Generated Narrative: PackagedProductDefinition PMP-Enfortumabum-vedotinum-30-Powder Profile: PackagedProductDefinition identifier: Clinical Product Identifier/CH-01100869-0682910040000-0002 packageFor: 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 containedItemQuantity: 30 mg (Details: UCUM codemg = 'mg') description: Durchstechflasche 1 Stk LegalStatusOfSupplies - Code * A: Single dispensing requiring a medical or veterinary prescription MarketingStatuses - Country Status DateRange * Switzerland Marketed 2011-09-11 --> (ongoing) packaging identifier: <a href="http://terminology.hl7.org/7.1.0/NamingSystem-gtin.html" title="The GS1 GTIN is a globally unique identifier of trade items. A trade item is any item (product or service) upon which there is a need to retrieve pre-defined information and that may be priced, or ordered, or invoiced at any point in any supply chain. Note: GTINs may be used in both Codes (http://build.fhir.org/datatypes.html#Coding) and Identifiers (http://build.fhir.org/datatypes.html#Identifier).">GTIN Global Trade Item Number/7680682910014 type: Box quantity: 1 ShelfLifeStorages - Type Period[x] SpecialPrecautionsForStorage * Shelf life after dilution or reconstitution according to directions No display for Duration (value: 16; unit: hour; system: http://unitsofmeasure.org; code: h) Store in the original container packaging type: Vial quantity: 1 containedItem Items - Reference * ManufacturedItemDefinition: status = active; manufacturedDoseForm = Lyophilisate for solution for infusion; unitOfPresentation = Vial amount: 30 mg (Details: UCUM codemg = 'mg')
A: Single dispensing requiring a medical or veterinary prescription
Shelf life after dilution or reconstitution according to directions