Basic Information
Coagadex
Regulatory Information
EMEA/H/C/003855
March 16, 2016
January 28, 2016
10
January 25, 2023
Company Information
Germany
BPL Bioproducts Laboratory GmbH Dornhofstrasse 63263 Neu-Isenburg
BPL Bioproducts Laboratory GmbH
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### 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.
Overview Summary
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](/en/medicines/human/orphan-designations/eu-3-07-471) page. Coagadex contains the active substance human coagulation factor X.