Berinert P in Romania

In 2009, CSL Behring GmbH, Germany, has been granted authorization to market Berinert P in Romania for the treatment of acute hereditary angioedema attacks. Berinert P is a purified, virus-inactivated, human plasma-derived C1 inhibitor concentrate. Berinert is now licensed in 28 countries around the world including many European countries. CSL Behring completed the European Mutual Recognition Procedure (MRP) for Berinert in 23 countries in December, 2008. Marketing authorization was also granted for USA in november 2009 and Australia in January, 2010. Berinert has been marketed in Germany for more than 30 years. The approvals are mainly based on the results of the phase II/III prospective, double-blind placebo-controlled International Angioedema C1-Inhibitor Trial (I.M.P.A.C.T.). In Romania, the therapeutic agent is sold under the name Berinert P.