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EMA accepts regulatory submission for Richter’s combined oral contraceptive

Pharmaceutical company Gedeon Richter today announced that the European Medicines Agency (EMA) has accepted Richter’s regulatory submission for a combined oral contraceptive, containing estetrol (E4) and drospirenone. 


The product is considered a novel oral contraceptive with natural, native estrogen acting selectively in tissues, according to a press release by the company.

According to the relevant license agreement, Richter is going to commercialize the product in Europe, Russia, and other CIS countries.

The novel oral contraceptive, developed by Mithra, is a product candidate composed of 15 mg estetrol (E4), a unique native estrogen and 3 mg drospirenone.