http://fhir.ch/ig/ch-idmp/Bundle/ab55cf13-a819-4875-adaa-5545e2cbdddf
type: Bundle
node role: treeRoot
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-bundle
    l: ch-idmp-bundle
language:
  v: de-CH
type:
  v: collection
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/MedicinalProductDefinition/Xospata-Filmcoatedtablet
    l: Xospata-Filmcoatedtablet
  resource: Xospata-Filmcoatedtablet
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/DocumentReference/DocRef-FI-Xospata
    l: DocRef-FI-Xospata
  resource: DocRef-FI-Xospata
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/DocumentReference/DocRef-PI-Xospata
    l: DocRef-PI-Xospata
  resource: DocRef-PI-Xospata
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/RegulatedAuthorisation/MA-6721101
    l: MA-6721101
  resource: MA-6721101
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/PackagedProductDefinition/PMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
    l: PMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
  resource: PMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/RegulatedAuthorisation/MA-67211001
    l: MA-67211001
  resource: MA-67211001
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
    l: MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
  resource: MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
    l: PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
  resource: PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/Ingredient/GilteritinibiHemifumaras40
    l: GilteritinibiHemifumaras40
  resource: GilteritinibiHemifumaras40
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/Ingredient/Mannitolum
    l: Mannitolum
  resource: Mannitolum
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/Ingredient/Hydroxypropylcellulosum
    l: Hydroxypropylcellulosum
  resource: Hydroxypropylcellulosum
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/Ingredient/HydroxypropylcellulosumSubstitutumHumile
    l: HydroxypropylcellulosumSubstitutumHumile
  resource: HydroxypropylcellulosumSubstitutumHumile
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/Ingredient/Talcum
    l: Talcum
  resource: Talcum
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/Ingredient/Macrogolum8000
    l: Macrogolum8000
  resource: Macrogolum8000
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/Ingredient/E171
    l: E171
  resource: E171
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/Ingredient/E172Flavum
    l: E172Flavum
  resource: E172Flavum
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/Ingredient/MagnesiumStearate
    l: MagnesiumStearate
  resource: MagnesiumStearate
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/Ingredient/Hypromellosum
    l: Hypromellosum
  resource: Hypromellosum
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10081514
    l: IND-10081514
  resource: IND-10081514
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10081513
    l: IND-10081513
  resource: IND-10081513
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10059034
    l: IND-10059034
  resource: IND-10059034
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10060558
    l: IND-10060558
  resource: IND-10060558
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10084619
    l: IND-10084619
  resource: IND-10084619

Xospata-Filmcoatedtablet
type: MedicinalProductDefinition
id:
  v: Xospata-Filmcoatedtablet
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-medicinalproductdefinition
    l: ch-idmp-medicinalproductdefinition
text:
  status:
    v: extensions
  div:
    v: Generated Narrative: MedicinalProductDefinition Xospata-Filmcoatedtablet 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)
extension:
  url:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/authorizedDoseForm
    l: authorizedDoseForm
  value: CodeableConcept
    coding:
      system:
        v: http://standardterms.edqm.eu
        l: standardterms.edqm.eu
      code:
        v: 10221000
      display:
        v: Film-coated tablet
identifier:
  system:
    v: http://fhir.ch/ig/ch-idmp/sid/mpid
    l: mpid
  value:
    v: CH-01100869-0672110010000
indication:
  v: 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.
legal status of supply:
  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
additional monitoring indicator:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-additional-monitoring-indicator
      l: ch-SMC-additional-monitoring-indicator
    code:
      v: 756005001003
    display:
      v: No Warning
pediatric use indicator:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-pediatric-use-indicator
      l: ch-SMC-pediatric-use-indicator
    code:
      v: 756005003002
    display:
      v: Not authorised for the treatment in children
classification:
  coding:
    system:
      v: http://www.whocc.no/atc
      l: atc
    code:
      v: L01EX13
classification:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-MedicinalProductCategory
      l: ch-SMC-MedicinalProductCategory
    code:
      v: 756005039000001
    display:
      v: Synthetic
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-SMC-marketing-status
        l: ch-SMC-marketing-status
      code:
        v: 7560050074000003
      display:
        v: No interruption of distribution reported
  date range:
    start:
      v: 2020-09-24
attached document:
  l: DocRef-FI-Xospata
  reference:
    v: DocumentReference/DocRef-FI-Xospata
attached document:
  l: DocRef-PI-Xospata
  reference:
    v: DocumentReference/DocRef-PI-Xospata
name:
  product name:
    v: Xospata 40 mg, Filmtabletten

