EMA — authorised 23 February 1996
- Marketing authorisation holder: Novo Nordisk A/S
- Status: approved
🇪🇺 Eptacog Alfa in European Union
EMA authorised Eptacog Alfa on 23 February 1996
Marketing authorisations
EMA — authorised 19 May 2022
- Application: EMEA/H/C/005547
- Marketing authorisation holder: UGA Biopharma
- Local brand name: HemAryo
- Indication: Treatment of bleeding episodes and for the prevention of bleeding.
- Status: withdrawn
Eptacog Alfa in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Rare Disease approved in European Union
Frequently asked questions
Is Eptacog Alfa approved in European Union?
Yes. EMA authorised it on 23 February 1996; EMA authorised it on 19 May 2022.
Who is the marketing authorisation holder for Eptacog Alfa in European Union?
Novo Nordisk A/S holds the EU marketing authorisation.