EMA Authorised: Duvyzat (givinostat hydrochloride monohydrate) — Italfarmaco S.p.A.

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Summary

EMA authorised Duvyzat (givinostat hydrochloride monohydrate) for Duchenne muscular dystrophy under conditional and orphan designation.

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Diseases / indications

• Duchenne Muscular Dystrophy

Drugs mentioned

• Duvyzat

Snippet

Status: Authorised. Therapeutic area: Muscular Dystrophy, Duchenne. MAH: Italfarmaco S.p.A.. Decision date: 02/07/2026. Conditional approval. Orphan medicine