DocRef-FI-Xospata
type: DocumentReference
id:
  v: DocRef-FI-Xospata
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-documentreference
    l: ch-idmp-documentreference
text:
  status:
    v: generated
  div:
    v: Generated Narrative: DocumentReference DocRef-FI-Xospata 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
identifier:
  system:
    v: http://fhir.ch/ig/ch-idmp/sid/attno
    l: attno
  value:
    v: 123456989-initial submission-Example-xyz-123
status:
  v: current
type:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-attached-document-type
      l: ch-SMC-attached-document-type
    code:
      v: 756005040000001
    display:
      v: Information for healthcare professionals
date:
  v: 2021-11-09T00:00:00Z
content:
  attachment:
    url:
      v: https://Swissmedicinfo.ch/showText.aspx
      l: https://Swissmedicinfo.ch/showText.aspx

DocRef-PI-Xospata
type: DocumentReference
id:
  v: DocRef-PI-Xospata
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-documentreference
    l: ch-idmp-documentreference
text:
  status:
    v: generated
  div:
    v: Generated Narrative: DocumentReference DocRef-PI-Xospata 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 * German (Switzerland) https://Swissmedicinfo.ch/showText.aspx?textType=PI&lang=DE&authNr=67211&supportMultipleResults=1
identifier:
  system:
    v: http://fhir.ch/ig/ch-idmp/sid/attno
    l: attno
  value:
    v: 123456989-initial submission-Example-abc-123
status:
  v: current
type:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-attached-document-type
      l: ch-SMC-attached-document-type
    code:
      v: 756005040000002
    display:
      v: Patient Information
date:
  v: 2021-11-09T00:00:00Z
content:
  attachment:
    language:
      v: de-CH
    url:
      v: https://Swissmedicinfo.ch/showText.aspx
      l: https://Swissmedicinfo.ch/showText.aspx

MA-6721101
type: RegulatedAuthorization
id:
  v: MA-6721101
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-regulatedauthorization
    l: ch-idmp-regulatedauthorization
text:
  status:
    v: generated
  div:
    v: Generated Narrative: RegulatedAuthorization MA-6721101 Profile: RegulatedAuthorization identifier: Marketing Authorisation Number/6721101 subject: 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 type: Marketing Authorisation region: Switzerland status: approved statusDate: 2021-11-09 validityPeriod: 2021-11-09 --> (ongoing) holder: Organization Astellas Pharma AG regulator: Organization SMC Generated Narrative: Organization #holder-Astellas-Pharma-AG Profile: Organization identifier: Swissmedic Location Identifier/01100869, LOC Identifier/100010745, GLN Identifier/7601001000964 name: Astellas Pharma AG Generated Narrative: Organization #regulator-SMC Profile: Organization identifier: LOC Identifier/100010911, GLN Identifier/7601001398511 name: SMC
contained: Organization
  id:
    v: holder-Astellas-Pharma-AG
  meta:
    profile:
      v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization
      l: ch-idmp-organization
  identifier:
    system:
      v: https://www.swissmedic.ch/fhir/identifier/locations
      l: locations
    value:
      v: 01100869
  identifier:
    system:
      v: https://spor.ema.europa.eu/v1/locations
      l: locations
    value:
      v: 100010745
  identifier:
    system:
      v: urn:oid:2.51.1.3
      l: 2.51.1.3
    value:
      v: 7601001000964
  name:
    v: Astellas Pharma AG
contained: Organization
  id:
    v: regulator-SMC
  meta:
    profile:
      v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization
      l: ch-idmp-organization
  identifier:
    system:
      v: https://spor.ema.europa.eu/v1/locations
      l: locations
    value:
      v: 100010911
  identifier:
    system:
      v: urn:oid:2.51.1.3
      l: 2.51.1.3
    value:
      v: 7601001398511
  name:
    v: SMC
identifier:
  system:
    v: http://fhir.ch/ig/ch-idmp/sid/authno
    l: authno
  value:
    v: 6721101
subject:
  l: Xospata-Filmcoatedtablet
  reference:
    v: MedicinalProductDefinition/Xospata-Filmcoatedtablet
type:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-authorisation-type-cs
      l: ch-authorisation-type-cs
    code:
      v: 756000002001
    display:
      v: Marketing Authorisation
region:
  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-SMC-authorisation-status
      l: ch-SMC-authorisation-status
    code:
      v: 756005010000001
    display:
      v: approved
status date:
  v: 2021-11-09
validity period:
  start:
    v: 2021-11-09
holder:
  l: holder-Astellas-Pharma-AG
  reference:
    v: #holder-Astellas-Pharma-AG
regulator:
  l: regulator-SMC
  reference:
    v: #regulator-SMC

PMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
type: PackagedProductDefinition
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

MA-67211001
type: RegulatedAuthorization
id:
  v: MA-67211001
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-regulatedauthorization
    l: ch-idmp-regulatedauthorization
text:
  status:
    v: generated
  div:
    v: Generated Narrative: RegulatedAuthorization MA-67211001 Profile: RegulatedAuthorization identifier: Marketing Authorisation Number/67211001 subject: PackagedProductDefinition: identifier = http://fhir.ch/ig/ch-idmp/sid/pcid#Clinical Product Identifier#CH-01100869-0672110010000-0001; containedItemQuantity = 48 Tablet; description = 4 Blister zu 7 Tabletten in 1 Box type: Marketing Authorisation region: Switzerland status: approved statusDate: 2021-11-09 validityPeriod: 2021-11-09 --> (ongoing) holder: Organization Astellas Pharma AG regulator: Organization SMC Generated Narrative: Organization #holder-Astellas-Pharma-AG Profile: Organization identifier: Swissmedic Location Identifier/01100869, LOC Identifier/100010745, GLN Identifier/7601001000964 name: Astellas Pharma AG Generated Narrative: Organization #regulator-SMC Profile: Organization identifier: LOC Identifier/100010911, GLN Identifier/7601001398511 name: SMC
contained: Organization
  id:
    v: holder-Astellas-Pharma-AG
  meta:
    profile:
      v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization
      l: ch-idmp-organization
  identifier:
    system:
      v: https://www.swissmedic.ch/fhir/identifier/locations
      l: locations
    value:
      v: 01100869
  identifier:
    system:
      v: https://spor.ema.europa.eu/v1/locations
      l: locations
    value:
      v: 100010745
  identifier:
    system:
      v: urn:oid:2.51.1.3
      l: 2.51.1.3
    value:
      v: 7601001000964
  name:
    v: Astellas Pharma AG
contained: Organization
  id:
    v: regulator-SMC
  meta:
    profile:
      v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization
      l: ch-idmp-organization
  identifier:
    system:
      v: https://spor.ema.europa.eu/v1/locations
      l: locations
    value:
      v: 100010911
  identifier:
    system:
      v: urn:oid:2.51.1.3
      l: 2.51.1.3
    value:
      v: 7601001398511
  name:
    v: SMC
identifier:
  system:
    v: http://fhir.ch/ig/ch-idmp/sid/authno
    l: authno
  value:
    v: 67211001
subject:
  l: PMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
  reference:
    v: PackagedProductDefinition/PMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
type:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-authorisation-type-cs
      l: ch-authorisation-type-cs
    code:
      v: 756000002001
    display:
      v: Marketing Authorisation
region:
  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-SMC-authorisation-status
      l: ch-SMC-authorisation-status
    code:
      v: 756005010000001
    display:
      v: approved
status date:
  v: 2021-11-09
validity period:
  start:
    v: 2021-11-09
holder:
  l: holder-Astellas-Pharma-AG
  reference:
    v: #holder-Astellas-Pharma-AG
regulator:
  l: regulator-SMC
  reference:
    v: #regulator-SMC

MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
type: ManufacturedItemDefinition
id:
  v: MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-manufactureditemdefinition
    l: ch-idmp-manufactureditemdefinition
text:
  status:
    v: generated
  div:
    v: Generated Narrative: ManufacturedItemDefinition MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet Profile: ManufacturedItemDefinition status: Active manufacturedDoseForm: Film-coated tablet unitOfPresentation: Tablet
status:
  v: active
manufactured dose form:
  coding:
    system:
      v: http://standardterms.edqm.eu
      l: standardterms.edqm.eu
    code:
      v: 10221000
    display:
      v: Film-coated tablet
unit of presentation:
  coding:
    system:
      v: http://standardterms.edqm.eu
      l: standardterms.edqm.eu
    code:
      v: 15054000
    display:
      v: Tablet

PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
type: AdministrableProductDefinition
id:
  v: PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-administrableproductdefinition
    l: ch-idmp-administrableproductdefinition
text:
  status:
    v: generated
  div:
    v: Generated Narrative: AdministrableProductDefinition PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet Profile: AdministrableProductDefinition status: Active formOf: 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 administrableDoseForm: Film-coated tablet unitOfPresentation: Tablet RouteOfAdministrations - Code * Oral use
status:
  v: active
form of:
  l: Xospata-Filmcoatedtablet
  reference:
    v: MedicinalProductDefinition/Xospata-Filmcoatedtablet
administrable dose form:
  coding:
    system:
      v: http://standardterms.edqm.eu
      l: standardterms.edqm.eu
    code:
      v: 10221000
    display:
      v: Film-coated tablet
unit of presentation:
  coding:
    system:
      v: http://standardterms.edqm.eu
      l: standardterms.edqm.eu
    code:
      v: 15054000
    display:
      v: Tablet
route of administration:
  code:
    coding:
      system:
        v: http://standardterms.edqm.eu
        l: standardterms.edqm.eu
      code:
        v: 20053000
      display:
        v: Oral use

GilteritinibiHemifumaras40
type: Ingredient
id:
  v: GilteritinibiHemifumaras40
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient
    l: ch-idmp-ingredient
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient GilteritinibiHemifumaras40 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')
status:
  v: active
for:
  l: PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
  reference:
    v: AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
for:
  l: MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
  reference:
    v: ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
role:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role
      l: ch-SMC-ingredient-role
    code:
      v: 756005035000001
    display:
      v: Active
substance:
  strength:
    presentation: Ratio
    reference strength:
      strength: Ratio

Mannitolum
type: Ingredient
id:
  v: Mannitolum
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient
    l: ch-idmp-ingredient
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient Mannitolum 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
status:
  v: active
for:
  l: PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
  reference:
    v: AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
for:
  l: MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
  reference:
    v: ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
role:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role
      l: ch-SMC-ingredient-role
    code:
      v: 756005035000002
    display:
      v: Excipient

Hydroxypropylcellulosum
type: Ingredient
id:
  v: Hydroxypropylcellulosum
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient
    l: ch-idmp-ingredient
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient Hydroxypropylcellulosum 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
status:
  v: active
for:
  l: PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
  reference:
    v: AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
for:
  l: MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
  reference:
    v: ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
role:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role
      l: ch-SMC-ingredient-role
    code:
      v: 756005035000002
    display:
      v: Excipient

