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EMA approval · 2026-03-27

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

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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

  • Duvyzat

Snippet

Status: Authorised. Therapeutic area: Muscular Dystrophy, Duchenne. MAH: Italfarmaco S.p.A.. Decision date: 17/07/2025. Conditional approval. Orphan medicine