Omrix Biopharmaceuticals, Inc, a fully-integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, has received approval from the European Medicines Agency (EMEA) for Evicel, the company's liquid fibrin sealant.
The EMEA's approval permits Evicel to be marketed in Europe under the indication of, "As a supportive treatment in surgery where standard surgical techniques are insufficient for improvement of haemostasis. Evicel is also indicated as suture support for haemostasis in vascular surgery."
Evicel is currently marketed in the US by Johnson & Johnson Wound Management, a division of Ethicon, INC, a Johnson & Johnson company, with a general haemostasis in surgery indication.
With an EMEA approval, Evicel is licensed for marketing in the 27 countries of the European Union, or EU. Per the terms of Omrix' and Ethicon's supply and distribution agreement, Ethicon has the marketing rights for the EU.
Evicel is an all-human, plasma-derived fibrin sealant currently indicated in the US as an adjunct to haemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques is ineffective or impractical.
Omrix is a fully integrated biopharmaceutical company that develops, manufactures and markets protein-based biosurgery and passive immunotherapy products.