Agamree (vamorolone)
OrphanAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- vamorolone
- Company
- Santhera Pharmaceuticals (Deutschland) GmbH
- Status
- Authorised
- Therapeutic area
- Muscular Dystrophy, Duchenne
- CHMP opinion
- Thu 12 Oct 2023
- EU approval
- Thu 14 Dec 2023
- Designations
- Orphan, Additional monitoring
- Application
- EMEA/H/C/005679
- ATC
- H02AB18
- Official record
- www.ema.europa.eu
Indication
Agamree is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 2 years and older.
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.