Is Cobimetinib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Cobimetinib.

Is Cobimetinib approved by the US FDA?

Drugs@FDA lists 1 application product line for Cobimetinib, including COTELLIC (Prescription).

Is Cobimetinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Cobimetinib: Cotellic.

Are there safety signals or safety updates for Cobimetinib?

EMA PRAC: 4 entries; US FDA: 1 entry (latest 2026-08-20).

Active substance

Cobimetinib

SFDA 1
US FDA 1
EMA 1
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
COTELLIC 20 mg film-coated tablet	20 mg	Film-coated tablet · Oral use	63 Blister	SAR 23041.95	NCE · Prescription	ROCHE	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
COTELLIC	EQ 20MG BASE	tablet · oral	GENENTECH INC	Prescription	10 Nov 2015

EMA European Union — centrally authorised medicines

Cotellic Roche Registration GmbH · Authorised · authorised 20 Nov 2015 · ATC L01XE38

Therapeutic indication (EMA)

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.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
COTELLIC	02452340	20 MG	TABLET · ORAL	HOFFMANN-LA ROCHE LIMITED

Safety signals and safety-related labeling changes

US FDA 20 Aug 2026 COTELLIC — 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 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
EMA PRAC 11 Jan 2024 PRAC signal: Aphthous ulcer, mouth ulceration, stomatitis
Action for MAH: update of the product information: Yes
EMA PRAC 31 Aug 2023 PRAC signal: Aphthous ulcer, mouth ulceration, stomatitis
Action for MAH: update of the product information: No

All safety entries for cobimetinib →

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.