Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: PIERRE FABRE MEDICAMENT, Les Cauquillous, 81500 Lavaur, France
Mektovi 15 mg film-coated tablets.
Mektovi 45 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Mektovi 15 mg film-coated tablets: 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. Mektovi 45 mg film-coated tablets: White to off-white, unscored biconvex, ovaloid film-coated tablets approximately 15 mm in length and 6 mm in width, with “45” debossed on one side. |
Each film-coated tablet contains 15 mg of binimetinib.
Excipient with known effect: Each film-coated tablet contains 133.5 mg of lactose monohydrate.
Each film-coated tablet contains 45 mg of binimetinib.
Excipient with known effect: Each film-coated tablet contains 234.9 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. MEK proteins are upstream regulators of the extracellular signal-related kinase (ERK) pathway, which promotes cellular proliferation. Binimetinib inhibits activation of MEK by BRAF and inhibits MEK kinase activity. |
| List of Excipients |
|---|
|
Tablet core: Lactose monohydrate Film-coating: Mektovi 15 mg film-coated tablets Poly(vinyl alcohol) (E1203) Mektovi 45 mg film-coated tablets Poly(vinyl alcohol) (E1203) |
Mektovi 15 mg film-coated tablets:
PVC/PVDC/Alu blister containing 12 tablets. Each pack contains either 84 or 168 tablets.
Not all pack sizes may be marketed.
Mektovi 45 mg film-coated tablets:
PVC/PVDC/Alu blister containing 14 tablets. Each pack contains either 28 or 56 tablets.
Not all pack sizes may be marketed.
PIERRE FABRE MEDICAMENT, Les Cauquillous, 81500 Lavaur, France
EU/1/18/1315/001 84 film-coated tablets
EU/1/18/1315/002 168 film-coated tablets
EU/1/18/1315/003 28 film-coated tablets
EU/1/18/1315/004 56 film-coated tablets
Date of first authorisation: 20 September 2018
Date of latest renewal: 23 June 2023
| Drug | Countries | |
|---|---|---|
| MEKTOVI | Austria, Australia, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States |
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