Is Belumosudil 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 Belumosudil, including Rezurock (200 mg, Film-coated tablet, SAR 34581.50).

Is Belumosudil approved by the US FDA?

Drugs@FDA lists 1 application product line for Belumosudil, including REZUROCK (Prescription).

Is Belumosudil authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Belumosudil: Rezurock.

Are there safety signals or safety updates for Belumosudil?

US FDA: 1 entry (latest 2026-01-15).

Active substance

Belumosudil

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

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Rezurock	200 mg	Film-coated tablet · Oral use	30 Bottle	SAR 34581.50	NCE · Prescription	SANOFI WINTHROP INDUSTRIE	Valid

Indications — CHI Daman Drug Formulary

GRAFT VERSUS HOST DISEASE - CHRONIC

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

Product	Strength	Form · route	Applicant	Status	First approved
REZUROCK	EQ 200MG BASE	tablet · oral	KADMON PHARMS LLC	Prescription	16 Jul 2021

EMA European Union — centrally authorised medicines

Rezurock Sanofi Winthrop Industrie · Authorised · authorised 24 Mar 2026 · ATC L04AA48

Therapeutic indication (EMA)

Rezurock is indicated for the treatment of adults and paediatric patients (12 years and older with a body weight of at least 40 kg) with chronic graft-versus-host disease (cGVHD) when other treatment options provide limited clinical benefit, are not suitable, or have been exhausted.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
REZUROCK	02526115	200 MG	TABLET · ORAL	SANOFI-AVENTIS CANADA INC

Safety signals and safety-related labeling changes

US FDA 15 Jan 2026 REZUROCK — safety-related labeling change
Labeling sections changed: Drug Interactions; Use in Specific Populations

All safety entries for belumosudil →

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.