risperidone

Details

Generic Name:
risperidone
Project Status:
Active
Therapeutic Area:
Schizophrenia, adults
Manufacturer:
Teva Canada Innovation
Call for patient/clinician input open:
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
SR0811-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of schizophrenia in adults.
Submission Type:
Initial
Submission Complexity:
Tailored Review
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 openAugust 30, 2023
Call for patient/clinician input closedOctober 24, 2023
Clarification:

- No patient input submission received

Submission receivedOctober 13, 2023
Submission acceptedOctober 27, 2023
Review initiatedOctober 30, 2023
Draft CADTH review report(s) provided to sponsor for commentFebruary 01, 2024
Deadline for sponsors commentsFebruary 12, 2024
Clarification:

- Submission temporarily suspended

- Additional information has been received and the temporary suspension of the review has been lifted

CDA-AMC review report(s) and responses to comments provided to sponsorJune 13, 2025
Expert committee meeting (initial)June 25, 2025
Draft recommendation issued to sponsorJuly 08, 2025
To
July 10, 2025
Draft recommendation posted for stakeholder feedbackJuly 17, 2025
End of feedback periodJuly 31, 2025