CH IDMP (R5)
1.0.0-ballot - ballot Switzerland flag

This page is part of the CH IDMP (v1.0.0-ballot: DSTU 1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions

: Padcev 20 mg, Pulver für ein Konzentrat zur Herstellung einer Infusionslösung (Bundle) - TTL Representation

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

 a fhir:Bundle ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "a058182b-13dc-4797-9364-2cdb9a4c2bd4"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-bundle"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-bundle>     ] )
  ] ; # 
  fhir:language [ fhir:v "de-CH"] ; # 
  fhir:type [ fhir:v "collection"] ; # 
  fhir:entry ( [
fhir:fullUrl [
fhir:v "http://fhir.ch-idmp.smc.admin.ch/MedicinalProductDefinition/Padcev-20mg-Powder"^^xsd:anyURI ;
fhir:l <http://fhir.ch-idmp.smc.admin.ch/MedicinalProductDefinition/Padcev-20mg-Powder>     ] ;
    ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/MedicinalProductDefinition/Padcev-20mg-Powder> )
  ] [
fhir:fullUrl [
fhir:v "http://fhir.ch-idmp.smc.admin.ch/DocumentReference/DocRef-FI-Padcev"^^xsd:anyURI ;
fhir:l <http://fhir.ch-idmp.smc.admin.ch/DocumentReference/DocRef-FI-Padcev>     ] ;
    ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/DocumentReference/DocRef-FI-Padcev> )
  ] [
fhir:fullUrl [
fhir:v "http://fhir.ch-idmp.smc.admin.ch/RegulatedAuthorisation/MA-6829103"^^xsd:anyURI ;
fhir:l <http://fhir.ch-idmp.smc.admin.ch/RegulatedAuthorisation/MA-6829103>     ] ;
    ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/RegulatedAuthorisation/MA-6829103> )
  ] [
fhir:fullUrl [
fhir:v "http://fhir.ch-idmp.smc.admin.ch/PackagedProductDefinition/PMP-Enfortumabum-vedotinum-20-Powder"^^xsd:anyURI ;
fhir:l <http://fhir.ch-idmp.smc.admin.ch/PackagedProductDefinition/PMP-Enfortumabum-vedotinum-20-Powder>     ] ;
    ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/PackagedProductDefinition/PMP-Enfortumabum-vedotinum-20-Powder> )
  ] [
fhir:fullUrl [
fhir:v "http://fhir.ch-idmp.smc.admin.ch/RegulatedAuthorisation/MA-68291001"^^xsd:anyURI ;
fhir:l <http://fhir.ch-idmp.smc.admin.ch/RegulatedAuthorisation/MA-68291001>     ] ;
    ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/RegulatedAuthorisation/MA-68291001> )
  ] [
fhir:fullUrl [
fhir:v "http://fhir.ch-idmp.smc.admin.ch/ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-20-Powder"^^xsd:anyURI ;
fhir:l <http://fhir.ch-idmp.smc.admin.ch/ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-20-Powder>     ] ;
    ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-20-Powder> )
  ] [
fhir:fullUrl [
fhir:v "http://fhir.ch-idmp.smc.admin.ch/AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution"^^xsd:anyURI ;
fhir:l <http://fhir.ch-idmp.smc.admin.ch/AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution>     ] ;
    ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution> )
  ] [
fhir:fullUrl [
fhir:v "http://fhir.ch-idmp.smc.admin.ch/Ingredient/EnfortumabumVedotinum20"^^xsd:anyURI ;
fhir:l <http://fhir.ch-idmp.smc.admin.ch/Ingredient/EnfortumabumVedotinum20>     ] ;
    ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/Ingredient/EnfortumabumVedotinum20> )
  ] [
fhir:fullUrl [
fhir:v "http://fhir.ch-idmp.smc.admin.ch/Ingredient/Histidinum"^^xsd:anyURI ;
fhir:l <http://fhir.ch-idmp.smc.admin.ch/Ingredient/Histidinum>     ] ;
    ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/Ingredient/Histidinum> )
  ] [
fhir:fullUrl [
fhir:v "http://fhir.ch-idmp.smc.admin.ch/Ingredient/HistidiniHydrochloridumMonohydricum"^^xsd:anyURI ;
fhir:l <http://fhir.ch-idmp.smc.admin.ch/Ingredient/HistidiniHydrochloridumMonohydricum>     ] ;
    ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/Ingredient/HistidiniHydrochloridumMonohydricum> )
  ] [
fhir:fullUrl [
fhir:v "http://fhir.ch-idmp.smc.admin.ch/Ingredient/TrehalosumDihydricum"^^xsd:anyURI ;
fhir:l <http://fhir.ch-idmp.smc.admin.ch/Ingredient/TrehalosumDihydricum>     ] ;
    ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/Ingredient/TrehalosumDihydricum> )
  ] [
fhir:fullUrl [
fhir:v "http://fhir.ch-idmp.smc.admin.ch/Ingredient/Polysorbatum20"^^xsd:anyURI ;
fhir:l <http://fhir.ch-idmp.smc.admin.ch/Ingredient/Polysorbatum20>     ] ;
    ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/Ingredient/Polysorbatum20> )
  ] [
fhir:fullUrl [
fhir:v "http://fhir.ch-idmp.smc.admin.ch/Ingredient/AquaAdIniectabile"^^xsd:anyURI ;
fhir:l <http://fhir.ch-idmp.smc.admin.ch/Ingredient/AquaAdIniectabile>     ] ;
    ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/Ingredient/AquaAdIniectabile> )
  ] [
fhir:fullUrl [
fhir:v "http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10057352"^^xsd:anyURI ;
fhir:l <http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10057352>     ] ;
    ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10057352> )
  ] ) . # 

