Mektovi

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binimetinib

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

Overview

Mektovi is a medicine for treating melanoma (a skin cancer) that has spread or cannot be removed by surgery.

Mektovi is used in combination with another medicine, encorafenib (Braftovi), and is only for patients whose cancer cells have a specific mutation (change) in their genes called 'BRAF V600'.

It contains the active substance binimetinib.

This EPAR was last updated on 12/10/2018

Authorisation details

Product details
Name
Mektovi
Agency product number
EMEA/H/C/004579
Active substance
binimetinib
International non-proprietary name (INN) or common name
binimetinib
Therapeutic area (MeSH)
Melanoma
Anatomical therapeutic chemical (ATC) code
L01XE
Additional 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
Pierre Fabre Medicament
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
20/09/2018
Contact address

45 Place Abel Gance
92100 Boulogne-Billancourt
France

Product information

26/07/2018 Mektovi - EMEA/H/C/004579 -

Contents

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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

Assessment history

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