>
<role>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role"/>
<code value="756005035000002"/>
<display value="Excipient"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance"/>
<code value="7YIN7J07X4"/>
<display value="Trehalose dihydrate"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://fhir.ch-idmp.smc.admin.ch/Ingredient/Polysorbatum20"/>
<resource>
<Ingredient>
<id value="Polysorbatum20"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_Polysorbatum20"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient Polysorbatum20</b></p><a name="Polysorbatum20"> </a><a name="hcPolysorbatum20"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ch-idmp-ingredient.html">Ingredient</a></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="AdministrableProductDefinition-PhP-Enfortumabum-vedotinum-20-Solution.html">AdministrableProductDefinition: status = active; administrableDoseForm = Solution for Infusion; unitOfPresentation = Vial</a></li><li><a href="ManufacturedItemDefinition-MI-Enfortumabum-vedotinum-20-Powder.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Lyophilisate for solution for infusion; unitOfPresentation = Vial</a></li><li><a href="AdministrableProductDefinition-PhP-Enfortumabum-vedotinum-30-Solution.html">AdministrableProductDefinition: status = active; administrableDoseForm = Solution for Infusion; unitOfPresentation = Vial</a></li><li><a href="ManufacturedItemDefinition-MI-Enfortumabum-vedotinum-30-Powder.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Lyophilisate for solution for infusion; unitOfPresentation = Vial</a></li></ul><p><b>role</b>: <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role 756005035000002}">Excipient</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-idmp/CodeSystem/ch-SMC-substance 7T1F30V5YH}">Polysorbate 20</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference
value="AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution"/>
</for>
<for>🔗
<reference
value="ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-20-Powder"/>
</for>
<for>🔗
<reference
value="AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-30-Solution"/>
</for>
<for>🔗
<reference
value="ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-30-Powder"/>
</for>
<role>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role"/>
<code value="756005035000002"/>
<display value="Excipient"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance"/>
<code value="7T1F30V5YH"/>
<display value="Polysorbate 20"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://fhir.ch-idmp.smc.admin.ch/Ingredient/AquaAdIniectabile"/>
<resource>
<Ingredient>
<id value="AquaAdIniectabile"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_AquaAdIniectabile"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient AquaAdIniectabile</b></p><a name="AquaAdIniectabile"> </a><a name="hcAquaAdIniectabile"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ch-idmp-ingredient.html">Ingredient</a></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="AdministrableProductDefinition-PhP-Enfortumabum-vedotinum-20-Solution.html">AdministrableProductDefinition: status = active; administrableDoseForm = Solution for Infusion; unitOfPresentation = Vial</a></li><li><a href="AdministrableProductDefinition-PhP-Enfortumabum-vedotinum-30-Solution.html">AdministrableProductDefinition: status = active; administrableDoseForm = Solution for Infusion; unitOfPresentation = Vial</a></li></ul><p><b>role</b>: <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role 756005035000002}">Excipient</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-idmp/CodeSystem/ch-SMC-substance 059QF0KO0R}">Water</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference
value="AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution"/>
</for>
<for>🔗
<reference
value="AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-30-Solution"/>
</for>
<role>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role"/>
<code value="756005035000002"/>
<display value="Excipient"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance"/>
<code value="059QF0KO0R"/>
<display value="Water"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10057352"/>
<resource>
<ClinicalUseDefinition>
<id value="IND-10057352"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ClinicalUseDefinition_IND-10057352"> </a><p class="res-header-id"><b>Generated Narrative: ClinicalUseDefinition IND-10057352</b></p><a name="IND-10057352"> </a><a name="hcIND-10057352"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ch-idmp-clinicalusedefinition-indication.html">ClinicalUseDefinition Indication</a></p></div><p><b>type</b>: Indication</p><p><b>subject</b>: <a href="MedicinalProductDefinition-Padcev-20mg-Powder.html">MedicinalProductDefinition: extension = Lyophilisate for solution for infusion; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#Medical Product Identifier#CH-01100869-0682910030000; indication = Padcev ist indiziert zur Behandlung von Erwachsenen mit lokal fortgeschrittenem oder metastasiertem Urothelkarzinom (mUC), die eine platinhaltige Chemotherapie im neoadjuvanten/adjuvanten, lokal fortgeschrittenen oder metastasierten Setting erhalten haben und die während oder nach der Behandlung mit einem Inhibitor des programmierten Zelltodrezeptors-1 (PD-1) oder des programmierten Zelltod-Liganden 1 (PD-L1) einen Progress oder einen Rückfall der Erkrankung erlitten haben.; legalStatusOfSupply = A: Single dispensing requiring a medical or veterinary prescription; additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Not authorised for the treatment in children; classification = gilteritinib,NA KAS art. 12 para. 5 TPLO,Biologics</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 10057352}">Metastatic carcinoma of the bladder</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:{http://spor.ema.europa.eu/v1/lists/200000003186 756005042000002}">therapeutic</span></td></tr></table></blockquote></div>
</text>
<type value="indication"/>
<subject>🔗
<reference value="MedicinalProductDefinition/Padcev-20mg-Powder"/>
</subject>
<indication>
<diseaseSymptomProcedure>
<concept>
<coding>
<system value="https://www.meddra.org"/>
<code value="10057352"/>
<display value="Metastatic carcinoma of the bladder"/>
</coding>
</concept>
</diseaseSymptomProcedure>
<intendedEffect>
<concept>
<coding>
<system
value="http://spor.ema.europa.eu/v1/lists/200000003186"/>
<code value="756005042000002"/>
<display value="therapeutic"/>
</coding>
</concept>
</intendedEffect>
</indication>
</ClinicalUseDefinition>
</resource>
</entry>
</Bundle>