Welireg
What Welireg is used for
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.
Approved use, as published by the European Medicines Agency.
What the labels mean
- Conditional approval: approved on less complete data because the need is high; more data must follow.
Key facts
- Brand
- Welireg
- Active substance
- belzutifan
- Disease area
- Carcinoma, Renal Cell; von Hippel-Lindau Disease
- Medicine group
- Antineoplastic agents
- ATC code
- L01XX74
- Marketing authorisation holder
- Merck Sharp & Dohme B.V.
- Authorised in the EU since
- 2025
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 Welireg used for?
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), an…
What is the active substance in Welireg?
Welireg contains belzutifan.
Who makes Welireg?
The EU marketing authorisation holder is Merck Sharp & Dohme B.V..
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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