PMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
type: PackagedProductDefinition
node role: treeRoot
id:
  v: PMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
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-Gilteritinibi-hemifumaras-40-Filmcoatedtablet Profile: PackagedProductDefinition identifier: Clinical Product Identifier/CH-01100869-0672110010000-0001 packageFor: MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#Medical Product Identifier#CH-01100869-0672110010000; indication = Xospata wird angewendet für die Behandlung von erwachsenen Patienten, die an rezidivierter oder refraktärer akuter myeloider Leukämie (AML) mit FMS-ähnlichen Tyrosinkinase 3 (FLT3)-Mutationen leiden.; legalStatusOfSupply = A: Single dispensing requiring a medical or veterinary prescription; additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Not authorised for the treatment in children; classification = gilteritinib,Synthetic containedItemQuantity: 48 Tablet (Details: EDQM - Standard Terms code15054000 = 'Tablet') description: 4 Blister zu 7 Tabletten in 1 Box LegalStatusOfSupplies - Code * A: Single dispensing requiring a medical or veterinary prescription MarketingStatuses - Country Status DateRange * Switzerland Marketed 2020-09-24 --> (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/7680672110011 type: Box quantity: 1 ShelfLifeStorages - Type Period[x] SpecialPrecautionsForStorage * Shelf life of the medicinal product as packaged for sale No display for Duration (value: 36; unit: month; system: http://unitsofmeasure.org; code: mo) Do not store above 30°C packaging type: Blister quant…
identifier:
  system:
    v: http://fhir.ch/ig/ch-idmp/sid/pcid
    l: pcid
  value:
    v: CH-01100869-0672110010000-0001
package for:
  l: Xospata-Filmcoatedtablet
  reference:
    v: MedicinalProductDefinition/Xospata-Filmcoatedtablet
contained item quantity:
  value:
    v: 48
  unit:
    v: Tablet
  system:
    v: http://standardterms.edqm.eu
    l: standardterms.edqm.eu
  code:
    v: 15054000
description:
  v: 4 Blister zu 7 Tabletten in 1 Box
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: 2020-09-24
packaging:
  identifier:
    system:
      v: https://www.gs1.org/gtin
      l: gtin
    value:
      v: 7680672110011
  type:
    coding:
      system:
        v: http://standardterms.edqm.eu
        l: standardterms.edqm.eu
      code:
        v: 30009000
      display:
        v: Box
  quantity:
    v: 1
  shelf life storage:
    period: Duration
      value:
        v: 36
      unit:
        v: month
      system:
        v: http://unitsofmeasure.org
        l: unitsofmeasure.org
      code:
        v: mo
  packaging:
    quantity:
      v: 4

v: 100000073403

v: Shelf life of the medicinal product as packaged for sale

v: 756005041000009

v: Do not store above 30°C

v: 30007000

v: Blister

l: MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
reference:
  v: ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet

v: 12

v: countable unit(s)

v: 1