CH IDMP (R5)
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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

: 6829104 - 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:RegulatedAuthorization ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "MA-6829104"] ; # 
  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\"><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization MA-6829104</b></p><a name=\"MA-6829104\"> </a><a name=\"hcMA-6829104\"> </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>/6829104</p><p><b>subject</b>: <a href=\"MedicinalProductDefinition-Padcev-30mg-Powder.html\">MedicinalProductDefinition: extension = Lyophilisate for solution for infusion; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#Medical Product Identifier#CH-01100869-0682910040000; 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-6829104/holder-Astellas-Pharma-AG\">Organization Astellas Pharma AG</a></p><p><b>regulator</b>: <a href=\"#hcMA-6829104/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-6829104/holder-Astellas-Pharma-AG\"> </a><a name=\"hcMA-6829104/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-6829104/regulator-SMC\"> </a><a name=\"hcMA-6829104/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 "6829104" ]
  ] ) ; # 
  fhir:subject ( [
fhir:l fhir:MedicinalProductDefinition/Padcev-30mg-Powder ;
fhir:reference [ fhir:v "MedicinalProductDefinition/Padcev-30mg-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" ]
  ] . #