COTELLIC

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

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 about Cobimetinib

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
COTELLIC Film-coated tablet European Medicines Agency (EU) MPI, EU: SmPC

Medicine classification

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

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

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