🇪🇺 Esperoct in European Union

EMA authorised Esperoct on 20 June 2019

Marketing authorisation

EMA — authorised 20 June 2019

  • Application: EMEA/H/C/004883
  • Marketing authorisation holder: Novo Nordisk A/S
  • Local brand name: Esperoct
  • Indication: Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).Esperoct can be used for all age groups.
  • Status: approved

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Esperoct 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 Esperoct approved in European Union?

Yes. EMA authorised it on 20 June 2019.

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

Novo Nordisk A/S holds the EU marketing authorisation.