Drug news
EMA CHMP recommends approval of two generics to Procoralan: Ivabradine JensonR and Ivabradine Zentiva for chronic heart failure and symptomatic treatment of chronic stable angina pectoris - JensonR+ and Zentiva
The EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for two medicinal products: Ivabradine JensonR, from JensonR+, and Ivabradine Zentiva, from Zentiva, intended for the treatment of chronic heart failure and symptomatic treatment of chronic stable angina pectoris. Ivabradine JensonR and Ivabradine Zentiva are both generics of Procoralan, which has been authorised in the EU since the 25 October 2005. Studies have demonstrated the satisfactory quality of both drugs and their bioequivalence to the reference product Procoralan.