🇪🇺 Refixia® in European Union

EMA authorised Refixia® on 2 June 2017

Marketing authorisation

EMA — authorised 2 June 2017

  • Application: EMEA/H/C/004178
  • Marketing authorisation holder: Novo Nordisk A/S
  • Local brand name: Refixia
  • Indication: Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency). Refixia can be used for all age groups.
  • Status: approved

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Refixia® in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Refixia® approved in European Union?

Yes. EMA authorised it on 2 June 2017.

Who is the marketing authorisation holder for Refixia® in European Union?

Novo Nordisk A/S holds the EU marketing authorisation.