Is Belzutifan 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 Belzutifan, including Welireg (40 mg, Film-coated tablet, SAR 68062.50).

Is Belzutifan approved by the US FDA?

Drugs@FDA lists 1 application product line for Belzutifan, including WELIREG (Prescription).

Is Belzutifan authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Belzutifan: Welireg.

Are there safety signals or safety updates for Belzutifan?

EMA PRAC: 1 entry; US FDA: 1 entry (latest 2026-09-24).

Active substance

Belzutifan

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

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Welireg	40 mg	Film-coated tablet · Oral use	90 Bottle	SAR 68062.50	NCE · Prescription	MERCK SHARP & DOHME LIMITED	Valid

Indications — CHI Daman Drug Formulary

NEUROENDOCRINE TUMORS; RENAL CELL CARCINOMA (RCC)-CC-RCC & NON-CC RCC

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

Product	Strength	Form · route	Applicant	Status	First approved
WELIREG	40MG	tablet · oral	MERCK SHARP DOHME	Prescription	13 Aug 2021

EMA European Union — centrally authorised medicines

Welireg Merck Sharp & Dohme B.V. · Authorised · authorised 12 Feb 2025 · ATC L01XX74

Therapeutic indication (EMA)

Renal cell carcinoma (RCC) Welireg is indicated as monotherapy for the treatment of adult patients with advanced clear cell renal cell carcinoma that progressed following two or more lines of therapy that included a PD-(L)1 inhibitor and at least two VEGF-targeted therapies. von Hippel-Lindau (VHL) disease-associated tumours Welireg is indicated as monotherapy for the treatment of adult patients with von Hippel-Lindau disease who require therapy for associated, localised renal cell carcinoma (RCC), central nervous system (CNS) haemangioblastomas, or pancreatic neuroendocrine tumours (pNET), and for whom localised procedures are unsuitable.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
WELIREG	02528908	40 MG	TABLET · ORAL	MERCK CANADA INC

Safety signals and safety-related labeling changes

US FDA 24 Sep 2026 WELIREG — 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 11 Jun 2026 PRAC signal: Retinal oedema
Action for MAH: update of the product information: No

All safety entries for belzutifan →

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.