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EMA approval · 2026-03-11

EMA Authorised: Spinraza (nusinersen sodium) — Biogen Netherlands B.V.

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Summary

The European Medicines Agency authorised Spinraza (nusinersen) by Biogen Netherlands B.V. for spinal muscular atrophy, with orphan medicine designation and acce…

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Diseases / indications

Drugs mentioned

  • Spinraza (nusinersen)

Snippet

Status: Authorised. Therapeutic area: Muscular Atrophy, Spinal. MAH: Biogen Netherlands B.V.. Decision date: 09/01/2026. Orphan medicine. Accelerated assessment