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)
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.
A: Single dispensing requiring a medical or veterinary prescription
Not authorised for the treatment in children
No interruption of distribution reported
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
123456989-initial submission-Example-xyz-123
Information for healthcare professionals
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
123456989-initial submission-Example-abc-123
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
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 quantity: 4 containedItem Items - Reference * ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet amount: 12 countable unit(s) (Details: UCUM code1 = '1')
Shelf life of the medicinal product as packaged for sale
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
Generated Narrative: ManufacturedItemDefinition MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet Profile: ManufacturedItemDefinition status: Active manufacturedDoseForm: Film-coated tablet unitOfPresentation: Tablet
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
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')
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
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
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
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
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
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
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
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
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
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
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
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
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
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