This is a summary of the European public assessment report (EPAR) for Cotellic. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Cotellic. For practical information about using Cotellic, patients should read the package leaflet or contact their doctor or pharmacist.
Therapeutic Indication
### Therapeutic indication Cotellic is indicated for use in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
Therapeutic Area (MeSH)
ATC Code
L01XE38
ATC Item
xl 01 xe 38
Pharmacotherapeutic Group
Antineoplastic agents
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| cobimetinib hemifumarate | N/A | cobimetinib hemifumarate |
EMA Name
Cotellic
Medicine Name
Cotellic
Aliases
N/A
