Bayer submits application to EMA for use of rivaroxaban in children with venous thromboembolism (for specialized target groups only)

Adding treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children from birth to 17 years of age with confirmed VTE, including cerebral vein and sinus thrombosis / Submission based on results from phase 3 EINSTEIN-Jr. study showing convincing efficacy and safety profile for rivaroxaban in children with VTE / An oral liquid formulation of rivaroxaban that does not require injections and regular monitoring was developed to facilitate pediatric administration / Patent extension in Europe of six months will be applied for once the procedure is completed
Source: Bayer Company News - Category: Pharmaceuticals Source Type: news