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CSL Behring Announces Completion of National Marketing Authorizations of Berinert® After MRP in 23 European Countries
Date:5/27/2010

MILAN, May 27 /PRNewswire/ -- CSL Behring announced today it has been granted national marketing authorization in Italy and Luxembourg to market Berinert® for the treatment of acute hereditary angioedema (HAE) attacks in any body location. This latest authorization brings the number of countries to 28 (in Europe, Asia, North America, South America and Australia) in which Berinert is now licensed.

In October 2009, the United States Food and Drug Administration approved Berinert for the treatment of acute abdominal and facial attacks of HAE, a rare and serious genetic disorder, in adolescent and adult patients. CSL Behring completed the European Mutual Recognition Procedure (MRP) for Berinert in 23 countries in December, 2008. Marketing authorization was also granted for Australia in January, 2010, and applications for licensing in Canada and Israel have also been filed with authorities. 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 Multi-center Prospective Angioedema C1-Inhibitor Trial (I.M.P.A.C.T.), the largest single p
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SOURCE CSL Behring
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