🇪🇺 rurioctocog alfa pegol in European Union

EMA authorised rurioctocog alfa pegol on 8 January 2018

Marketing authorisation

EMA — authorised 8 January 2018

  • Application: EMEA/H/C/004195
  • Marketing authorisation holder: Baxalta Innovations GmbH
  • Local brand name: Adynovi
  • Indication: Treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia A (congenital factor VIII deficiency).
  • Status: approved

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rurioctocog alfa pegol in other countries

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

Frequently asked questions

Is rurioctocog alfa pegol approved in European Union?

Yes. EMA authorised it on 8 January 2018.

Who is the marketing authorisation holder for rurioctocog alfa pegol in European Union?

Baxalta Innovations GmbH holds the EU marketing authorisation.