Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Mekinist 0.5 mg film-coated tablets.
Mekinist 2 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Mekinist 0.5 mg film-coated tablets: Yellow, modified oval, biconvex, film-coated tablets, approximately 5.0 × 9.0 mm, with the company logo debossed on one face and “TT” on the opposing face. Mekinist 2 mg film-coated tablets: Pink, round, biconvex, film-coated tablets, approximately 7.6 mm, with the company logo debossed on one face and “LL” on the opposing face. |
Mekinist 0.5 mg film-coated tablets: Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 0.5 mg of trametinib.
Mekinist 2 mg film-coated tablets: Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 2 mg of trametinib.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Trametinib |
Trametinib is a reversible, highly selective, allosteric inhibitor of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2 activation and kinase activity. In melanoma and other cancers, this pathway is often activated by mutated forms of BRAF which activates MEK. Trametinib inhibits activation of MEK by BRAF and inhibits MEK kinase activity. |
| List of Excipients |
|---|
Mekinist 0.5 mg film-coated tabletsTablet core: Mannitol (E421) Tablet film coating: Hypromellose (E464) Mekinist 2 mg film-coated tabletsTablet core: Mannitol (E421) Tablet film coating: Hypromellose (E464) |
High-density polyethylene (HDPE) bottle with child-resistant polypropylene closure. The bottle contains a desiccant.
Pack sizes: One bottle contains either 7 or 30 tablets.
Not all pack sizes may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Mekinist 0.5 mg film-coated tablets:
EU/1/14/931/001
EU/1/14/931/002
Mekinist 2 mg film-coated tablets:
EU/1/14/931/005
EU/1/14/931/006
Date of first authorisation: 30 June 2014
Date of latest renewal: 14 February 2019
| Drug | Countries | |
|---|---|---|
| MEKINIST | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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