EMA European Union — centrally authorised medicines
Advate Takeda Manufacturing Austria AG · Authorised · authorised 2 Mar 2004 · ATC B02BD02
Therapeutic indication (EMA)
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor-VIII deficiency). Advate does not contain von Willebrand factor in pharmacologically effective quantities and is therefore not indicated in von Willebrand disease.
Kovaltry Bayer AG · Authorised · authorised 18 Feb 2016 · ATC B02BD02
Therapeutic indication (EMA)
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Kovaltry can be used for all age groups.
Kogenate Bayer Bayer AG · Lapsed · authorised 4 Aug 2000 · ATC B02BD02
Therapeutic indication (EMA)
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor-VIII deficiency). This preparation does not contain von Willebrand factor and is therefore not indicated in von Willebrand's disease.
Helixate NexGen Bayer AG · Withdrawn · authorised 4 Aug 2000 · ATC B02BD02
Therapeutic indication (EMA)
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor-VIII deficiency). This preparation does not contain von Willebrand factor and is therefore not indicated in von Willebrand's disease.
Iblias Bayer AG · Withdrawn · authorised 18 Feb 2016 · ATC B02BD02
Therapeutic indication (EMA)
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).Iblias can be used for all age groups.
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), 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.