DAURISMO

This brand name is authorized in Austria, Canada, Estonia, Finland, Croatia, Ireland, Lithuania, Poland, Romania, United Kingdom, United States

Active ingredients

The drug DAURISMO contains one active pharmaceutical ingredient (API):

1 Glasdegib
UNII TH2EV99S4Z - GLASDEGIB MALEATE

Glasdegib is an inhibitor of the Hedgehog (Hh) signal transduction pathway that binds to Smoothened (SMO), a transmembrane protein, leading to decreased Glioma-Associated Oncogene (GLI) transcription factor activity and downstream pathway signalling. Hh pathway signalling is required for maintaining a leukaemic stem cell (LSC) population thus, glasdegib binding to and inhibiting SMO reduces GLI1 levels in AML cells and the leukaemic initiating potential of AML cells.

Read about Glasdegib

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
DAURISMO Film-coated tablet European Medicines Agency (EU) MPI, EU: SmPC
DAURISMO Film-coated tablet FDA, National Drug Code (US) MPI, US: SPL/PLR

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code Group title Classification
L01XJ03 L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01X Other antineoplastic agents → L01XJ Hedgehog pathway inhibitors
Discover more medicines within L01XJ03

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
Country: CA Health Products and Food Branch Identifier(s): 02498472, 02498480
Country: EE Ravimiamet Identifier(s): 1821956, 1821967
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 140223, 512958
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 386990, 386995
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1090735, 1090736, 1090737, 1090738
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100439187, 100439193
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W67083001, W67083002, W67085001, W67085002
Country: US FDA, National Drug Code Identifier(s): 0069-0298, 0069-1531

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