Last Updated : October 29, 2024
Details
FilesGeneric Name:
crovalimab
Project Status:
Active
Therapeutic Area:
paroxysmal nocturnal hemoglobinuria (PNH)
Manufacturer:
Hoffmann-La Roche Limited
Call for patient/clinician input open:
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
SR0858-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Crovalimab is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Crovalimab is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH).
- 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.
Call for patient/clinician input open | 19-Aug-24 |
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Call for patient/clinician input closed | 15-Oct-24 |
Submission received | 01-Oct-24 |
Submission accepted | 16-Oct-24 |
Review initiated | 17-Oct-24 |
Draft CADTH review report(s) provided to sponsor for comment | 08-Jan-25 |
Deadline for sponsors comments | 17-Jan-25 |
CADTH review report(s) and responses to comments provided to sponsor | 13-Feb-25 |
Expert committee meeting (initial) | 26-Feb-25 |
Draft recommendation issued to sponsor | - |
Draft recommendation posted for stakeholder feedback | - |
End of feedback period | - |
Files
Last Updated : October 29, 2024