CH IDMP (R5)
1.0.0-ballot - ballot
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
{
"resourceType" : "ClinicalUseDefinition",
"id" : "IND-10057352",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication"
]
},
"text" : {
"status" : "generated",
"div" : "<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>"
},
"type" : "indication",
"subject" : [
{
🔗 "reference" : "MedicinalProductDefinition/Padcev-20mg-Powder"
}
],
"indication" : {
"diseaseSymptomProcedure" : {
"concept" : {
"coding" : [
{
"system" : "https://www.meddra.org",
"code" : "10057352",
"display" : "Metastatic carcinoma of the bladder"
}
]
}
},
"intendedEffect" : {
"concept" : {
"coding" : [
{
"system" : "http://spor.ema.europa.eu/v1/lists/200000003186",
"code" : "756005042000002",
"display" : "therapeutic"
}
]
}
}
}
}