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