European Commission approves Esmya® for the pre-operative treatment of uterine fibroids (myomas)

European Commission approves Esmya® for the pre-operative treatment of uterine fibroids (myomas)

Gedeon Richter Plc. (“Richter”) announces today that the European Commission (EC) has granted marketing authorization to Esmya® 5mg tablet as pre-operative treatment of moderate to severe symptoms of uterine fibroids. This decision follows positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on 16 December 2011 and is applicable for all Member States in the European Union.

PEARL I and II studies published in New England Journal of Medicine confirm the efficacy of Esmya® (ulipristal acetate) for the pre-operative treatment of uterine fibroids (myomas)

PEARL I and II studies published in New England Journal of Medicine confirm the efficacy of Esmya® (ulipristal acetate) for the pre-operative treatment of uterine fibroids (myomas)

Geneva, Switzerland – 2 February 2012 – PregLem, the wholly owned subsidiary of Gedeon Richter, announces full results of PEARL I and II studies, published simultaneously in the New England Journal of Medicine (NEJM). The company has recently received positive EMA/CHMP opinion for Esmya® 5 mg (ulipristal acetate) in the pre-operative treatment of uterine fibroids (myomas) and is expecting a marketing authorization by the European Commission early this year.

Richter announces that PregLem, its wholly owned subsidiary, receives positive EMA/CHMP opinion for Esmya® for the pre-operative treatment of uterine fibroids (myomas)

Richter announces that PregLem, its wholly owned subsidiary, receives positive EMA/CHMP opinion for Esmya® for the pre-operative treatment of uterine fibroids (myomas)

Gedeon Richter Plc. (“Richter”) announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Esmya® 5mg tablet as pre-operative treatment of moderate to severe symptoms of uterine fibroids. Subject to approval by the European Commission, PregLem, the wholly owned subsidiary of Richter, is expected to receive in early 2012, a marketing authorization for Esmya® valid for all European Union Member States.