FDA approves two new indications for Xarelto (rivaroxaban) in paediatric patients
In the US rivaroxaban is now licensed for treatment of venous thromboembolism (VTE) and recurrent VTE prevention in patients from birth to <18yrs post 5 days parenteral anticoagulation and thromboprophylaxis aged ≥2yrs with congenital heart disease & undergone Fontan procedure.
Source:
Biospace Inc.
SPS commentary:
In the UK, rivaroxaban (Xarelto) 1mg/ml granules for oral suspension is not currently licensed for treatment children with congenital heart disease who have undergone Fontan procedure.