EMA
- Application: EMEA/H/C/004386
- Local brand name: Gamifant
- Status: refused
Gamifant (EMAPALUMAB) regulatory status in European Union.
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. EMA has authorised it.
Novimmune S.A. is the originator. The local marketing authorisation holder may differ — check the official source linked above.