ERIVEDGE

This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Romania, South Africa, Spain, Turkey, UK.

Active ingredients

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

1	Vismodegib UNII 25X868M3DS - VISMODEGIB
	Vismodegib is an orally available small-molecule inhibitor of the Hedgehog pathway. Hedgehog pathway signalling through the Smoothened transmembrane protein (SMO) leads to the activation and nuclear localisation of Glioma-Associated Oncogene (GLI) transcription factors and induction of Hedgehog target genes. Vismodegib binds to and inhibits the SMO protein thereby blocking Hedgehog signal transduction.
	Read more about Vismodegib

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
ERIVEDGE 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
L01XJ01		L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01X Other antineoplastic agents → L01XJ Hedgehog pathway inhibitors
Discover more medicines within L01XJ01

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	11070P
BR	Câmara de Regulação do Mercado de Medicamentos	529217010026901
CA	Health Products and Food Branch	02409267
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	365460513
EE	Ravimiamet	1621505
ES	Centro de información online de medicamentos de la AEMPS	113848001
FI	Lääkealan turvallisuus- ja kehittämiskeskus	376974
FR	Base de données publique des médicaments	67507605
GB	Medicines & Healthcare Products Regulatory Agency	227643
HK	Department of Health Drug Office	63786
IE	Health Products Regulatory Authority	88868
IL	מִשְׂרַד הַבְּרִיאוּת	7166
LT	Valstybinė vaistų kontrolės tarnyba	1070868
NL	Z-Index G-Standaard, PRK	106585
NZ	Medicines and Medical Devices Safety Authority	15947
PL	Rejestru Produktów Leczniczych	100299668
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W64376001
TR	İlaç ve Tıbbi Cihaz Kurumu	8699505152066
US	FDA, National Drug Code	50242-140
ZA	Health Products Regulatory Authority	48/32.16/0658