ODOMZO

This brand name is authorized in United States. It is also authorized in Australia, Austria, Canada, Croatia, Estonia, Finland, France, Ireland, Israel, Italy, Lithuania, New Zealand, Poland, Spain.

Active ingredients

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

1	Sonidegib UNII W421AI34UW - SONIDEGIB PHOSPHATE
	Sonidegib is an orally bioavailable inhibitor of the Hh signalling pathway. It binds to Smoothened (Smo), a G protein-coupled receptor-like molecule that positively regulates the Hh pathway. Aberrant Hh signalling has been linked to the pathogenesis of several types of cancer, including basal cell carcinoma (BCC). Sonidegib binding to Smo will inhibit Hh signalling and consequently block signal transduction.
	Read more about Sonidegib

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
ODOMZO Hard capsule	MPI, EU: SmPC	European Medicines Agency (EU)

Medicine classification

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

ATC Group		Classification
L01XJ02		L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01X Other antineoplastic agents → L01XJ Hedgehog pathway inhibitors
Discover more medicines within L01XJ02

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
AU	Pharmaceutical Benefits Scheme	11304Y
CA	Health Products and Food Branch	02500337
EE	Ravimiamet	1695179, 1695180
ES	Centro de información online de medicamentos de la AEMPS	1151030002
FI	Lääkealan turvallisuus- ja kehittämiskeskus	401494
FR	Base de données publique des médicaments	65006905
IL	מִשְׂרַד הַבְּרִיאוּת	7835
IT	Agenzia del Farmaco	044480010, 044480022
LT	Valstybinė vaistų kontrolės tarnyba	1077881, 1077884
NZ	Medicines and Medical Devices Safety Authority	19858
PL	Rejestru Produktów Leczniczych	100354002
US	FDA, National Drug Code	47335-303