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EMA approval · 2025-08-28

EMA Authorised: Zolgensma (onasemnogene abeparvovec) — Novartis Europharm Limited

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Summary

The EMA authorised Zolgensma (onasemnogene abeparvovec) for spinal muscular atrophy under conditional, orphan designation, with Novartis Europharm Limited as th…

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Diseases / indications

Drugs mentioned

  • Zolgensma (onasemnogene abeparvovec)

Snippet

Status: Authorised. Therapeutic area: Muscular Atrophy, Spinal. MAH: Novartis Europharm Limited. Decision date: 27/08/2025. Conditional approval. Orphan medicine