Gedeon Richter Plc. announces that the European Commission (EC) has granted approval for the intermittent use of Esmya 5 mg in the long term management of uterine fibroids. This decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on 23 April 2015 and is applicable for all Member States in the European Economic Area.

The initial Marketing Authorization for Esmya was granted for the pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. The present extension of indication adding the intermittent treatment courses of Esmya provides an opportunity to women to benefit from long term medical management of uterine fibroids and potentially avoid surgery.

For more details, go to: https://www.richter.hu/en-US/pressroom/press-release/Pages/press-releases/pr150528.aspx