CH IDMP (R5)
1.0.0-ballot - trial-use
CH IDMP (R5)
1.0.0-ballot - trial-use
CH IDMP (R5) - Local Development build (v1.0.0-ballot) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
Language: de-CH
Profile: Bundle
Bundle ab55cf13-a819-4875-adaa-5545e2cbdddf of type collection
Entry 1 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/MedicinalProductDefinition/Xospata-Filmcoatedtablet
Resso}:
Profile: MedicinalProductDefinition
CH SMC - Authorized Dose Form: Film-coated tablet
identifier: 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
MarketingStatuses
Country Status DateRange Switzerland No interruption of distribution reported 2020-09-24 --> (ongoing) attachedDocument:
- DocumentReference: identifier = http://fhir.ch/ig/ch-idmp/sid/attno#Application / Assessment Tracking Number#123456989-initial submission-Example-xyz-123; status = current; type = Information for healthcare professionals; date = 2021-11-09 00:00:00+0000
- DocumentReference: identifier = http://fhir.ch/ig/ch-idmp/sid/attno#Application / Assessment Tracking Number#123456989-initial submission-Example-abc-123; status = current; type = Patient Information; date = 2021-11-09 00:00:00+0000
name
productName: Xospata 40 mg, Filmtabletten
Usages
Country Language Switzerland German (Switzerland)
Entry 2 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/DocumentReference/DocRef-FI-Xospata
Resso}:
Profile: DocumentReference
identifier: Application / Assessment Tracking Number/123456989-initial submission-Example-xyz-123
status: Current
type: Information for healthcare professionals
date: 2021-11-09 00:00:00+0000
content
Attachments
Url https://Swissmedicinfo.ch/showText.aspx?textType=FI&lang=DE&authNr=67211&supportMultipleResults=1
Entry 3 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/DocumentReference/DocRef-PI-Xospata
Resso}:
Profile: DocumentReference
identifier: Application / Assessment Tracking Number/123456989-initial submission-Example-abc-123
status: Current
type: Patient Information
date: 2021-11-09 00:00:00+0000
content
Attachments
Language Url de-CH https://Swissmedicinfo.ch/showText.aspx?textType=PI&lang=DE&authNr=67211&supportMultipleResults=1
Entry 4 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/RegulatedAuthorisation/MA-6721101
Resso}:
Profile: RegulatedAuthorization
identifier: Marketing Authorisation Number/6721101
type: Marketing Authorisation
region: Switzerland
status: approved
statusDate: 2021-11-09
validityPeriod: 2021-11-09 --> (ongoing)
holder: Organization Astellas Pharma AG
regulator: Organization SMC
Profile: Organization
identifier: Swissmedic Location Identifier/01100869, LOC Identifier/100010745, GLN Identifier/7601001000964
name: Astellas Pharma AG
Profile: Organization
identifier: LOC Identifier/100010911, GLN Identifier/7601001398511
name: SMC
Entry 5 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/PackagedProductDefinition/PMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
Resso}:
Profile: PackagedProductDefinition
identifier: Clinical Product Identifier/CH-01100869-0672110010000-0001
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: 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
quantity: 4
containedItem
Items
Reference ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet amount: 12 countable unit(s) (Details: UCUM code1 = '1')
Entry 6 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/RegulatedAuthorisation/MA-67211001
Resso}:
Profile: RegulatedAuthorization
identifier: Marketing Authorisation Number/67211001
type: Marketing Authorisation
region: Switzerland
status: approved
statusDate: 2021-11-09
validityPeriod: 2021-11-09 --> (ongoing)
holder: Organization Astellas Pharma AG
regulator: Organization SMC
Profile: Organization
identifier: Swissmedic Location Identifier/01100869, LOC Identifier/100010745, GLN Identifier/7601001000964
name: Astellas Pharma AG
Profile: Organization
identifier: LOC Identifier/100010911, GLN Identifier/7601001398511
name: SMC
Entry 7 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
Resso}:
Profile: ManufacturedItemDefinition
status: Active
manufacturedDoseForm: Film-coated tablet
unitOfPresentation: Tablet
Entry 8 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
Resso}:
Profile: AdministrableProductDefinition
status: Active
administrableDoseForm: Film-coated tablet
unitOfPresentation: Tablet
RouteOfAdministrations
Code Oral use
Entry 9 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/Ingredient/GilteritinibiHemifumaras40
Resso}:
Profile: Ingredient