<http://fhir.ch-idmp.smc.admin.ch/MedicinalProductDefinition/Padcev-20mg-Powder> a fhir:MedicinalProductDefinition ;
  fhir:id [ fhir:v "Padcev-20mg-Powder"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-medicinalproductdefinition"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-medicinalproductdefinition>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "extensions" ] ;
fhir:div [ fhir:v "<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>\n</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 --&gt; (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>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:extension ( [
fhir:url [
fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/authorizedDoseForm"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/authorizedDoseForm>     ] ;
fhir:value [
a fhir:CodeableConcept ;
      ( fhir:coding [
fhir:system [
fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ;
fhir:l <http://standardterms.edqm.eu>         ] ;
fhir:code [ fhir:v "11215000" ] ;
fhir:display [ fhir:v "Lyophilisate for solution for infusion" ]       ] )     ]
  ] ) ; # 
  fhir:identifier ( [
fhir:system [
fhir:v "http://fhir.ch/ig/ch-idmp/sid/mpid"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/sid/mpid>     ] ;
fhir:value [ fhir:v "CH-01100869-0682910030000" ]
  ] ) ; # 
  fhir:indication [ fhir:v "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."] ; # 
  fhir:legalStatusOfSupply [
    ( fhir:coding [
fhir:system [
fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-legal-status-of-supply"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-legal-status-of-supply>       ] ;
fhir:code [ fhir:v "756005034000001" ] ;
fhir:display [ fhir:v "A: Single dispensing requiring a medical or veterinary prescription" ]     ] )
  ] ; # 
  fhir:additionalMonitoringIndicator [
    ( fhir:coding [
fhir:system [
fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-additional-monitoring-indicator"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-additional-monitoring-indicator>       ] ;
fhir:code [ fhir:v "756005001003" ] ;
fhir:display [ fhir:v "No Warning" ]     ] )
  ] ; # 
  fhir:pediatricUseIndicator [
    ( fhir:coding [
fhir:system [
fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-pediatric-use-indicator"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-pediatric-use-indicator>       ] ;
fhir:code [ fhir:v "756005003002" ] ;
fhir:display [ fhir:v "Not authorised for the treatment in children" ]     ] )
  ] ; # 
  fhir:classification ( [
    ( fhir:coding [
fhir:system [
fhir:v "http://www.whocc.no/atc"^^xsd:anyURI ;
fhir:l <http://www.whocc.no/atc>       ] ;
fhir:code [ fhir:v "L01EX13" ]     ] )
  ] [
    ( fhir:coding [
fhir:system [
fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-authorisation-category"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-authorisation-category>       ] ;
fhir:code [ fhir:v "756005011000005" ] ;
fhir:display [ fhir:v "NA KAS art. 12 para. 5 TPLO" ]     ] )
  ] [
    ( fhir:coding [
fhir:system [
fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-MedicinalProductCategory"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-MedicinalProductCategory>       ] ;
fhir:code [ fhir:v "756005039000003" ] ;
fhir:display [ fhir:v "Biologics" ]     ] )
  ] ) ; # 
  fhir:marketingStatus ( [
fhir:country [
      ( fhir:coding [
fhir:system [
fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ;
fhir:l <urn:iso:std:iso:3166>         ] ;
fhir:code [ fhir:v "CH" ] ;
fhir:display [ fhir:v "Switzerland" ]       ] )     ] ;
fhir:status [
      ( fhir:coding [
fhir:system [
fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-marketing-status"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-marketing-status>         ] ;
fhir:code [ fhir:v "7560050074000003" ] ;
fhir:display [ fhir:v "No interruption of distribution reported" ]       ] )     ] ;
fhir:dateRange [
fhir:start [ fhir:v "2011-09-11"^^xsd:date ]     ]
  ] ) ; # 
  fhir:attachedDocument ( [
fhir:l fhir:DocumentReference/DocRef-FI-Padcev ;
fhir:reference [ fhir:v "DocumentReference/DocRef-FI-Padcev" ]
  ] ) ; # 
  fhir:name ( [
fhir:productName [ fhir:v "Padcev 20 mg, Pulver für ein Konzentrat zur Herstellung einer Infusionslösung" ] ;
    ( fhir:usage [
fhir:country [
        ( fhir:coding [
fhir:system [
fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ;
fhir:l <urn:iso:std:iso:3166>           ] ;
fhir:code [ fhir:v "CH" ] ;
fhir:display [ fhir:v "Switzerland" ]         ] )       ] ;
fhir:language [
        ( fhir:coding [
fhir:system [
fhir:v "urn:ietf:bcp:47"^^xsd:anyURI ;
fhir:l <urn:ietf:bcp:47>           ] ;
fhir:code [ fhir:v "de-CH" ]         ] )       ]     ] )
  ] ) . # 

