risperidone

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Generic Name:
risperidone
Project Status:
Active
Therapeutic Area:
Schizophrenia, adults
Manufacturer:
Bausch Health, Canada Inc.
Call for patient/clinician input open:
Brand Name:
Okedi
Project Line:
Reimbursement Review
Project Number:
SR0879-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of schizophrenia in adults.
Submission Type:
Initial
Fee Schedule:
Schedule C
Indications:
​For the treatment of schizophrenia in adults.
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
Key Milestones2
Call for patient/clinician input openFebruary 06, 2025
Call for patient/clinician input closedMarch 31, 2025
Submission receivedMarch 21, 2025
Submission acceptedApril 04, 2025
Review initiatedApril 07, 2025
Draft CADTH review report(s) provided to sponsor for commentJune 23, 2025
Deadline for sponsors commentsJuly 03, 2025
CDA-AMC review report(s) and responses to comments provided to sponsorAugust 15, 2025
Expert committee meeting (initial)August 27, 2025
Draft recommendation issued to sponsorSeptember 09, 2025
To
September 11, 2025
Draft recommendation posted for stakeholder feedbackSeptember 18, 2025
End of feedback periodOctober 03, 2025