Tafinlar is a cancer medicine used to treat adults whose cancer cells have a specific genetic mutation (change) called ‘BRAF V600’. It is used for the treatment of:
- melanoma (a skin cancer) that has spread or cannot be removed surgically. Tafinlar is used on its own or in combination with another cancer medicine, trametinib;
- advanced (stage III) melanoma after surgery for it. Tafinlar is used in combination with trametinib;
- advanced non-small cell lung cancer. It is used in combination with trametinib.
Tafinlar contains the active substance dabrafenib.
Tafinlar : EPAR - Medicine overview (PDF/82.66 KB)
First published: 18/09/2013
Last updated: 11/09/2018
Tafinlar : EPAR - Risk-management-plan summary (PDF/76.53 KB)
First published: 11/09/2018
Last updated: 19/04/2021
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Novartis Europharm Limited
|Date of issue of marketing authorisation valid throughout the European Union||
11/11/2021 Tafinlar - EMEA/H/C/002604 - WS2114
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.
Dabrafenib as monotherapy or in combination with trametinib 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).
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)
Dabrafenib in combination with trametinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 February 201724/02/2017