EMA
approval
· 2025-11-18
EMA Authorised: Ozawade (pitolisant) — Bioprojet Pharma
Summary
EMA authorised Ozawade (pitolisant) by Bioprojet Pharma. It is indicated for obstructive sleep apnea.
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Diseases / indications
Drugs mentioned
Snippet
Status: Authorised. Therapeutic area: Sleep Apnea, Obstructive. MAH: Bioprojet Pharma. Decision date: 16/10/2025