XARELTO (Bayer Australia Ltd)
Product name
XARELTO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
87 (255 working days)
Active ingredients
Rivaroxaban
Registration type
EOI
Indication
XARELTO granules for oral suspension (1 mg/mL) is indicated for:
- Treatment of VTE and prevention of VTE recurrence in term neonates, infants and toddlers, children, and adolescents aged less than 18 years after at least 5 days of initial parenteral anticoagulation treatment.