CHMP recommends Richter Drovelis a new combined contraceptive. Gedeon Richter.

Richter Gedeon Plc. and Mithra Pharmaceuticals announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a favorable opinion on 15 mg estetrol (E4) and 3 mg drospirenone (DRSP) for a new combined contraceptive. Subject to a decision by the European Commission, Richter and Mithra are expected to receive marketing authorizations for all EU Member States by the end of the second quarter of 2021. The product will be marketed under the brand name Richter Drovelis. Estetrol is a new chemically synthesised oestrogen, which in humans is produced only by the liver of the human foetus during pregnancy and reaches the maternal circulation through the placenta. Estetrol suppresses follicle stimulating hormone activity and stabilises the bleeding pattern. Drospirenone is a previously known progestogen, which suppresses luteinizing hormone activity. These actions result in a contraceptive effect which is based on the interaction of various factors, the most important of which is inhibition of ovulation.