Budapest, Hungary – Basel, Switzerland / Cambridge, Mass., USA – 2 November 2023 – Gedeon Richter Plc. (‘Richter’) together with Sumitomo Pharma America, Inc. (‘SMPA’) and Sumitomo Pharma Switzerland, GmbH (‘SMPS’) today announce that the European Commission (‘EC’) has granted approval of a Type II Variation application for Ryeqo® (relugolix 40 mg, estradiol 1.0 mg, and norethisterone acetate 0.5 mg) for the symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis. This decision followed a positive opinion from the Committee for Medicinal Products for Human Use (‘CHMP’) of the European Medicines Agency (‘EMA’) on 15 September 2023 and is applicable for all Member States in the European Union.

Budapest, Hungary – Basel, Switzerland / Cambridge, Mass., USA – 15 September 2023 – Gedeon Richter Plc. (‘Richter’) together with Sumitomo Pharma America, Inc. (‘SMPA’) and Sumitomo Pharma Switzerland (‘SMPS’) today announce that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) has adopted a positive opinion recommending the approval of a Type II Variation application for Ryeqo® (relugolix 40 mg, estradiol 1.0 mg, and norethisterone acetate 0.5 mg) for the symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis.

Gedeon Richter Plc. today announced that it has submitted a Type II Variation application for Ryeqo® (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) to the European Medicines Agency (EMA) for the treatment of moderate to severe pain associated with endometriosis in adult women of reproductive age with a history of previous medical or surgical treatment for their endometriosis. Ryeqo® is already approved by the EMA for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age since July 2021.