COTELLIC

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

Active ingredients

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

1	Cobimetinib UNII 6EXI96H8SV - COBIMETINIB FUMARATE
	Cobimetinib is a reversible, selective, allosteric, oral inhibitor that blocks the mitogen-activated protein kinase (MAPK) pathway by targeting the mitogen-activated extracellular signal-regulated kinase (MEK) 1 and MEK 2 which results in inhibition of phosphorylation of the extracellular signal-regulated kinase (ERK) 1 and ERK 2. Therefore, cobimetinib blocks the cell proliferation induced by the MAPK pathway through inhibition of the MEK1/2 signalling node.
	Read more about Cobimetinib

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
COTELLIC Film-coated tablet	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
L01EE02		L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EE Mitogen-activated protein kinase (MEK) inhibitors
Discover more medicines within L01EE02

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	11074W, 11075X
BR	Câmara de Regulação do Mercado de Medicamentos	529216110026801
CA	Health Products and Food Branch	02452340
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	4323-MEE-0818
EE	Ravimiamet	1706004
ES	Centro de información online de medicamentos de la AEMPS	1151048001
FR	Base de données publique des médicaments	65045274
GB	Medicines & Healthcare Products Regulatory Agency	312571
HK	Department of Health Drug Office	64797
IE	Health Products Regulatory Authority	88885
IL	מִשְׂרַד הַבְּרִיאוּת	7804
LT	Valstybinė vaistų kontrolės tarnyba	1078869
NL	Z-Index G-Standaard, PRK	130478
NZ	Medicines and Medical Devices Safety Authority	18222
PL	Rejestru Produktów Leczniczych	100358201
SG	Health Sciences Authority	15219P
TR	İlaç ve Tıbbi Cihaz Kurumu	8699505092645
US	FDA, National Drug Code	50242-717