Budapest, Hungary – 19 May 2017 – 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 on the company’s application for cariprazine, a novel antipsychotic for the treatment of schizophrenia in adult patients.
The marketing au-thorization application has been submitted to EMA in March 2016. Subject to approval by the European Commission, Richter is expected to receive in two months a marketing authoriza-tion for cariprazine valid for all European Union Member States.