This medicine is authorised for use in the European Union.


Mekinist is a cancer medicine used to treat adults whose cancer cells have a specific genetic mutation (change) in their genes called 'BRAF V600'. It is used for the treatment of:

  • melanoma (a skin cancer) that has spread or cannot be removed surgically. Mekinist is used on its own or in combination with another cancer medicine, dabrafenib;
  • advanced (stage III) melanoma after surgery for it. Mekinist is used in combination with dabrafenib;
  • advanced non-small cell lung cancer. It is used in combination with dabrafenib.

Mekinist contains the active substance trametinib.

This EPAR was last updated on 27/02/2023

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Vista Building
Elm Park
Merrion Road
Dublin 4

Product information

24/02/2023 Mekinist - EMEA/H/C/002643 - IAIN/0058

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication


Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).

Trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy (see section 5.1).

Adjuvant treatment of melanoma

Trametinib in combination with dabrafenib is indicated for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection.

Non-small cell lung cancer (NSCLC)

Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation.

Assessment history

Changes since initial authorisation of medicine

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