DAURISMO

This brand name is authorized in United States. It is also authorized in Austria, Canada, Croatia, Estonia, Finland, Ireland, Lithuania, Poland, Romania, UK.

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 more about Glasdegib

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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