Richter and Mithra received positive CHMP opinion for a novel estetrol and drospirenone containing oral contraceptive.

Budapest, Hungary – Liège, Belgium – 26 March 2021 – Gedeon Richter Plc. (“Richter”) and Mithra Pharmaceuticals (“Mithra”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for a novel combined oral contraceptive containing 15 mg estetrol (E4) and 3 mg drospirenone (DRSP). Subject to approval by the European Commission, the marketing authorization valid for all European Union Member States is expected to be granted by the end of the second quarter 2021. The product will be marketed in Europe by...