Canada’s Drug Agency | Drugs, Health Technologies and Systems.

relugolix, estradiol, and norethindrone acetate

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Generic 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.
  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 open16-Dec-24
Call for patient/clinician input closed18-Feb-25
Submission received04-Feb-25
Submission accepted19-Feb-25
Review initiated20-Feb-25
Draft CADTH review report(s) provided to sponsor for comment08-May-25
Deadline for sponsors comments20-May-25
CDA-AMC review report(s) and responses to comments provided to sponsor13-Jun-25
Expert committee meeting (initial)25-Jun-25
Draft recommendation issued to sponsorJuly 08, 2025
To
July 10, 2025
Draft recommendation posted for stakeholder feedback17-Jul-25
End of feedback period31-Jul-25

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Patient and Clinician Group Input View PDF
Last Updated : April 11, 2025