Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
Cotellic 20 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. White, round film-coated tablets of approximately 6.6 mm diameter, with “COB” debossed on one side. |
Each film-coated tablet contains cobimetinib hemifumarate equivalent to 20 mg cobimetinib.
Excipient with known effect: Each film-coated tablet contains 36 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Cobimetinib |
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. |
| List of Excipients |
|---|
|
Tablet core: Lactose monohydrate Film coating: Polyvinyl alcohol |
Transparent PVC/PVDC blisters containing 21 tablets.
Each pack contains 63 tablets.
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
EU/1/15/1048/001
20 November 2015
| Drug | Countries | |
|---|---|---|
| COTELLIC | 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 |
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