🇪🇺 Coagadex in European Union

EMA authorised Coagadex on 16 March 2016

Marketing authorisation

EMA — authorised 16 March 2016

  • Application: EMEA/H/C/003855
  • Marketing authorisation holder: Kedrion S.p.A.
  • Local brand name: Coagadex
  • Indication: Coagadex is indicated for the treatment and prophylaxis of bleeding episodes and for perioperative management in patients with hereditary factor X deficiency. Coagadex is indicated in all age groups.
  • Pathway: accelerated assessment, orphan
  • Status: approved

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Coagadex 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 Coagadex approved in European Union?

Yes. EMA authorised it on 16 March 2016.

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

Kedrion S.p.A. holds the EU marketing authorisation.