EMA — authorised 13 November 2013
- Marketing authorisation holder: Novo Nordisk A/S
- Status: approved
🇪🇺 Novoeight in European Union
EMA authorised Novoeight on 13 November 2013
Marketing authorisations
EMA — authorised 13 November 2013
- Application: EMEA/H/C/002719
- Marketing authorisation holder: Novo Nordisk A/S
- Local brand name: NovoEight
- Indication: Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Novoeight can be used for all age groups.
- Status: approved
Novoeight 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 Novoeight approved in European Union?
Yes. EMA authorised it on 13 November 2013; EMA authorised it on 13 November 2013.
Who is the marketing authorisation holder for Novoeight in European Union?
Novo Nordisk A/S holds the EU marketing authorisation.