<http://fhir.ch-idmp.smc.admin.ch/DocumentReference/DocRef-FI-Padcev> a fhir:DocumentReference ;
  fhir:id [ fhir:v "DocRef-FI-Padcev"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-documentreference"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-documentreference>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div [ fhir:v "<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&amp;lang=DE&amp;authNr=68291&amp;supportMultipleResults=1\">https://Swissmedicinfo.ch/showText.aspx?textType=FI&amp;lang=DE&amp;authNr=68291&amp;supportMultipleResults=1</a></td></tr></table></blockquote></div>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:identifier ( [
fhir:system [
fhir:v "http://fhir.ch/ig/ch-idmp/sid/attno"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/sid/attno>     ] ;
fhir:value [ fhir:v "123456989-initial submission-Example-xyz-321" ]
  ] ) ; # 
  fhir:status [ fhir:v "current"] ; # 
  fhir:type [
    ( fhir:coding [
fhir:system [
fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-attached-document-type"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-attached-document-type>       ] ;
fhir:code [ fhir:v "756005040000001" ] ;
fhir:display [ fhir:v "Information for healthcare professionals" ]     ] )
  ] ; # 
  fhir:date [ fhir:v "2021-11-09T00:00:00Z"^^xsd:dateTime] ; # 
  fhir:content ( [
fhir:attachment [
fhir:language [ fhir:v "de-CH" ] ;
fhir:url [
fhir:v "https://Swissmedicinfo.ch/showText.aspx?textType=FI&lang=DE&authNr=68291&supportMultipleResults=1"^^xsd:anyURI ;
fhir:l <https://Swissmedicinfo.ch/showText.aspx?textType=FI&lang=DE&authNr=68291&supportMultipleResults=1>       ]     ]
  ] ) . # 

