FDA — authorised 5 October 2018
- Marketing authorisation holder: LEADIANT BIOSCI INC
- Status: approved
🇺🇸 Revcovi in United States
FDA authorised Revcovi on 5 October 2018
Marketing authorisations
FDA — authorised 5 December 2020
- Application: BLA761092
- Marketing authorisation holder: CHIESI USA INC
- Indication: Labeling
- Status: approved
Revcovi in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Revcovi approved in United States?
Yes. FDA authorised it on 5 October 2018; FDA authorised it on 5 December 2020.
Who is the marketing authorisation holder for Revcovi in United States?
LEADIANT BIOSCI INC holds the US marketing authorisation.