Is Binimetinib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Binimetinib, including MEKTOVI (15 mg, Film-coated tablet, SAR 10134.65).

Is Binimetinib approved by the US FDA?

Drugs@FDA lists 1 application product line for Binimetinib, including MEKTOVI (Prescription).

Is Binimetinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Binimetinib: Mektovi.

Are there safety signals or safety updates for Binimetinib?

EMA PRAC: 4 entries; US FDA: 1 entry (latest 2026-04-10).

Active substance

Binimetinib

SFDA 1
US FDA 1
EMA 2
Health Canada 1
Safety 5

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
MEKTOVI	15 mg	Film-coated tablet · Oral use	84 Blister	SAR 10134.65	NCE · Prescription	Pfizer Europe MA EEIG	Valid

Indications — CHI Daman Drug Formulary

MELANOMA

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
MEKTOVI	15MG	tablet · oral	ARRAY BIOPHARMA INC	Prescription	27 Jun 2018

EMA European Union — centrally authorised medicines

Mektovi Pierre Fabre Medicament · Authorised · authorised 20 Sep 2018 · ATC L01EE03

Therapeutic indication (EMA)

MelanomaBinimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.Non-small cell lung cancer (NSCLC)Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation.

Balimek Pierre Fabre Médicament · Application withdrawn · ATC L01XE

Therapeutic indication (EMA)

Treatment of unresectable or metastatic melanoma. Treatment of unresectable melanoma, with NRA Q61 mutation.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
MEKTOVI	02513080	15 MG	TABLET · ORAL	PFIZER CANADA ULC

Safety signals and safety-related labeling changes

EMA PRAC 10 Apr 2026 PRAC signal: Neutropenia, febrile neutropenia
Action for MAH: update of the product information: No
EMA PRAC 4 Sep 2025 PRAC signal: Tattoo associated skin reaction
Action for MAH: update of the product information: Yes
EMA PRAC 13 Mar 2025 PRAC signal: Tattoo associated skin reaction
Action for MAH: update of the product information: No
US FDA 12 Sep 2024 MEKTOVI — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 6 Jul 2023 PRAC signal: Tumour lysis syndrome
Action for MAH: update of the product information: No

All safety entries for binimetinib →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.