Regulatory PathRegulatory requirements compared

Active substance

Vonicog alfa

Open in the medicines table

EMA European Union — centrally authorised medicines

Veyvondi Baxalta Innovations GmbH · Authorised · authorised 31 Aug 2018 · ATC B02BD10

Therapeutic indication (EMA)

Prevention and treatment of haemorrhage or surgical bleeding in adults (age 18 years and older) with von Willebrand disease (VWD), when desmopressin (DDAVP) treatment alone is ineffective or contraindicated. Veyvondi should not be used in the treatment of Haemophilia A.

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
VEYVONDI 1300 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTIONPLGB 34078/0032BAXALTA INNOVATIONS GMBHPOM
VEYVONDI 650 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTIONPLGB 34078/0031BAXALTA INNOVATIONS GMBHPOM

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.