MEKTOVI Film-coated tablet Ref.[8686] Active ingredients: Binimetinib

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Pierre Fabre Mรฉdicament, 45, place Abel Gance, 92100, Boulogne-Billancourt, France

Product name and form

Mektovi 15 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Yellow to dark yellow, unscored biconvex, ovaloid film-coated tablets approximately 12 mm in length and 5 mm in width, with the “A” logo debossed on one side of the tablet and “15” on the other side.

Qualitative and quantitative composition

Each film-coated tablet contains 15 mg of binimetinib.

Excipient with known effect: Each film-coated tablet contains 133.5 mg of lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Binimetinib

Binimetinib is an ATP-uncompetitive, reversible inhibitor of the kinase activity of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2. Binimetinib inhibits activation of MEK by BRAF and inhibits MEK kinase activity. Binimetinib inhibits growth of BRAF V600 mutant melanoma cell lines.

List of Excipients

Tablet core:

Lactose monohydrate
Cellulose microcrystalline (E460i)
Silica colloidal anhydrous (E551)
Croscarmellose sodium (E468)
Magnesium stearate (E470b)

Film-coating:

Polyvinyl alcohol (E1203)
Macrogol 3350 (E1521)
Titanium dioxide (E171)
Talc (E533b)
Iron oxide yellow (E172)
Iron oxide black (E172)

Pack sizes and marketing

PVC/PVDC/Alu blister containing 12 tablets. Each pack contains either 84 or 168 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Pierre Fabre Mรฉdicament, 45, place Abel Gance, 92100, Boulogne-Billancourt, France

Marketing authorization dates and numbers

EU/1/18/1315/001 84 film-coated tablets
EU/1/18/1315/002 168 film-coated tablets

Date of first authorisation: 20 September 2018

Drugs

Drug Countries
MEKTOVI Austria, Australia, Estonia, Spain, Finland, France, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States

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