Mekinist

RSS

trametinib

Authorised
This medicine is authorised for use in the European Union.

Overview

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 07/09/2018

Authorisation details

Product details
Name
Mekinist
Agency product number
EMEA/H/C/002643
Active substance
trametinib
International non-proprietary name (INN) or common name
trametinib
Therapeutic area (MeSH)
Melanoma
Anatomical therapeutic chemical (ATC) code
L01XE25
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
30/06/2014
Contact address
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

27/08/2018 Mekinist - EMEA/H/C/002643 - WS/1274

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

ANTINEOPLASTIC AGENTS

Therapeutic indication

Melanoma

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.

Trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy.

Adjuvant treatment of melanoma

Dabrafenib in combination with trametinib 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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