Regulatory PathRegulatory requirements compared

Active substance

Human coagulation factor x

Open in the medicines table

EMA European Union — centrally authorised medicines

Coagadex Kedrion S.p.A. · Authorised · authorised 16 Mar 2016 · ATC B02BD13

Therapeutic indication (EMA)

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.

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
COAGADEX 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION.PLGB 08801/0059BIO PRODUCTS LABORATORY LIMITEDPOM
COAGADEX 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTIONPLGB 08801/0060BIO PRODUCTS LABORATORY LIMITEDPOM

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.