EMA
approval
· 2026-04-09
EMA Authorised: Fylrevy (estetrol monohydrate) — Gedeon Richter Plc.
Summary
EMA authorised Fylrevy (estetrol monohydrate) for menopausal hormone therapy. Gedeon Richter Plc. is the marketing authorisation holder.
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Diseases / indications
Drugs mentioned
Snippet
Status: Authorised. Therapeutic area: Menopause. MAH: Gedeon Richter Plc.. Decision date: 26/03/2026