EMA
approval
· 2026-03-27
EMA Authorised: Duvyzat (givinostat hydrochloride monohydrate) — Italfarmaco S.p.A.
Summary
The European Medicines Agency authorised Duvyzat, containing givinostat hydrochloride monohydrate, for Duchenne muscular dystrophy under a conditional, orphan-d…
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Diseases / indications
Drugs mentioned
Snippet
Status: Authorised. Therapeutic area: Muscular Dystrophy, Duchenne. MAH: Italfarmaco S.p.A.. Decision date: 17/07/2025. Conditional approval. Orphan medicine