<http://fhir.ch-idmp.smc.admin.ch/RegulatedAuthorisation/MA-6829103> a fhir:RegulatedAuthorization ;
  fhir:id [ fhir:v "MA-6829103"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-regulatedauthorization"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-regulatedauthorization>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div [ fhir:v "<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 --&gt; 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>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:contained ( [
a fhir:Organization ;
fhir:id [ fhir:v "holder-Astellas-Pharma-AG" ] ;
fhir:meta [
      ( fhir:profile [
fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization>       ] )     ] ;
    ( fhir:identifier [
fhir:system [
fhir:v "https://www.swissmedic.ch/fhir/identifier/locations"^^xsd:anyURI ;
fhir:l <https://www.swissmedic.ch/fhir/identifier/locations>       ] ;
fhir:value [ fhir:v "01100869" ]     ] [
fhir:system [
fhir:v "https://spor.ema.europa.eu/v1/locations"^^xsd:anyURI ;
fhir:l <https://spor.ema.europa.eu/v1/locations>       ] ;
fhir:value [ fhir:v "100010745" ]     ] [
fhir:system [
fhir:v "urn:oid:2.51.1.3"^^xsd:anyURI ;
fhir:l <urn:oid:2.51.1.3>       ] ;
fhir:value [ fhir:v "7601001000964" ]     ] ) ;
fhir:name [ fhir:v "Astellas Pharma AG" ]
  ] [
a fhir:Organization ;
fhir:id [ fhir:v "regulator-SMC" ] ;
fhir:meta [
      ( fhir:profile [
fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization>       ] )     ] ;
    ( fhir:identifier [
fhir:system [
fhir:v "https://spor.ema.europa.eu/v1/locations"^^xsd:anyURI ;
fhir:l <https://spor.ema.europa.eu/v1/locations>       ] ;
fhir:value [ fhir:v "100010911" ]     ] [
fhir:system [
fhir:v "urn:oid:2.51.1.3"^^xsd:anyURI ;
fhir:l <urn:oid:2.51.1.3>       ] ;
fhir:value [ fhir:v "7601001398511" ]     ] ) ;
fhir:name [ fhir:v "SMC" ]
  ] ) ; # 
  fhir:identifier ( [
fhir:system [
fhir:v "http://fhir.ch/ig/ch-idmp/sid/authno"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/sid/authno>     ] ;
fhir:value [ fhir:v "6829103" ]
  ] ) ; # 
  fhir:subject ( [
fhir:l fhir:MedicinalProductDefinition/Padcev-20mg-Powder ;
fhir:reference [ fhir:v "MedicinalProductDefinition/Padcev-20mg-Powder" ]
  ] ) ; # 
  fhir:type [
    ( fhir:coding [
fhir:system [
fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-authorisation-type-cs"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-authorisation-type-cs>       ] ;
fhir:code [ fhir:v "756000002001" ] ;
fhir:display [ fhir:v "Marketing Authorisation" ]     ] )
  ] ; # 
  fhir:region ( [
    ( fhir:coding [
fhir:system [
fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ;
fhir:l <urn:iso:std:iso:3166>       ] ;
fhir:code [ fhir:v "CH" ] ;
fhir:display [ fhir:v "Switzerland" ]     ] )
  ] ) ; # 
  fhir:status [
    ( fhir:coding [
fhir:system [
fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-authorisation-status"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-authorisation-status>       ] ;
fhir:code [ fhir:v "756005010000001" ] ;
fhir:display [ fhir:v "approved" ]     ] )
  ] ; # 
  fhir:statusDate [ fhir:v "2021-11-09"^^xsd:date] ; # 
  fhir:validityPeriod [
fhir:start [ fhir:v "2021-11-09"^^xsd:date ] ;
fhir:end [ fhir:v "2026-11-08"^^xsd:date ]
  ] ; # 
  fhir:holder [
fhir:l <#holder-Astellas-Pharma-AG> ;
fhir:reference [ fhir:v "#holder-Astellas-Pharma-AG" ]
  ] ; # 
  fhir:regulator [
fhir:l <#regulator-SMC> ;
fhir:reference [ fhir:v "#regulator-SMC" ]
  ] . # 

<http://fhir.ch-idmp.smc.admin.ch/PackagedProductDefinition/PMP-Enfortumabum-vedotinum-20-Powder> a fhir:PackagedProductDefinition ;
  fhir:id [ fhir:v "PMP-Enfortumabum-vedotinum-20-Powder"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-packagedproductdefinition"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-packagedproductdefinition>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div [ fhir:v "<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>\n</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 --&gt; (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>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:identifier ( [
fhir:system [
fhir:v "http://fhir.ch/ig/ch-idmp/sid/pcid"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/sid/pcid>     ] ;
fhir:value [ fhir:v "CH-01100869-0682910030000-0001" ]
  ] ) ; # 
  fhir:packageFor ( [
fhir:l fhir:MedicinalProductDefinition/Padcev-20mg-Powder ;
fhir:reference [ fhir:v "MedicinalProductDefinition/Padcev-20mg-Powder" ]
  ] ) ; # 
  fhir:containedItemQuantity ( [
fhir:value [ fhir:v "20"^^xsd:decimal ] ;
fhir:unit [ fhir:v "mg" ] ;
fhir:system [
fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ;
fhir:l <http://unitsofmeasure.org>     ] ;
fhir:code [ fhir:v "mg" ]
  ] ) ; # 
  fhir:description [ fhir:v "Durchstechflasche 1 Stk"] ; # 
  fhir:legalStatusOfSupply ( [
fhir:code [
      ( fhir:coding [
fhir:system [
fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-legal-status-of-supply"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-legal-status-of-supply>         ] ;
fhir:code [ fhir:v "756005034000001" ] ;
fhir:display [ fhir:v "A: Single dispensing requiring a medical or veterinary prescription" ]       ] )     ]
  ] ) ; # 
  fhir:marketingStatus ( [
fhir:country [
      ( fhir:coding [
fhir:system [
fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ;
fhir:l <urn:iso:std:iso:3166>         ] ;
fhir:code [ fhir:v "CH" ] ;
fhir:display [ fhir:v "Switzerland" ]       ] )     ] ;
fhir:status [
      ( fhir:coding [
fhir:system [
fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-Refdata-marketing-status"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-Refdata-marketing-status>         ] ;
fhir:code [ fhir:v "756002026002" ] ;
fhir:display [ fhir:v "Marketed" ]       ] )     ] ;
fhir:dateRange [
fhir:start [ fhir:v "2011-09-11"^^xsd:date ]     ]
  ] ) ; # 
  fhir:packaging [
    ( fhir:identifier [
fhir:system [
fhir:v "https://www.gs1.org/gtin"^^xsd:anyURI ;
fhir:l <https://www.gs1.org/gtin>       ] ;
fhir:value [ fhir:v "7680682910021" ]     ] ) ;
fhir:type [
      ( fhir:coding [
fhir:system [
fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ;
fhir:l <http://standardterms.edqm.eu>         ] ;
fhir:code [ fhir:v "30009000" ] ;
fhir:display [ fhir:v "Box" ]       ] )     ] ;
fhir:quantity [ fhir:v 6 ] ;
    ( fhir:shelfLifeStorage [
fhir:type [
        ( fhir:coding [
fhir:system [
fhir:v "http://spor.ema.europa.eu/v1/lists/100000073343"^^xsd:anyURI ;
fhir:l <http://spor.ema.europa.eu/v1/lists/100000073343>           ] ;
fhir:code [ fhir:v "100000073405" ] ;
fhir:display [ fhir:v "Shelf life after dilution or reconstitution according to directions" ]         ] )       ] ;
fhir:period [
a fhir:Duration ;
fhir:value [ fhir:v "16"^^xsd:decimal ] ;
fhir:unit [ fhir:v "hour" ] ;
fhir:system [
fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ;
fhir:l <http://unitsofmeasure.org>         ] ;
fhir:code [ fhir:v "h" ]       ] ;
      ( fhir:specialPrecautionsForStorage [
        ( fhir:coding [
fhir:system [
fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-special-precautions-for-storage"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-special-precautions-for-storage>           ] ;
fhir:code [ fhir:v "756005041000011" ] ;
fhir:display [ fhir:v "Store in the original container" ]         ] )       ] )     ] ) ;
    ( fhir:packaging [
fhir:type [
        ( fhir:coding [
fhir:system [
fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ;
fhir:l <http://standardterms.edqm.eu>           ] ;
fhir:code [ fhir:v "30069000" ] ;
fhir:display [ fhir:v "Vial" ]         ] )       ] ;
fhir:quantity [ fhir:v 1 ] ;
      ( fhir:containedItem [
fhir:item [
fhir:reference [
fhir:l fhir:ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-30-Powder ;
fhir:reference [ fhir:v "ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-30-Powder" ]           ]         ] ;
fhir:amount [
fhir:value [ fhir:v "20"^^xsd:decimal ] ;
fhir:unit [ fhir:v "mg" ] ;
fhir:system [
fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ;
fhir:l <http://unitsofmeasure.org>           ] ;
fhir:code [ fhir:v "mg" ]         ]       ] )     ] )
  ] . # 

