Cotellic

RSS

cobimetinib

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

Overview

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.

This EPAR was last updated on 31/08/2018

Authorisation details

Product details
Name
Cotellic
Agency product number
EMEA/H/C/003960
Active substance
cobimetinib hemifumarate
International non-proprietary name (INN) or common name
cobimetinib
Therapeutic area (MeSH)
Melanoma
Anatomical therapeutic chemical (ATC) code
L01XE38
Additional monitoringAdditional 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
Roche Registration GmbH
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
20/11/2015
Contact address
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Product information

09/08/2018 Cotellic - EMEA/H/C/003960 - N/0013

Contents

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

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.

Assessment history

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