Basic Information
Tafinlar
Regulatory Information
EMEA/H/C/002604
August 26, 2013
June 27, 2013
35
December 5, 2024
Company Information
Ireland
Vista Building Elm Park Merrion Road Dublin 4
NOVARTIS EUROPHARM LIMITED
Active Substances Detail
dabrafenib mesilate
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication **Melanoma** 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.
Overview Summary
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.