🇪🇺 Factor VIII (FVIII) in European Union

EMA authorised Factor VIII (FVIII) on 18 February 2016

Marketing authorisations

EMA — authorised 18 February 2016

  • Application: EMEA/H/C/003825
  • Marketing authorisation holder: Bayer AG
  • Local brand name: Kovaltry
  • Indication: Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Kovaltry can be used for all age groups.
  • Status: approved

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EMA — authorised 4 January 2017

  • Application: EMEA/H/C/004075
  • Marketing authorisation holder: CSL Behring GmbH
  • Local brand name: Afstyla
  • Indication: Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Afstyla can be used for all age groups.
  • Status: approved

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Factor VIII (FVIII) in other countries

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

Other Hematology approved in European Union

Frequently asked questions

Is Factor VIII (FVIII) approved in European Union?

Yes. EMA authorised it on 18 February 2016; EMA authorised it on 4 January 2017.

Who is the marketing authorisation holder for Factor VIII (FVIII) in European Union?

Bayer AG holds the EU marketing authorisation.