<http://fhir.ch-idmp.smc.admin.ch/RegulatedAuthorisation/MA-68291001> a fhir:RegulatedAuthorization ;
  fhir:id [ fhir:v "MA-68291001"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-regulatedauthorization"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-regulatedauthorization>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div [ fhir:v "<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 --&gt; 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>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:contained ( [
a fhir:Organization ;
fhir:id [ fhir:v "holder-Astellas-Pharma-AG" ] ;
fhir:meta [
      ( fhir:profile [
fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization>       ] )     ] ;
    ( fhir:identifier [
fhir:system [
fhir:v "https://www.swissmedic.ch/fhir/identifier/locations"^^xsd:anyURI ;
fhir:l <https://www.swissmedic.ch/fhir/identifier/locations>       ] ;
fhir:value [ fhir:v "01100869" ]     ] [
fhir:system [
fhir:v "https://spor.ema.europa.eu/v1/locations"^^xsd:anyURI ;
fhir:l <https://spor.ema.europa.eu/v1/locations>       ] ;
fhir:value [ fhir:v "100010745" ]     ] [
fhir:system [
fhir:v "urn:oid:2.51.1.3"^^xsd:anyURI ;
fhir:l <urn:oid:2.51.1.3>       ] ;
fhir:value [ fhir:v "7601001000964" ]     ] ) ;
fhir:name [ fhir:v "Astellas Pharma AG" ]
  ] [
a fhir:Organization ;
fhir:id [ fhir:v "regulator-SMC" ] ;
fhir:meta [
      ( fhir:profile [
fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization>       ] )     ] ;
    ( fhir:identifier [
fhir:system [
fhir:v "https://spor.ema.europa.eu/v1/locations"^^xsd:anyURI ;
fhir:l <https://spor.ema.europa.eu/v1/locations>       ] ;
fhir:value [ fhir:v "100010911" ]     ] [
fhir:system [
fhir:v "urn:oid:2.51.1.3"^^xsd:anyURI ;
fhir:l <urn:oid:2.51.1.3>       ] ;
fhir:value [ fhir:v "7601001398511" ]     ] ) ;
fhir:name [ fhir:v "SMC" ]
  ] ) ; # 
  fhir:identifier ( [
fhir:system [
fhir:v "http://fhir.ch/ig/ch-idmp/sid/authno"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/sid/authno>     ] ;
fhir:value [ fhir:v "68291001" ]
  ] ) ; # 
  fhir:subject ( [
fhir:l fhir:PackagedProductDefinition/PMP-Enfortumabum-vedotinum-20-Powder ;
fhir:reference [ fhir:v "PackagedProductDefinition/PMP-Enfortumabum-vedotinum-20-Powder" ]
  ] ) ; # 
  fhir:type [
    ( fhir:coding [
fhir:system [
fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-authorisation-type-cs"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-authorisation-type-cs>       ] ;
fhir:code [ fhir:v "756000002001" ] ;
fhir:display [ fhir:v "Marketing Authorisation" ]     ] )
  ] ; # 
  fhir:region ( [
    ( fhir:coding [
fhir:system [
fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ;
fhir:l <urn:iso:std:iso:3166>       ] ;
fhir:code [ fhir:v "CH" ] ;
fhir:display [ fhir:v "Switzerland" ]     ] )
  ] ) ; # 
  fhir:status [
    ( fhir:coding [
fhir:system [
fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-authorisation-status"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-authorisation-status>       ] ;
fhir:code [ fhir:v "756005010000001" ] ;
fhir:display [ fhir:v "approved" ]     ] )
  ] ; # 
  fhir:statusDate [ fhir:v "2021-11-09"^^xsd:date] ; # 
  fhir:validityPeriod [
fhir:start [ fhir:v "2021-11-09"^^xsd:date ] ;
fhir:end [ fhir:v "2026-11-08"^^xsd:date ]
  ] ; # 
  fhir:holder [
fhir:l <#holder-Astellas-Pharma-AG> ;
fhir:reference [ fhir:v "#holder-Astellas-Pharma-AG" ]
  ] ; # 
  fhir:regulator [
fhir:l <#regulator-SMC> ;
fhir:reference [ fhir:v "#regulator-SMC" ]
  ] . # 

