Reason for request
Favourable opinion for maintenance of reimbursement in the MA indications.
Role in the care pathway?
The role of XARELTO (rivaroxaban) in the care pathway remains unchanged for all its indications.
In the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrences, the Committee considers that XARELTO (rivaroxaban) still has no role in patients with active cancer, including in patients at low haemorrhagic risk, due to a lack of sufficient clinical data.
The Committee deems that the clinical benefit of XARELTO (rivaroxaban) remains substantial in: