LEVERKUSEN (dpa-AFX) - Bayer (BAYZF.PK, BAYRY.PK, BYR.L) said Monday that the U.K. has approved the use of its oral Factor Xa inhibitor Xarelto or rivaroxaban to treat venous thromboembolism or VTE and to prevent VTE recurrence in children from birth to below 18 years after at least 5 days of initial parenteral anticoagulation treatment.
Paediatric VTE includes cerebral vein and sinus thrombosis (a blood clot in the brain), central venous catheter related thrombosis, pulmonary embolism (a blood clot that travels to the lung), and deep vein thrombosis (a blood clot in a deep vein).
The U.K. has also approved the use of a new formulation and strength granules for oral suspension 1mg/ml.
The approval follows a positive opinion from the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency in November 2020, which recommended approval in the European Union. The CHMP recommendation and approval also apply to the UK.
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