Bayer HealthCare’s oral anticoagulant Xarelto (rivaroxaban) has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for both the prevention of Stroke and systemic embolism in adults with non-valvular Atrial Fibrillation (AF), as well as for the treatment of Deep Vein Thrombosis (DVT) and prevention of recurrent DVT and Pulmonary Embolism (PE) following an acute DVT in adults. The decision of the European Commission is expected in the fourth quarter 2011. The recommendation to approve Xarelto for stroke prevention in Atrial Fibrillation is based on clinical benefits demonstrated in ROCKET AF study. The recommendation for the treatment of DVT and the prevention of recurrent DVT and PE following an acute DVT, follows data from the Phase III EINSTEIN-DVT and EINSTEIN-extension studies.
CHMP recommends Xarelto (Bayer) for the treatment of Pulmonary Embolism and the prevention of recurrent Deep Vein Thrombosis and Pulmonary Embolism in adults.
25-hydroxyvitamin D concentrations and risk of venous thromboembolism in the general population with 18,791 participantsJournal of Thrombosis and Haemostasis 29 December 2012
- WARFARIN TABLETS 5MG B.P.
- CLEXANE FORTE SYRINGES
- RAPILYSIN 10 U POWDER AND SOLVENT FOR SOLUTION FOR INJECTION.
- XARELTO 10 MG FILM-COATED TABLETS
- INNOHEP 20,000 IU/ML AND INNOHEP SYRINGE 20,000 IU/ML
- MAREVAN 0.5MG TABLETS
- WARFARIN TABLETS 1MG
- PRADAXA 110 MG HARD CAPSULES
- ARIXTRA 2.5MG/0.5ML SOLUTION FOR INJECTION, PRE-FILLED SYRINGE
- PHENINDIONE 50MG TABLETS
- PHENINDIONE 10MG TABLETS
- XARELTO 20MG FILM-COATED TABLETS
- HEPARIN SODIUM 25,000 I.U./ML SOLUTION FOR INJECTION OR CONCENTRATE FOR SOLUTION FOR INFUSION(WITHOUT PRESERVATIVE)
- PHENINDIONE 25MG TABLETS
- ELIQUIS 2.5 MG FILM-COATED TABLETS
- ANGIOX 250MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION OR INFUSION
- PRADAXA 150 MG HARD CAPSULES
- CLEXANE PRE-FILLED SYRINGES
- PRADAXA 75 MG HARD CAPSULES
- UROKINASE 10,000 I.U.
- XARELTO 15MG FILM-COATED TABLETS
- WARFARIN TABLETS 3MG B.P.
- ARIXTRA 5MG, 7.5MG, 10MG SOLUTION FOR INJECTION, PRE-FILLED SYRINGE
- MAREVAN 1MG TABLETS
- ELIQUIS 5 MG FILM-COATED TABLETS