Last Updated : November 6, 2019
Details
FilesGeneric Name:
ulipristal acetate
Project Status:
Complete
Therapeutic Area:
Uterine fibroids (signs and symptoms)
Manufacturer:
Allergan Canada Inc.
Call for patient/clinician input open:
Brand Name:
Fibristal
Project Line:
Reimbursement Review
Project Number:
SF0528-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Submission Type:
Request For Advice
Indications:
Uterine fibroids (signs and symptoms)
Date NOC Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
Key Milestones1 |
|
|---|---|
| Call for patient input posted | June 21, 2017 |
| Patient group input closed | July 26, 2017 |
| Clarification:
- Patient input submission received |
|
| Patient input summary sent for review to patient input groups | August 17, 2017 |
| Patient group comments on input summary closed | August 24, 2017 |
| Clarification:
- Patient input summary feedback received |
|
| Request for Advice received | June 21, 2017 |
| Manufacturer informed of request for advice | June 21, 2017 |
| Manufacturer information or comments due | July 06, 2017 |
| Request for Advice initiated | June 26, 2017 |
| Draft CDR Request for Advice report sent to manufacturer | August 30, 2017 |
| Comments from manufacturer on draft CDR Request for Advice report received | September 11, 2017 |
| Redaction requests from manufacturer on draft CDR Request for Advice report received | September 18, 2017 |
| CDR review team's comments on draft CDR Request for Advice report sent to manufacturer | October 05, 2017 |
| Canadian Drug Expert Committee (CDEC) meeting | October 18, 2017 |
| CDEC recommendation & redacted CDR Request for Advice report sent to manufacturer and drug plans | November 01, 2017 |
| Embargo period ended and validation of redacted CDR Request for Advice report received | November 15, 2017 |
| Final CDR Request for Advice report and patient input posted | December 15, 2017 |
Files
Last Updated : November 6, 2019