Posted by Michael Wonder on 28 Mar 2026
Richter receives European Commission approval for Fylrevy (estetrol tablet) as hormonal replacement therapy
27 March 2026 - Gedeon Richter announces today that the European Commission granted approval for the marketing authorisation of Fylrevy (estetrol; developed under the name Donesta) as hormone replacement therapy for oestrogen deficiency symptoms in post-menopausal women.
This decision followed a positive opinion received from the CHMP of the EMA, as reported on 30 January 2026, and is applicable for all member states of the European Economic Area.