HydroxypropylcellulosumSubstitutumHumile
type: Ingredient
id:
  v: HydroxypropylcellulosumSubstitutumHumile
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient
    l: ch-idmp-ingredient
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient HydroxypropylcellulosumSubstitutumHumile 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
status:
  v: active
for:
  l: PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
  reference:
    v: AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
for:
  l: MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
  reference:
    v: ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
role:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role
      l: ch-SMC-ingredient-role
    code:
      v: 756005035000002
    display:
      v: Excipient

Talcum
type: Ingredient
id:
  v: Talcum
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient
    l: ch-idmp-ingredient
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient Talcum 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
status:
  v: active
for:
  l: PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
  reference:
    v: AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
for:
  l: MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
  reference:
    v: ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
role:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role
      l: ch-SMC-ingredient-role
    code:
      v: 756005035000002
    display:
      v: Excipient

Macrogolum8000
type: Ingredient
id:
  v: Macrogolum8000
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient
    l: ch-idmp-ingredient
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient Macrogolum8000 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
status:
  v: active
for:
  l: PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
  reference:
    v: AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
for:
  l: MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
  reference:
    v: ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
role:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role
      l: ch-SMC-ingredient-role
    code:
      v: 756005035000002
    display:
      v: Excipient

E171
type: Ingredient
id:
  v: E171
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient
    l: ch-idmp-ingredient
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient E171 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
status:
  v: active
for:
  l: PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
  reference:
    v: AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
for:
  l: MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
  reference:
    v: ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
role:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role
      l: ch-SMC-ingredient-role
    code:
      v: 756005035000002
    display:
      v: Excipient

E172Flavum
type: Ingredient
id:
  v: E172Flavum
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient
    l: ch-idmp-ingredient
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient E172Flavum 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
status:
  v: active
for:
  l: PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
  reference:
    v: AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
for:
  l: MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
  reference:
    v: ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
role:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role
      l: ch-SMC-ingredient-role
    code:
      v: 756005035000002
    display:
      v: Excipient

MagnesiumStearate
type: Ingredient
id:
  v: MagnesiumStearate
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient
    l: ch-idmp-ingredient
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient MagnesiumStearate 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
status:
  v: active
for:
  l: PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
  reference:
    v: AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
for:
  l: MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
  reference:
    v: ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
role:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role
      l: ch-SMC-ingredient-role
    code:
      v: 756005035000002
    display:
      v: Excipient

Hypromellosum
type: Ingredient
id:
  v: Hypromellosum
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient
    l: ch-idmp-ingredient
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient Hypromellosum 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
status:
  v: active
for:
  l: PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
  reference:
    v: AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
for:
  l: MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
  reference:
    v: ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
role:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role
      l: ch-SMC-ingredient-role
    code:
      v: 756005035000002
    display:
      v: Excipient

IND-10081514
type: ClinicalUseDefinition
id:
  v: IND-10081514
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication
    l: ch-idmp-clinicalusedefinition-indication
text:
  status:
    v: generated
  div:
    v: Generated Narrative: ClinicalUseDefinition IND-10081514 Profile: ClinicalUseDefinition Indication type: Indication subject: 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 indication DiseaseSymptomProcedures - Concept * Acute myeloid leukemia refractory IntendedEffects - Concept * therapeutic
type:
  v: indication
subject:
  l: Xospata-Filmcoatedtablet
  reference:
    v: MedicinalProductDefinition/Xospata-Filmcoatedtablet

IND-10081513
type: ClinicalUseDefinition
id:
  v: IND-10081513
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication
    l: ch-idmp-clinicalusedefinition-indication
text:
  status:
    v: generated
  div:
    v: Generated Narrative: ClinicalUseDefinition IND-10081513 Profile: ClinicalUseDefinition Indication type: Indication subject: 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 indication DiseaseSymptomProcedures - Concept * Acute myeloid leukaemia refractory IntendedEffects - Concept * therapeutic
type:
  v: indication
subject:
  l: Xospata-Filmcoatedtablet
  reference:
    v: MedicinalProductDefinition/Xospata-Filmcoatedtablet

