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

: Indication 10057352 - XML Representation

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<ClinicalUseDefinition xmlns="http://hl7.org/fhir">
  <id value="IND-10057352"/>
  <meta>
    <profile
             value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication"/>
  </meta>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: ClinicalUseDefinition IND-10057352</b></p><a name="IND-10057352"> </a><a name="hcIND-10057352"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ch-idmp-clinicalusedefinition-indication.html">ClinicalUseDefinition Indication</a></p></div><p><b>type</b>: Indication</p><p><b>subject</b>: <a href="MedicinalProductDefinition-Padcev-20mg-Powder.html">MedicinalProductDefinition: extension = Lyophilisate for solution for infusion; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#Medical Product Identifier#CH-01100869-0682910030000; indication = Padcev ist indiziert zur Behandlung von Erwachsenen mit lokal fortgeschrittenem oder metastasiertem Urothelkarzinom (mUC), die eine platinhaltige Chemotherapie im neoadjuvanten/adjuvanten, lokal fortgeschrittenen oder metastasierten Setting erhalten haben und die während oder nach der Behandlung mit einem Inhibitor des programmierten Zelltodrezeptors-1 (PD-1) oder des programmierten Zelltod-Liganden 1 (PD-L1) einen Progress oder einen Rückfall der Erkrankung erlitten haben.; legalStatusOfSupply = A: Single dispensing requiring a medical or veterinary prescription; additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Not authorised for the treatment in children; classification = gilteritinib,NA KAS art. 12 para. 5 TPLO,Biologics</a></p><blockquote><p><b>indication</b></p><h3>DiseaseSymptomProcedures</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://www.meddra.org 10057352}">Metastatic carcinoma of the bladder</span></td></tr></table><h3>IntendedEffects</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://spor.ema.europa.eu/v1/lists/200000003186 756005042000002}">therapeutic</span></td></tr></table></blockquote></div>
  </text>
  <type value="indication"/>
  <subject>🔗 
    <reference value="MedicinalProductDefinition/Padcev-20mg-Powder"/>
  </subject>
  <indication>
    <diseaseSymptomProcedure>
      <concept>
        <coding>
          <system value="https://www.meddra.org"/>
          <code value="10057352"/>
          <display value="Metastatic carcinoma of the bladder"/>
        </coding>
      </concept>
    </diseaseSymptomProcedure>
    <intendedEffect>
      <concept>
        <coding>
          <system value="http://spor.ema.europa.eu/v1/lists/200000003186"/>
          <code value="756005042000002"/>
          <display value="therapeutic"/>
        </coding>
      </concept>
    </intendedEffect>
  </indication>
</ClinicalUseDefinition>