Omrix Biopharmaceuticals has received approval from the European Medicines Agency for Evicel, the company's liquid fibrin sealant.
Omrix said that the European Medicines Agency's (EMEA's) approval permits Evicel to be marketed in Europe under the following indication: "As a supportive treatment in surgery where standard surgical techniques are insufficient for improvement of hemostasis. Evicel is also indicated as suture support for hemostasis in vascular surgery."
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. With an EMEA approval, Evicel is licensed for marketing in the 27 countries of the EU. Per the terms of Omrix's and Ethicon's supply and distribution agreement, Ethicon has the marketing rights for the EU.