COTELLIC Film-coated tablet Ref.[7186] Active ingredients: Cobimetinib

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany

Product name and form

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.

Qualitative and quantitative composition

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
Microcrystalline cellulose (E460)
Croscarmellose sodium (E468)
Magnesium stearate (E470b)

Film coating:

Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol 3350
Talc (E553b)

Pack sizes and marketing

Transparent PVC/PVDC blisters containing 21 tablets.

Each pack contains 63 tablets.

Marketing authorization holder

Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany

Marketing authorization dates and numbers

EU/1/15/1048/001

20 November 2015

Drugs

Drug Countries
COTELLIC Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, France, Hong Kong, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Singapore, Turkey, United Kingdom, United States

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