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
@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:ClinicalUseDefinition ;
fhir:nodeRole fhir:treeRoot ;
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\"><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" ] ] ) ] ]
] . #
IG © 2026+ Refdata Foundation. Package ch.fhir.ig.ch-idmp#1.0.0-ballot based on FHIR 5.0.0. Generated 2026-06-12
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