A defective INR device used to monitor blood clotting in the main study supporting the 2011 approval of Bayer AG's new oral anticoagulant Xarelto (rivaroxaban) in stroke prevention in atrial fibrillation had no effect on the safety and benefit/risk balance of the product, the EMA has concluded. Xarelto can continue to be used as before, in line with the current prescribing information, it said.
Bayer's Xarelto 'Safe' Despite ROCKET Device Defect
A defective INR device used to monitor blood clotting in the main study supporting the 2011 approval of Bayer AG's new oral anticoagulant Xarelto (rivaroxaban) in stroke prevention in atrial fibrillation had no effect on the safety and benefit/risk balance of the product, the EMA has concluded. Xarelto can continue to be used as before, in line with the current prescribing information, it said.
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