Generated Narrative: MedicinalProductDefinition Xospata-Filmcoatedtablet

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

-CountryStatusDateRange
*SwitzerlandNo interruption of distribution reported2020-09-24 --> (ongoing)

attachedDocument:

name

productName: Xospata 40 mg, Filmtabletten

Usages

-CountryLanguage
*SwitzerlandGerman (Switzerland)

Generated Narrative: DocumentReference DocRef-FI-Xospata

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

Generated Narrative: DocumentReference DocRef-PI-Xospata

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

-LanguageUrl
*German (Switzerland)https://Swissmedicinfo.ch/showText.aspx?textType=PI&lang=DE&authNr=67211&supportMultipleResults=1

Generated Narrative: RegulatedAuthorization MA-6721101

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

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')

Generated Narrative: RegulatedAuthorization MA-67211001

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

status: Active

manufacturedDoseForm: Film-coated tablet

unitOfPresentation: Tablet

Generated Narrative: AdministrableProductDefinition PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet

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:

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 HydroxypropylcellulosumSubstitutumHumile

Profile: Ingredient

status: Active

for:

role: Excipient

substance

Codes

-Concept
*Hydroxypropylcellulose, low-substituted

Generated Narrative: ClinicalUseDefinition IND-10081514

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

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

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

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

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