Coagadex

human coagulation factor X · Kedrion S.p.A.
ORPHAN AUTHORISED IN THE EU

What Coagadex is used for

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.

Approved use, as published by the European Medicines Agency.

What the labels mean

  • Orphan medicine: for a rare disease (affecting no more than 5 in 10,000 people in the EU).

Key facts

Brand
Coagadex
Active substance
human coagulation factor X
Disease area
Factor X Deficiency
Medicine group
Vitamin K and other hemostatics;Antihemorrhagics;coagulation factor X
ATC code
B02BD13
Marketing authorisation holder
Kedrion S.p.A.
Authorised in the EU since
2016

Official information

In the USA

Same active substance: Coagadex, Balfaxar

Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.

Common questions

What is Coagadex used for?

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.

What is the active substance in Coagadex?

Coagadex contains human coagulation factor X.

Who makes Coagadex?

The EU marketing authorisation holder is Kedrion S.p.A..

Is Coagadex an orphan medicine?

Yes. Coagadex is designated an orphan medicine in the EU, for a rare disease (Factor X Deficiency).

Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.

← All specialty medicines, EU

For information only, not medical advice. This page is a plain-language summary written from standard prescribing information and the public guides linked below. Brands sometimes change their formula, so always check the composition printed on the pack. Doses here are typical adult doses; yours may differ. Do not start, stop or change a medicine without your doctor or pharmacist, and keep all medicines away from children. In an emergency, call 112 (India) or your local emergency number.