🇪🇺 Winrevair in European Union

Winrevair (SOTATERCEPT) regulatory status in European Union.

Marketing authorisation

EMA

  • Application: EMEA/H/C/005647
  • Local brand name: Winrevair
  • Status: approved

Winrevair in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Cardiovascular approved in European Union

Frequently asked questions

Is Winrevair approved in European Union?

Yes. EMA has authorised it.

Who is the marketing authorisation holder for Winrevair in European Union?

Merck Sharp Dohme is the originator. The local marketing authorisation holder may differ — check the official source linked above.