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Inpharma 1659 - 11 Oct 2008 Rivaroxaban approved for marketing in the EU Rivaroxaban [Xarelto], a novel, oral, once-daily anticoagulant, developed by Bayer HealthCare and Johnson & Johnson Pharmaceutical Research & Development, has been granted marketing approval by the European Commission. This product is indicated to prevent venous blood clots in adults undergoing elective hip or knee replacement surgery. Bayer HealthCare plans to launch rivaroxaban in the EU member states in the near future. The EU approval of rivaroxaban comes soon after the world-first approval of the drug in Canada for use in the prevention of venous thromboembolic events in adults who have undergone elective total hip or knee joint replacement surgery. Submissions to regulatory agencies regarding rivaroxaban are being reviewed in more than ten other countries including the US. Bayer Schering Pharma. Bayer’s Novel Anticoagulant Xarelto (Rm) now also Approved in the EU. Media Release : 1 Oct 2008. Available from: URL: http:// www.bayerscheringpharma.de 809093693 1 Inpharma 11 Oct 2008 No. 1659 1173-8324/10/1659-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

Rivaroxaban approved for marketing in the EU

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Inpharma 1659 - 11 Oct 2008

Rivaroxaban approved formarketing in the EU

Rivaroxaban [Xarelto], a novel, oral, once-dailyanticoagulant, developed by Bayer HealthCare andJohnson & Johnson Pharmaceutical Research &Development, has been granted marketing approval bythe European Commission. This product is indicated toprevent venous blood clots in adults undergoing electivehip or knee replacement surgery. Bayer HealthCareplans to launch rivaroxaban in the EU member states inthe near future.

The EU approval of rivaroxaban comes soon after theworld-first approval of the drug in Canada for use in theprevention of venous thromboembolic events in adultswho have undergone elective total hip or knee jointreplacement surgery. Submissions to regulatoryagencies regarding rivaroxaban are being reviewed inmore than ten other countries including the US.Bayer Schering Pharma. Bayer’s Novel Anticoagulant Xarelto (Rm) now alsoApproved in the EU. Media Release : 1 Oct 2008. Available from: URL: http://www.bayerscheringpharma.de 809093693

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Inpharma 11 Oct 2008 No. 16591173-8324/10/1659-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved