🇪🇺 Benefix in European Union

EMA authorised Benefix on 27 August 1997

Marketing authorisation

EMA — authorised 27 August 1997

  • Application: EMEA/H/C/000139
  • Marketing authorisation holder: Pfizer Europe MA EEIG
  • Local brand name: BeneFIX
  • Indication: Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor-IX deficiency).
  • Status: approved

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Benefix in other countries

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

Other Other approved in European Union

Frequently asked questions

Is Benefix approved in European Union?

Yes. EMA authorised it on 27 August 1997.

Who is the marketing authorisation holder for Benefix in European Union?

Pfizer Europe MA EEIG holds the EU marketing authorisation.