Binimetinib

Mektovi 45 MG Comprimidos Recubiertos con Pelicula

45 mg comprimido recubierto con películaSpainMarketedAuthorised 8 Oct 2024

Product informationAsk Osler about it

In other countries

The same active substances on other registers, the same brand first.

Authorised centrally in the EU

This national listing belongs to a medicine the European Commission authorised for the whole EU.

MektoviEuropean UnionAuthorised

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

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Binimetinib

Mektovi 45 MG Comprimidos Recubiertos con Pelicula

45 mg comprimido recubierto con películaSpainMarketedAuthorised 8 Oct 2024

Product informationAsk Osler about it

In other countries

The same active substances on other registers, the same brand first.

Authorised centrally in the EU

This national listing belongs to a medicine the European Commission authorised for the whole EU.

MektoviEuropean UnionAuthorised

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Discover Osler

Mektovi 15 mg, filmomhulde tablettenNetherlands · Filmomhulde tablet · Pierre Fabre Medicament

Mektovi 45 mg, filmomhulde tablettenNetherlands · Filmomhulde tablet · Pierre Fabre Medicament

MektoviSaudi Arabia · Almac Pharma Services Limited

Mektovi Film-Coated Tablet 15MGSingapore · 15mg · tablet, film coated · Pierre Fabre Singapore Pte. LTD.

MektoviUnited States · 15MG · tablet · Array Biopharma INC

BinimetinibUnited States · 15MG · tablet · Teva Pharmaceuticals USA, INC.

BinimetinibUnited States · 15MG · tablet · Alembic Pharms LTD

BalimekEuropean Union · Pierre Fabre Médicament

Packs

Pack	Code	Status
MEKTOVI 45 MG COMPRIMIDOS RECUBIERTOS CON PELICULA, 28 comprimidos	765928

Documents

The official texts, at the regulator.

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

Agencia Española de Medicamentos y Productos Sanitarios

Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA medicamentos, acquired 11 October 2026 UTC; each source response/update date retained.

Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required · Added 12 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substance: Binimetinib
Strength: 45 mg
Dosage form: comprimido recubierto con película
Route: vía oral
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 8 Oct 2024
Registration: 1181315003
Marketing authorisation holder: Pierre Fabre Medicament
Procedure: EU centralised
Supply: Diagnóstico Hospitalario
EU number: EU/1/18/1315

Spain