Prognia
Drug Database
🇪🇺EU · EMAAuthorisedATC: M09AX14Orphan MedicineConditional Approval

Duvyzat(givinostat hydrochloride monohydrate)

Muscular Dystrophy, Duchenne

Marketing Authorisation Holder: Italfarmaco S.p.A.

EMA Authorisation: 06/06/2025

INN: givinostat

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.

Official EMA Resources

View on EMA (ema.europa.eu)

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Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.