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news.Omrix Biopharmaceuticals has received a positive opinion for Evicel fibrin sealant from the Committee for Medicinal Products for Human Use. Omrix is seeking approval to market Evicel in Europe for the improvement of hemostasis in surgery.
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The Committee for Medicinal Products for Human Use’s (CHMP) 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.
Omrix’s Evicel is currently marketed in the US by Johnson & Johnson Wound Management, a division of Ethicon, a Johnson & Johnson company, with a general hemostasis in surgery indication.
Upon its anticipated approval, Evicel will be licensed for marketing in the 27 countries of the EU. Per the terms of Omrix and Ethicon’s supply and distribution agreement, Ethicon has the marketing rights for the EU.