<http://fhir.ch-idmp.smc.admin.ch/ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-20-Powder> a fhir:ManufacturedItemDefinition ;
  fhir:id [ fhir:v "MI-Enfortumabum-vedotinum-20-Powder"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-manufactureditemdefinition"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-manufactureditemdefinition>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:manufacturedDoseForm [
    ( fhir:coding [
fhir:system [
fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ;
fhir:l <http://standardterms.edqm.eu>       ] ;
fhir:code [ fhir:v "11215000" ] ;
fhir:display [ fhir:v "Lyophilisate for solution for infusion" ]     ] )
  ] ; # 
  fhir:unitOfPresentation [
    ( fhir:coding [
fhir:system [
fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ;
fhir:l <http://standardterms.edqm.eu>       ] ;
fhir:code [ fhir:v "15060000" ] ;
fhir:display [ fhir:v "Vial" ]     ] )
  ] . # 

<http://fhir.ch-idmp.smc.admin.ch/AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution> a fhir:AdministrableProductDefinition ;
  fhir:id [ fhir:v "PhP-Enfortumabum-vedotinum-20-Solution"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-administrableproductdefinition"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-administrableproductdefinition>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:formOf ( [
fhir:l fhir:MedicinalProductDefinition/Padcev-20mg-Powder ;
fhir:reference [ fhir:v "MedicinalProductDefinition/Padcev-20mg-Powder" ]
  ] ) ; # 
  fhir:administrableDoseForm [
    ( fhir:coding [
fhir:system [
fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ;
fhir:l <http://standardterms.edqm.eu>       ] ;
fhir:code [ fhir:v "11210000" ] ;
fhir:display [ fhir:v "Solution for Infusion" ]     ] )
  ] ; # 
  fhir:unitOfPresentation [
    ( fhir:coding [
fhir:system [
fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ;
fhir:l <http://standardterms.edqm.eu>       ] ;
fhir:code [ fhir:v "15060000" ] ;
fhir:display [ fhir:v "Vial" ]     ] )
  ] ; # 
  fhir:routeOfAdministration ( [
fhir:code [
      ( fhir:coding [
fhir:system [
fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ;
fhir:l <http://standardterms.edqm.eu>         ] ;
fhir:code [ fhir:v "20045000" ] ;
fhir:display [ fhir:v "Intravenous use" ]       ] )     ]
  ] ) . # 

