Mektovi
binimetinib
Table of contents
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.
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Mektovi : EPAR - Medicine overview (PDF/74.06 KB)
First published: 12/10/2018
EMA/570416/2018 -
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Mektovi : EPAR - Risk-management plan summary (PDF/112.85 KB)
First published: 12/10/2018
Last updated: 13/07/2020
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 |
L01EE03
|
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 | |
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Marketing-authorisation holder |
Pierre Fabre Medicament
|
Revision |
7
|
Date of issue of marketing authorisation valid throughout the European Union |
20/09/2018
|
Contact address |
Pierre Fabre Medicament |
Product information
23/06/2023 Mektovi - EMEA/H/C/004579 - R/0024
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.