Is Encorafenib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Encorafenib, including BRAFTOVI (50 mg, Capsule, hard, SAR 2252.15); BRAFTOVI (75 mg, Capsule, hard, SAR 5067.30).

Is Encorafenib approved by the US FDA?

Drugs@FDA lists 2 application product lines for Encorafenib, including BRAFTOVI (Prescription); BRAFTOVI (Discontinued).

Is Encorafenib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Encorafenib: Braftovi.

Are there safety signals or safety updates for Encorafenib?

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

Active substance

Encorafenib

SFDA 2
US FDA 2
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
BRAFTOVI	50 mg	Capsule, hard · Oral use	28 Blister	SAR 2252.15	NCE · Prescription	Pfizer Europe MA EEIG	Valid
BRAFTOVI	75 mg	Capsule, hard · Oral use	42 Blister	SAR 5067.30	NCE · Prescription	Pfizer Europe MA EEIG	Valid

Indications — CHI Daman Drug Formulary

COLORECTAL CANCER-ADVANCED/ METASTATIC; MELANOMA

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

Product	Strength	Form · route	Applicant	Status	First approved
BRAFTOVI	75MG	capsule · oral	ARRAY BIOPHARMA INC	Prescription	27 Jun 2018
BRAFTOVI	50MG	capsule · oral	ARRAY BIOPHARMA INC	Discontinued	27 Jun 2018

EMA European Union — centrally authorised medicines

Braftovi Pierre Fabre Medicament · Authorised · authorised 19 Sep 2018 · ATC L01EC03

Therapeutic indication (EMA)

MelanomaEncorafenib in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.Colorectal cancer (CRC)Encorafenib in combination with cetuximab is indicated for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, who have received prior systemic therapy. Encorafenib in combination with cetuximab and FOLFOX is indicated for the first line treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation. Non-small cell lung cancer (NSCLC)Encorafenib in combination with binimetinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
BRAFTOVI	02513099	75 MG	CAPSULE · 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
US FDA 24 Feb 2026 BRAFTOVI — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; 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 6 Jul 2023 PRAC signal: Tumour lysis syndrome
Action for MAH: update of the product information: No

All safety entries for encorafenib →

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.