Is Vemurafenib 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 Vemurafenib, including ZELBORAF 240 mg film-coated tablet (240 mg, Film-coated tablet, SAR 7210.00).

Is Vemurafenib approved by the US FDA?

Drugs@FDA lists 1 application product line for Vemurafenib, including ZELBORAF (Prescription).

Is Vemurafenib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Vemurafenib: Zelboraf.

Are there safety signals or safety updates for Vemurafenib?

EMA PRAC: 9 entries; US FDA: 1 entry; MHRA: 1 entry (latest 2026-08-20).

Active substance

Vemurafenib

SFDA 1
US FDA 1
EMA 1
Health Canada 1
Safety 11

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ZELBORAF 240 mg film-coated tablet	240 mg	Film-coated tablet · Oral use	56 Blister	SAR 7210.00	NCE · Prescription	ROCHE	Valid

Indications — CHI Daman Drug Formulary

MELANOMA; NON-SMALL-CELL LUNG CARCINOMA (NSCLC); THYROID CANCER-PAPILLARY, FOLLICULAR, HURTHLE CELL CARCINOMA

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

Product	Strength	Form · route	Applicant	Status	First approved
ZELBORAF	240MG	tablet · oral	HOFFMANN LA ROCHE	Prescription	17 Aug 2011

EMA European Union — centrally authorised medicines

Zelboraf Roche Registration GmbH · Authorised · authorised 17 Feb 2012 · ATC L01EC01

Therapeutic indication (EMA)

Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF-V600-mutation-positive unresectable or metastatic melanoma.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ZELBORAF	02380242	240 MG	TABLET · ORAL	HOFFMANN-LA ROCHE LIMITED

Safety signals and safety-related labeling changes

US FDA 20 Aug 2026 ZELBORAF — 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 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
EMA PRAC 29 Nov 2018 PRAC signal: Cardiac failure
Action for MAH: update of the product information: No
EMA PRAC 12 Jul 2018 PRAC signal: Cardiac failure
Action for MAH: update of the product information: No
MHRA 12 Nov 2015 Vemurafenib (Zelboraf▼): risk of potentiation of radiation toxicity
Prescribers should be aware of the risk of potentiation of radiation toxicity with vemurafenib when given before, during, or after radiotherapy
EMA PRAC 6 Nov 2014 PRAC signal: Dupuytren’s contracture
Action for MAH: update of the product information: No
EMA PRAC 5 Sep 2013 PRAC signal: Renal failure
Action for MAH: update of the product information: No
EMA PRAC 5 Sep 2012 PRAC signal: Pancreatitis
Action for MAH: update of the product information: No

All safety entries for vemurafenib →

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.