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EMA approval · 2026-01-16

EMA Authorised: Namuscla (Mexiletine hydrochloride) — Lupin Europe GmbH

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Summary

The European Medicines Agency authorised Namuscla (mexiletine hydrochloride) for myotonic disorders under Lupin Europe GmbH, with orphan designation.

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Diseases / indications

Drugs mentioned

  • Namuscla (Mexiletine hydrochloride)

Snippet

Status: Authorised. Therapeutic area: Myotonic Disorders. MAH: Lupin Europe GmbH. Decision date: 27/11/2025. Orphan medicine