Richter receives positive feedback for new contraceptive
Hungarian pharmaceutical company Gedeon Richter and Belgian peer Mithra Pharmaceuticals have said the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for a new combined oral contraceptive containing 15 mg estetrol (E4) and 3mg drospirenone (DRSP), according to an announcement on the website of the Budapest Stock Exchange.
Subject to approval by the European Commission, the marketing authorization valid for the European Union is expected to be granted by the end of Q2 2021, the companies said.
Richter will market the product in Europe under the brand name Drovelis. The company announced a partnership with Mithra in September 2018 to sell the oral contraceptive in Europe, Russia and other CIS countries under a different brand name. Mithra sells the contraceptive under the Estelle brand.
Oral contraceptives are Richter's top-selling products.
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