Gedeon Richter and Myovant Sciences Receive Positive CHMP Opinion for RYEQO® (Relugolix Combination Tablet) for the Treatment of Uterine Fibroids.

Budapest, Hungary – 21 May 2021 – Gedeon Richter Plc. (“Richter”) announces that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) has adopted a positive opinion recommending approval of RYEQO ® (relugolix 40 mg, estradiol 1.0 mg, and norethisterone acetate 0.5 mg) for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. The European Commission (“EC”) will review the CHMP recommendation and a final decision on the Marketing Authorization Application is expected to be available in approximately...