Rezurock

belumosudil · Sanofi Winthrop Industrie
ORPHAN CONDITIONAL APPROVAL AUTHORISED IN THE EU

What Rezurock is used for

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.

Approved use, as published by the European Medicines Agency.

What the labels mean

  • Orphan medicine: for a rare disease (affecting no more than 5 in 10,000 people in the EU).
  • Conditional approval: approved on less complete data because the need is high; more data must follow.

Key facts

Brand
Rezurock
Active substance
belumosudil
Disease area
Graft vs Host Disease
Medicine group
Immunosuppressants
ATC code
L04AA48
Marketing authorisation holder
Sanofi Winthrop Industrie
Authorised in the EU since
2026

Official information

Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.

Common questions

What is Rezurock used for?

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.

What is the active substance in Rezurock?

Rezurock contains belumosudil.

Who makes Rezurock?

The EU marketing authorisation holder is Sanofi Winthrop Industrie.

Is Rezurock an orphan medicine?

Yes. Rezurock is designated an orphan medicine in the EU, for a rare disease (Graft vs Host Disease).

Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.

← All specialty medicines, EU

For information only, not medical advice. This page is a plain-language summary written from standard prescribing information and the public guides linked below. Brands sometimes change their formula, so always check the composition printed on the pack. Doses here are typical adult doses; yours may differ. Do not start, stop or change a medicine without your doctor or pharmacist, and keep all medicines away from children. In an emergency, call 112 (India) or your local emergency number.