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

Example PackagedProductDefinition: CH-56891003

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

-CountryStatusDateRange
*SwitzerlandMarketed2020-09-24 --> (ongoing)

packaging

identifier: GTIN Global Trade Item Number/7680672110011

type: Box

quantity: 1

ShelfLifeStorages

-TypePeriod[x]SpecialPrecautionsForStorage
*Shelf life of the medicinal product as packaged for saleNo display for Duration (value: 36; unit: month; system: http://unitsofmeasure.org; code: mo)Do not store above 30°C

packaging

type: Blister

quantity: 4

containedItem

Items

-Reference
*ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet

amount: 12 countable unit(s) (Details: UCUM code1 = '1')