FDA — authorised 20 November 2018
- Marketing authorisation holder: NOVIMMUNE S.A.
- Status: approved
🇺🇸 Gamifant in United States
FDA authorised Gamifant on 20 November 2018
Marketing authorisations
FDA — authorised 26 June 2020
- Application: BLA761107
- Marketing authorisation holder: NOVIMMUNE S.A.
- Indication: Manufacturing (CMC)
- Status: approved
Gamifant 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 Gamifant approved in United States?
Yes. FDA authorised it on 20 November 2018; FDA authorised it on 26 June 2020.
Who is the marketing authorisation holder for Gamifant in United States?
NOVIMMUNE S.A. holds the US marketing authorisation.