MEKINIST Film-coated tablet Ref.[8867] Active ingredients: Trametinib

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Product name and form

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.

Qualitative and quantitative composition

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 tablets

Tablet core:

Mannitol (E421)
Microcrystalline cellulose (E460)
Hypromellose (E464)
Croscarmellose sodium (E468)
Magnesium stearate (E470b)
Sodium laurilsulfate
Colloidal silicon dioxide (E551)

Tablet film coating:

Hypromellose (E464)
Titanium dioxide (E171)
Polyethylene glycol
Iron oxide yellow (E172)

Mekinist 2 mg film-coated tablets

Tablet core:

Mannitol (E421)
Microcrystalline cellulose (E460)
Hypromellose (E464)
Croscarmellose sodium (E468)
Magnesium stearate (E470b)
Sodium laurilsulfate
Colloidal silicon dioxide(E551)

Tablet film coating:

Hypromellose (E464)
Titanium dioxide (E171)
Polyethylene glycol
Polysorbate 80 (E433)
Iron oxide red (E172)

Pack sizes and marketing

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.

Marketing authorization holder

Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Marketing authorization dates and numbers

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

Drugs

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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