FDA — authorised 26 March 2024
- Application: BLA761363
- Marketing authorisation holder: MERCK SHARP DOHME
- Local brand name: WINREVAIR
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 WINREVAIR in United States
FDA authorised WINREVAIR on 26 March 2024
Marketing authorisation
WINREVAIR in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is WINREVAIR approved in United States?
Yes. FDA authorised it on 26 March 2024.
Who is the marketing authorisation holder for WINREVAIR in United States?
MERCK SHARP DOHME holds the US marketing authorisation.