Posted by Michael Wonder on 02 Feb 2021
Bayer receives approval in the UK for Xarelto (rivaroxaban) to treat children with venous thromboembolism and to prevent recurrence
1 February 2021 - Paediatric use of rivaroxaban is based on data from the phase III paediatric thromboembolism programme, EINSTEIN-Junior.
Bayer has received approval for the use of its oral Factor Xa inhibitor Xarelto (rivaroxaban) to treat venous thromboembolism and to prevent the recurrence of venous thromboembolism in children from birth to below 18 years after at least 5 days of initial parenteral anticoagulation treatment, including catheter related thrombosis, cerebral vein and sinus thrombosis.
The use of a new formulation and strength 1 mg/mL granules for oral suspension was also approved.
