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:MedicinalProductDefinition ;
fhir:nodeRole fhir:treeRoot ;
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\"><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 --> (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" ] ] ) ] ] )
] ) . #
IG © 2026+ Refdata Foundation. Package ch.fhir.ig.ch-idmp#1.0.0-ballot based on FHIR 5.0.0. Generated 2026-06-12
Links: Table of Contents |
QA Report
| Propose a change