<http://fhir.ch-idmp.smc.admin.ch/Ingredient/EnfortumabumVedotinum20> a fhir:Ingredient ;
  fhir:id [ fhir:v "EnfortumabumVedotinum20"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:for ( [
fhir:l fhir:AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution ;
fhir:reference [ fhir:v "AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution" ]
  ] [
fhir:l fhir:ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-20-Powder ;
fhir:reference [ fhir:v "ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-20-Powder" ]
  ] ) ; # 
  fhir:role [
    ( fhir:coding [
fhir:system [
fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role>       ] ;
fhir:code [ fhir:v "756005035000001" ] ;
fhir:display [ fhir:v "Active" ]     ] )
  ] ; # 
  fhir:substance [
fhir:code [
fhir:concept [
        ( fhir:coding [
fhir:system [
fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance>           ] ;
fhir:code [ fhir:v "DLE8519RWM" ] ;
fhir:display [ fhir:v "Enfortumab vedotin" ]         ] )       ]     ] ;
    ( fhir:strength [
fhir:presentation [
a fhir:Ratio ;
fhir:numerator [
fhir:value [ fhir:v "20"^^xsd:decimal ] ;
fhir:unit [ fhir:v "mg" ] ;
fhir:system [
fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ;
fhir:l <http://unitsofmeasure.org>           ] ;
fhir:code [ fhir:v "mg" ]         ] ;
fhir:denominator [
fhir:value [ fhir:v "1"^^xsd:decimal ] ;
fhir:unit [ fhir:v "vial" ] ;
fhir:system [
fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ;
fhir:l <http://standardterms.edqm.eu>           ] ;
fhir:code [ fhir:v "15060000" ]         ]       ] ;
      ( fhir:referenceStrength [
fhir:substance [
fhir:concept [
            ( fhir:coding [
fhir:system [
fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance>               ] ;
fhir:code [ fhir:v "DLE8519RWM" ] ;
fhir:display [ fhir:v "Enfortumab vedotin" ]             ] )           ]         ] ;
fhir:strength [
a fhir:Ratio ;
fhir:numerator [
fhir:value [ fhir:v "20"^^xsd:decimal ] ;
fhir:unit [ fhir:v "mg" ] ;
fhir:system [
fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ;
fhir:l <http://unitsofmeasure.org>             ] ;
fhir:code [ fhir:v "mg" ]           ] ;
fhir:denominator [
fhir:value [ fhir:v "1"^^xsd:decimal ] ;
fhir:unit [ fhir:v "vial" ] ;
fhir:system [
fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ;
fhir:l <http://standardterms.edqm.eu>             ] ;
fhir:code [ fhir:v "15060000" ]           ]         ]       ] )     ] )
  ] . # 

<http://fhir.ch-idmp.smc.admin.ch/Ingredient/Histidinum> a fhir:Ingredient ;
  fhir:id [ fhir:v "Histidinum"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:for ( [
fhir:l fhir:AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution ;
fhir:reference [ fhir:v "AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution" ]
  ] [
fhir:l fhir:ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-20-Powder ;
fhir:reference [ fhir:v "ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-20-Powder" ]
  ] [
fhir:l fhir:AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-30-Solution ;
fhir:reference [ fhir:v "AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-30-Solution" ]
  ] [
fhir:l fhir:ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-30-Powder ;
fhir:reference [ fhir:v "ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-30-Powder" ]
  ] ) ; # 
  fhir:role [
    ( fhir:coding [
fhir:system [
fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role>       ] ;
fhir:code [ fhir:v "756005035000002" ] ;
fhir:display [ fhir:v "Excipient" ]     ] )
  ] ; # 
  fhir:substance [
fhir:code [
fhir:concept [
        ( fhir:coding [
fhir:system [
fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance>           ] ;
fhir:code [ fhir:v "4QD397987E" ] ;
fhir:display [ fhir:v "Histidine" ]         ] )       ]     ]
  ] . # 

<http://fhir.ch-idmp.smc.admin.ch/Ingredient/HistidiniHydrochloridumMonohydricum> a fhir:Ingredient ;
  fhir:id [ fhir:v "HistidiniHydrochloridumMonohydricum"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:for ( [
fhir:l fhir:AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution ;
fhir:reference [ fhir:v "AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution" ]
  ] [
fhir:l fhir:ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-20-Powder ;
fhir:reference [ fhir:v "ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-20-Powder" ]
  ] [
fhir:l fhir:AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-30-Solution ;
fhir:reference [ fhir:v "AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-30-Solution" ]
  ] [
fhir:l fhir:ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-30-Powder ;
fhir:reference [ fhir:v "ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-30-Powder" ]
  ] ) ; # 
  fhir:role [
    ( fhir:coding [
fhir:system [
fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role>       ] ;
fhir:code [ fhir:v "756005035000002" ] ;
fhir:display [ fhir:v "Excipient" ]     ] )
  ] ; # 
  fhir:substance [
fhir:code [
fhir:concept [
        ( fhir:coding [
fhir:system [
fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance>           ] ;
fhir:code [ fhir:v "X573657P6P" ] ;
fhir:display [ fhir:v "Histidine hydrochloride monohydrate" ]         ] )       ]     ]
  ] . # 

