🇪🇺 Elocta in European Union

EMA authorised Elocta on 18 November 2015

Marketing authorisations

EMA — authorised 18 November 2015

  • Application: EMEA/H/C/003964
  • Marketing authorisation holder: Swedish Orphan Biovitrum AB (publ)
  • Local brand name: Elocta
  • Indication: Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Elocta can be used for all age groups.
  • Status: approved

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EMA — authorised 19 November 2015

  • Marketing authorisation holder: Swedish Orphan Biovitrum AB
  • Status: approved

Elocta 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 Elocta approved in European Union?

Yes. EMA authorised it on 18 November 2015; EMA authorised it on 19 November 2015.

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

Swedish Orphan Biovitrum AB (publ) holds the EU marketing authorisation.