EMA
approval
· 2026-01-16
EMA Authorised: Namuscla (Mexiletine hydrochloride) — Lupin Europe GmbH
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
Snippet
Status: Authorised. Therapeutic area: Myotonic Disorders. MAH: Lupin Europe GmbH. Decision date: 27/11/2025. Orphan medicine