Quote this publication Share Print

XARELTO (rivaroxaban), oral anticoagulant

Opinions on drugs - Posted on Jan 13 2017

Reason for request

Re-assessment of the actual benefit and the improvement in actual benefit

No clinical advantage demonstrated in prolonged treatment beyond 12 months in prevention of recurrences of pulmonary embolism and deep vein thrombosis in adults


  • XARELTO (15 mg and 20 mg) has a Marketing Authorisation in the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrences as DVT and PE in adults.
  • Its effectiveness is not inferior to that of enoxaparin followed by warfarin and its risk of bleeding is similar up to 12 months of treatment.
  • Its benefit in the long-term prevention of recurrences beyond 12 months and for up to 2 years was evaluated versus placebo. The selection criteria for patients who may benefit from this strategy cannot be clearly defined and the decision must be made on a case-by-case basis.



Clinical Benefit



Clinical Added Value

no clinical added value


Therapeutic use


Contact Us

Évaluation des médicaments