Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 20 July 2018

Indication(s)

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.

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.

Full Prescribing information

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Chronic Obstructive Pulmonary Disease (COPD)

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More information

Category Value
Agency product number EMEA/H/C/002604
Orphan designation No
Date First Approved 26-08-2013
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Novartis Europharm Limited
Warnings

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reacti