Winrevair
What Winrevair is used for
Winrevair, in combination with other pulmonary arterial hypertension (PAH) therapies, is indicated for the treatment of PAH in adult patients with WHO Functional Class (FC) II, III and IV.
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).
- PRIME: a priority medicine that the EMA supported early because it may meet an unmet need.
Key facts
- Brand
- Winrevair
- Active substance
- sotatercept
- Disease area
- Hypertension, Pulmonary
- Medicine group
- Antihypertensives
- ATC code
- C02KX06
- Marketing authorisation holder
- Merck Sharp & Dohme B.V.
- Authorised in the EU since
- 2024
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 Winrevair used for?
Winrevair, in combination with other pulmonary arterial hypertension (PAH) therapies, is indicated for the treatment of PAH in adult patients with WHO Functional Class (FC) II, III and IV.
What is the active substance in Winrevair?
Winrevair contains sotatercept.
Who makes Winrevair?
The EU marketing authorisation holder is Merck Sharp & Dohme B.V..
Is Winrevair an orphan medicine?
Yes. Winrevair is designated an orphan medicine in the EU, for a rare disease (Hypertension, Pulmonary).
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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