PMP-Enfortumabum-vedotinum-20-Powder
type: PackagedProductDefinition
node role: treeRoot
id:
  v: PMP-Enfortumabum-vedotinum-20-Powder
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-packagedproductdefinition
    l: ch-idmp-packagedproductdefinition
text:
  status:
    v: generated
  div:
    v: Generated Narrative: PackagedProductDefinition PMP-Enfortumabum-vedotinum-20-Powder Profile: PackagedProductDefinition identifier: Clinical Product Identifier/CH-01100869-0682910030000-0001 packageFor: 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 containedItemQuantity: 20 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/7680682910021 type: Box quantity:…
identifier:
  system:
    v: http://fhir.ch/ig/ch-idmp/sid/pcid
    l: pcid
  value:
    v: CH-01100869-0682910030000-0001
package for:
  l: Padcev-20mg-Powder
  reference:
    v: MedicinalProductDefinition/Padcev-20mg-Powder
contained item quantity:
  value:
    v: 20
  unit:
    v: mg
  system:
    v: http://unitsofmeasure.org
    l: unitsofmeasure.org
  code:
    v: mg
description:
  v: Durchstechflasche 1 Stk
legal status of supply:
  code:
    coding:
      system:
        v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-legal-status-of-supply
        l: ch-SMC-legal-status-of-supply
      code:
        v: 756005034000001
      display:
        v: A: Single dispensing requiring a medical or veterinary prescription
marketing status:
  country:
    coding:
      system:
        v: urn:iso:std:iso:3166
        l: 3166
      code:
        v: CH
      display:
        v: Switzerland
  status:
    coding:
      system:
        v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-Refdata-marketing-status
        l: ch-Refdata-marketing-status
      code:
        v: 756002026002
      display:
        v: Marketed
  date range:
    start:
      v: 2011-09-11
packaging:
  identifier:
    system:
      v: https://www.gs1.org/gtin
      l: gtin
    value:
      v: 7680682910021
  type:
    coding:
      system:
        v: http://standardterms.edqm.eu
        l: standardterms.edqm.eu
      code:
        v: 30009000
      display:
        v: Box
  quantity:
    v: 6
  shelf life storage:
    period: Duration
      value:
        v: 16
      unit:
        v: hour
      system:
        v: http://unitsofmeasure.org
        l: unitsofmeasure.org
      code:
        v: h
  packaging:
    quantity:
      v: 1

v: 100000073405

v: Shelf life after dilution or reconstitution according to directions

v: 756005041000011

v: Store in the original container

v: 30069000

v: Vial

l: MI-Enfortumabum-vedotinum-30-Powder
reference:
  v: ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-30-Powder

v: 20

v: mg

v: mg