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EMA approval · 2026-04-09

EMA Authorised: Fylrevy (estetrol monohydrate) — Gedeon Richter Plc.

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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

  • Fylrevy (estetrol monohydrate)

Snippet

Status: Authorised. Therapeutic area: Menopause. MAH: Gedeon Richter Plc.. Decision date: 26/03/2026