Mepsevii (vestronidase alfa)
OrphanExceptional circumstancesAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- vestronidase alfa
- Company
- Ultragenyx Germany GmbH
- Status
- Authorised
- Therapeutic area
- Mucopolysaccharidosis VII
- CHMP opinion
- Thu 26 Apr 2018
- EU approval
- Thu 23 Aug 2018
- Designations
- Orphan, Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/004438
- ATC
- A16AB18
- Official record
- www.ema.europa.eu
Indication
Mepsevii is indicated for the treatment of non-neurological manifestations of Mucopolysaccharidosis VII (MPS VII; Sly syndrome).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.