Mepsevii Ultragenyx Germany GmbH · Authorised · authorised 23 Aug 2018 · ATC A16AB18
Therapeutic indication (EMA)
Mepsevii is indicated for the treatment of non-neurological manifestations of Mucopolysaccharidosis VII (MPS VII; Sly syndrome).
Active substance
Vestronidase alfa
- EMA 1
- UK MHRA 1
EMA European Union — centrally authorised medicines
UK MHRA United Kingdom — marketing authorisations
| Product | Authorisation | Holder | Legal status |
|---|---|---|---|
| MEPSEVII 2 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION | PLGB 47793/0002 | ULTRAGENYX GERMANY GMBH | POM |
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.