Omrix Biopharmaceuticals Receives Positive Opinion from Committee for Medicinal Products for...

yahoo.com     Jul 25, 2008            

NEW YORK--(BUSINESS WIRE)--OMRIX Biopharmaceuticals, Inc. (“Omrix” or the “Company”) (NASDAQ: OMRI - News ), a fully-integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, announced today that it has received a positive opinion for EVICEL™ Fibrin Sealant (Human) from the Committee for Medicinal Products for Human Use (CHMP). Omrix is seeking approval to market Evicel in Europe for the improvement of hemostasis in surgery. CHMP is the scientific committee of the European Medicines Agency (EMEA) and is responsible for reviewing medicinal product applications for quality, safety and efficacy. The CHMP's positive opinion for Evicel will now be forwarded to the European Commission for marketing authorization, which is expected by the end of the third quarter of 2008 (3Q08). The... [read full story]                    

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