European Commission approves the commercialization of the novel estetrol and drospirenone containing oral contraceptive.

Budapest, Hungary – 20 May 2021 – Gedeon Richter Plc. (“Richter”) announces that the European Commission (“EC”) has granted approval for the marketing authorization of the novel combined oral contraceptive containing 15 mg estetrol (“E4”) and 3 mg drospirenone (“DRSP”). This decision followed a positive opinion from the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) on 26 March 2021 and is applicable for all Member States in the European Union. The product will be marketed in Europe by Richter under the brand name Drovelis ®.