🇪🇺 Recombinant Coagulation Factor Ix in European Union

EMA authorised Recombinant Coagulation Factor Ix on 27 August 1997

Marketing authorisation

EMA — authorised 27 August 1997

  • Marketing authorisation holder: Pfizer Ltd
  • Status: approved

Recombinant 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.

Other Metabolic approved in European Union

Frequently asked questions

Is Recombinant Coagulation Factor Ix approved in European Union?

Yes. EMA authorised it on 27 August 1997.

Who is the marketing authorisation holder for Recombinant Coagulation Factor Ix in European Union?

Pfizer Ltd holds the EU marketing authorisation.