<http://fhir.ch-idmp.smc.admin.ch/Ingredient/TrehalosumDihydricum> a fhir:Ingredient ;
  fhir:id [ fhir:v "TrehalosumDihydricum"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:for ( [
fhir:l fhir:AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution ;
fhir:reference [ fhir:v "AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution" ]
  ] [
fhir:l fhir:ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-20-Powder ;
fhir:reference [ fhir:v "ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-20-Powder" ]
  ] [
fhir:l fhir:AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-30-Solution ;
fhir:reference [ fhir:v "AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-30-Solution" ]
  ] [
fhir:l fhir:ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-30-Powder ;
fhir:reference [ fhir:v "ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-30-Powder" ]
  ] ) ; # 
  fhir:role [
    ( fhir:coding [
fhir:system [
fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role>       ] ;
fhir:code [ fhir:v "756005035000002" ] ;
fhir:display [ fhir:v "Excipient" ]     ] )
  ] ; # 
  fhir:substance [
fhir:code [
fhir:concept [
        ( fhir:coding [
fhir:system [
fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance>           ] ;
fhir:code [ fhir:v "7YIN7J07X4" ] ;
fhir:display [ fhir:v "Trehalose dihydrate" ]         ] )       ]     ]
  ] . # 

<http://fhir.ch-idmp.smc.admin.ch/Ingredient/Polysorbatum20> a fhir:Ingredient ;
  fhir:id [ fhir:v "Polysorbatum20"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:for ( [
fhir:l fhir:AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution ;
fhir:reference [ fhir:v "AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution" ]
  ] [
fhir:l fhir:ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-20-Powder ;
fhir:reference [ fhir:v "ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-20-Powder" ]
  ] [
fhir:l fhir:AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-30-Solution ;
fhir:reference [ fhir:v "AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-30-Solution" ]
  ] [
fhir:l fhir:ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-30-Powder ;
fhir:reference [ fhir:v "ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-30-Powder" ]
  ] ) ; # 
  fhir:role [
    ( fhir:coding [
fhir:system [
fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role>       ] ;
fhir:code [ fhir:v "756005035000002" ] ;
fhir:display [ fhir:v "Excipient" ]     ] )
  ] ; # 
  fhir:substance [
fhir:code [
fhir:concept [
        ( fhir:coding [
fhir:system [
fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance>           ] ;
fhir:code [ fhir:v "7T1F30V5YH" ] ;
fhir:display [ fhir:v "Polysorbate 20" ]         ] )       ]     ]
  ] . # 

<http://fhir.ch-idmp.smc.admin.ch/Ingredient/AquaAdIniectabile> a fhir:Ingredient ;
  fhir:id [ fhir:v "AquaAdIniectabile"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:for ( [
fhir:l fhir:AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution ;
fhir:reference [ fhir:v "AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution" ]
  ] [
fhir:l fhir:AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-30-Solution ;
fhir:reference [ fhir:v "AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-30-Solution" ]
  ] ) ; # 
  fhir:role [
    ( fhir:coding [
fhir:system [
fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role>       ] ;
fhir:code [ fhir:v "756005035000002" ] ;
fhir:display [ fhir:v "Excipient" ]     ] )
  ] ; # 
  fhir:substance [
fhir:code [
fhir:concept [
        ( fhir:coding [
fhir:system [
fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance>           ] ;
fhir:code [ fhir:v "059QF0KO0R" ] ;
fhir:display [ fhir:v "Water" ]         ] )       ]     ]
  ] . # 

<http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10057352> a fhir:ClinicalUseDefinition ;
  fhir:id [ fhir:v "IND-10057352"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:type [ fhir:v "indication"] ; # 
  fhir:subject ( [
fhir:l fhir:MedicinalProductDefinition/Padcev-20mg-Powder ;
fhir:reference [ fhir:v "MedicinalProductDefinition/Padcev-20mg-Powder" ]
  ] ) ; # 
  fhir:indication [
fhir:diseaseSymptomProcedure [
fhir:concept [
        ( fhir:coding [
fhir:system [
fhir:v "https://www.meddra.org"^^xsd:anyURI ;
fhir:l <https://www.meddra.org>           ] ;
fhir:code [ fhir:v "10057352" ] ;
fhir:display [ fhir:v "Metastatic carcinoma of the bladder" ]         ] )       ]     ] ;
fhir:intendedEffect [
fhir:concept [
        ( fhir:coding [
fhir:system [
fhir:v "http://spor.ema.europa.eu/v1/lists/200000003186"^^xsd:anyURI ;
fhir:l <http://spor.ema.europa.eu/v1/lists/200000003186>           ] ;
fhir:code [ fhir:v "756005042000002" ] ;
fhir:display [ fhir:v "therapeutic" ]         ] )       ]     ]
  ] . #