rivaroxaban


( Last Updated : March 2, 2023)
Generic Name:
rivaroxaban
Project Status:
Active
Therapeutic Area:
Venous thromboembolic events (VTE)
Manufacturer:
N/A
Call for patient/clinician input open:
Brand Name:
N/A
Project Line:
Reimbursement Review
Project Number:
SX0750-000 - SR0750-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC

Details


Submission Type:
Non-sponsored Submission
Indications:
Treatment of venous thromboembolic events (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.

Key Milestones

Call for patient/clinician input open 14-Juj-22
Call for patient/clinician input closed 02-Sep-22
Clarification:

- No patient input submission received

Call for Industry feedback open 14-Jul-22
Call for industry feedback closed 02-Sep-22
Review initiated 12-Oct-22
Expert Committee Meeting (Initial)
Clarification:

- Expert committee meeting date to be determined

Draft recommendation posted for stakeholder feedback
End of Feedback Period