🇪🇺 human coagulation Factor IX in European Union

EMA authorised human coagulation Factor IX on 3 July 2001

Marketing authorisation

EMA — authorised 3 July 2001

  • Application: EMEA/H/C/000348
  • Marketing authorisation holder: Sanquin Plasma Products B.V.
  • Local brand name: Nonafact
  • Indication: Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).
  • Status: withdrawn

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human coagulation Factor IX 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 human coagulation Factor IX approved in European Union?

Yes. EMA authorised it on 3 July 2001.

Who is the marketing authorisation holder for human coagulation Factor IX in European Union?

Sanquin Plasma Products B.V. holds the EU marketing authorisation.