status: Active
for:
- AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet
- ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet
role: Active
substance
Codes
Concept Gilteritinib fumarate strength
presentation: 44.2 mg (Details: UCUM codemg = 'mg')/1 tablet (Details: EDQM - Standard Terms code15054000 = 'Tablet')
referenceStrength
Substances
Concept Gilteritinib strength: 40 mg (Details: UCUM codemg = 'mg')/1 tablet (Details: EDQM - Standard Terms code15054000 = 'Tablet')
Entry 10 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/Ingredient/Mannitolum
Resso}:
Profile: Ingredient
status: Active
for:
- AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet
- ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet
role: Excipient
substance
Codes
Concept Mannitol
Entry 11 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/Ingredient/Hydroxypropylcellulosum
Resso}:
Profile: Ingredient
status: Active
for:
- AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet
- ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet
role: Excipient
substance
Codes
Concept Hyprolose
Entry 12 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/Ingredient/HydroxypropylcellulosumSubstitutumHumile
Resso}:
Profile: Ingredient
status: Active
for:
- AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet
- ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet
role: Excipient
substance
Codes
Concept Hydroxypropylcellulose, low-substituted
Entry 13 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/Ingredient/Talcum
Resso}:
Profile: Ingredient
status: Active
for:
- AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet
- ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet
role: Excipient
substance
Codes
Concept Talc
Entry 14 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/Ingredient/Macrogolum8000
Resso}:
Profile: Ingredient
status: Active
for:
- AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet
- ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet
role: Excipient
substance
Codes
Concept Macrogol 8000
Entry 15 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/Ingredient/E171
Resso}:
Profile: Ingredient
status: Active
for:
- AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet
- ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet
role: Excipient
substance
Codes
Concept Titanium dioxide
Entry 16 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/Ingredient/E172Flavum
Resso}:
Profile: Ingredient
status: Active
for:
- AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet
- ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet
role: Excipient
substance
Codes
Concept Titanium dioxide
Entry 17 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/Ingredient/MagnesiumStearate
Resso}:
Profile: Ingredient
status: Active
for:
- AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet
- ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet
role: Excipient
substance
Codes
Concept Magnesium stearate
Entry 18 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/Ingredient/Hypromellosum
Resso}:
Profile: Ingredient
status: Active
for:
- AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet
- ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet
role: Excipient
substance
Codes
Concept Hypromellose
Entry 19 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10081514
Resso}:
Profile: ClinicalUseDefinition Indication
type: Indication
indication
DiseaseSymptomProcedures
Concept Acute myeloid leukemia refractory IntendedEffects
Concept therapeutic
Entry 20 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10081513
Resso}:
Profile: ClinicalUseDefinition Indication
type: Indication
indication
DiseaseSymptomProcedures
Concept Acute myeloid leukaemia refractory IntendedEffects
Concept therapeutic
Entry 21 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10059034
Resso}:
Profile: ClinicalUseDefinition Indication
type: Indication
indication
DiseaseSymptomProcedures
Concept Acute myeloid leukaemia recurrent IntendedEffects
Concept therapeutic
Entry 22 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10060558
Resso}:
Profile: ClinicalUseDefinition Indication
type: Indication
indication
DiseaseSymptomProcedures
Concept Acute myeloid leukemia recurrent IntendedEffects
Concept therapeutic
Entry 23 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10084619
Resso}:
Profile: ClinicalUseDefinition Indication
type: Indication
indication
DiseaseSymptomProcedures
Concept FLT3-Gen-Mutation IntendedEffects
Concept therapeutic