Last Updated : November 13, 2024
Details
FilesGeneric Name:
garadacimab
Project Status:
Active
Therapeutic Area:
Hereditary angioedema (HAE)
Manufacturer:
CSL Behring Canada Inc.
Call for patient/clinician input open:
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
SR0860-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Routine prevention of attacks of hereditary angioedema
(HAE) in adult and pediatric patients (aged 12 years and older).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Routine prevention of attacks of hereditary angioedema
(HAE) in adult and pediatric patients (aged 12 years and older).
- 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 | 10-Jun-24 |
|---|---|
| Call for patient/clinician input closed | 02-Aug-24 |
| Submission received | 31-Jul-24 |
| Submission accepted | - |
| Review initiated | 16-Aug-24 |
| Draft CADTH review report(s) provided to sponsor for comment | 01-Nov-24 |
| Deadline for sponsors comments | 13-Nov-24 |
| CADTH review report(s) and responses to comments provided to sponsor | 06-Dec-24 |
| Expert committee meeting (initial) | 18-Dec-24 |
| Draft recommendation issued to sponsor | January 07, 2025 To January 09, 2025 |
| Draft recommendation posted for stakeholder feedback | 16-Jan-25 |
| End of feedback period | 31-Jan-25 |
Files
Last Updated : November 13, 2024