Last Updated : February 21, 2025
Details
FilesGeneric Name:
relugolix, estradiol, and norethindrone acetate
Project Status:
Active
Therapeutic Area:
Management of heavy menstrual bleeding associated with uterine fibroids
Manufacturer:
Pfizer Canada ULC and Sumitomo Pharma Switzerland GmbH
Call for patient/clinician input open:
Brand Name:
Myfembree
Project Line:
Reimbursement Review
Project Number:
SR0885-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
- 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 | December 16, 2024 |
|---|---|
| Call for patient/clinician input closed | February 18, 2025 |
| Submission received | February 04, 2025 |
| Submission accepted | February 19, 2025 |
| Review initiated | February 20, 2025 |
| Draft CADTH review report(s) provided to sponsor for comment | May 08, 2025 |
| Deadline for sponsors comments | May 20, 2025 |
| CADTH review report(s) and responses to comments provided to sponsor | June 13, 2025 |
| Expert committee meeting (initial) | June 25, 2025 |
| Draft recommendation issued to sponsor | July 08, 2025 To July 10, 2025 |
| Draft recommendation posted for stakeholder feedback | July 17, 2025 |
| End of feedback period | July 31, 2025 |
Files
Last Updated : February 21, 2025