human coagulation factor X

This medicine is authorised for use in the European Union.


Coagadex is a medicine used for the treatment and prevention of bleeding (including during and after an operation) in patients with hereditary factor X deficiency. Factor X deficiency is a bleeding disorder caused by lack of factor X, a protein needed for normal clotting of the blood.

Factor X deficiency is rare and Coagadex was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 14 September 2007. Further information on the orphan designation can be found on EU/3/07/471 page.

Coagadex contains the active substance human coagulation factor X.

This EPAR was last updated on 25/01/2023

Authorisation details

Product details
Agency product number
Active substance
Human coagulation factor X
International non-proprietary name (INN) or common name
human coagulation factor X
Therapeutic area (MeSH)
Factor X Deficiency
Anatomical therapeutic chemical (ATC) code
Accelerated assessmentAccelerated assessment

This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.


This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
BPL Bioproducts Laboratory GmbH
Date of issue of marketing authorisation valid throughout the European Union
Contact address

BPL Bioproducts Laboratory GmbH
63263 Neu-Isenburg

Product information

17/01/2023 Coagadex - EMEA/H/C/003855 - N/0049

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

  • Vitamin K and other hemostatics

  • Antihemorrhagics

  • coagulation factor X

Therapeutic 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.

Assessment history

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