Duvyzat (givinostat)
OrphanConditionalAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- givinostat
- Company
- Italfarmaco S.p.A.
- Status
- Authorised
- Therapeutic area
- Muscular Dystrophy, Duchenne
- CHMP opinion
- Fri 25 Apr 2025
- EU approval
- Fri 06 Jun 2025
- Designations
- Orphan, Conditional, Additional monitoring
- Application
- EMEA/H/C/006079
- ATC
- M09AX14
- Official record
- www.ema.europa.eu
Indication
Duvyzat is indicated for the treatment of Duchenne muscular dystrophy (DMD) in ambulant patients, aged 6 years and older, and with concomitant corticosteroid treatment.
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.