IND-10059034
type: ClinicalUseDefinition
id:
  v: IND-10059034
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication
    l: ch-idmp-clinicalusedefinition-indication
text:
  status:
    v: generated
  div:
    v: Generated Narrative: ClinicalUseDefinition IND-10059034 Profile: ClinicalUseDefinition Indication type: Indication subject: 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 indication DiseaseSymptomProcedures - Concept * Acute myeloid leukaemia recurrent IntendedEffects - Concept * therapeutic
type:
  v: indication
subject:
  l: Xospata-Filmcoatedtablet
  reference:
    v: MedicinalProductDefinition/Xospata-Filmcoatedtablet

IND-10060558
type: ClinicalUseDefinition
id:
  v: IND-10060558
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication
    l: ch-idmp-clinicalusedefinition-indication
text:
  status:
    v: generated
  div:
    v: Generated Narrative: ClinicalUseDefinition IND-10060558 Profile: ClinicalUseDefinition Indication type: Indication subject: 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 indication DiseaseSymptomProcedures - Concept * Acute myeloid leukemia recurrent IntendedEffects - Concept * therapeutic
type:
  v: indication
subject:
  l: Xospata-Filmcoatedtablet
  reference:
    v: MedicinalProductDefinition/Xospata-Filmcoatedtablet

IND-10084619
type: ClinicalUseDefinition
id:
  v: IND-10084619
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication
    l: ch-idmp-clinicalusedefinition-indication
text:
  status:
    v: generated
  div:
    v: Generated Narrative: ClinicalUseDefinition IND-10084619 Profile: ClinicalUseDefinition Indication type: Indication subject: 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 indication DiseaseSymptomProcedures - Concept * FLT3-Gen-Mutation IntendedEffects - Concept * therapeutic
type:
  v: indication
subject:
  l: Xospata-Filmcoatedtablet
  reference:
    v: MedicinalProductDefinition/Xospata-Filmcoatedtablet

v: urn:iso:std:iso:3166
l: 3166

v: CH

v: Switzerland

v: urn:ietf:bcp:47
l: 47

v: de-CH

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

v: 5RZZ0Z1GJT

v: Gilteritinib fumarate

v: 44.2

v: mg

v: mg

v: 1

v: tablet

v: 15054000

coding:
  system:
    v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance
    l: ch-SMC-substance
  code:
    v: 66D92MGC8M
  display:
    v: Gilteritinib

value:
  v: 40
unit:
  v: mg
system:
  v: http://unitsofmeasure.org
  l: unitsofmeasure.org
code:
  v: mg

value:
  v: 1
unit:
  v: tablet
system:
  v: http://standardterms.edqm.eu
  l: standardterms.edqm.eu
code:
  v: 15054000

v: 3OWL53L36A

v: Mannitol

v: 9XZ8H6N6OH

v: Hyprolose

v: 2165RE0K14

v: Hydroxypropylcellulose, low-substituted

v: 7SEV7J4R1U

v: Talc

v: Q662QK8M3B

v: Macrogol 8000

v: 15FIX9V2JP

v: Titanium dioxide

v: 15FIX9V2JP

v: Titanium dioxide

v: 70097M6I30

v: Magnesium stearate

v: 3NXW29V3WO

v: Hypromellose

v: 10081514

v: Acute myeloid leukemia refractory

v: 756005042000002

v: therapeutic

v: 10081513

v: Acute myeloid leukaemia refractory

v: 756005042000002

v: therapeutic

v: 10059034

v: Acute myeloid leukaemia recurrent

v: 756005042000002

v: therapeutic

v: 10060558

v: Acute myeloid leukemia recurrent

v: 756005042000002

v: therapeutic

v: 10084619

v: FLT3-Gen-Mutation

v: 756005042000002

v: therapeutic