EMA
approval
· 2025-12-04
EMA Authorised: Hetlioz (tasimelteon) — Vanda Pharmaceuticals Netherlands B.V.
Summary
Hetlioz (tasimelteon) has been authorised in the EU for a circadian rhythm sleep-wake disorder, notably non-24-hour sleep-wake rhythm disorder.
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Diseases / indications
Drugs mentioned
Snippet
Status: Authorised. Therapeutic area: Sleep Disorders, Circadian Rhythm. MAH: Vanda Pharmaceuticals Netherlands B.V.. Decision date: 10/10/2022