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ulipristal acetate

Last Updated: April 17, 2019
Result type: Reports
Project Number: SF0609-000
Product Line: Common Drug Review

Generic Name: ulipristal acetate

Brand Name: Fibristal

Manufacturer: Allergan Inc.

Indications: Uterine fibroids (signs and symptoms)

Submission Type: Request For Advice

Project Status: Active

Biosimilar: No

Companion Diagnostics: No

Key Milestones1

Call for patient input postedMarch 29, 2019
Patient group input closedMay 21, 2019
Patient input summary sent for review to patient input groups-
Patient group comments on input summary closed-
Request for Advice receivedMarch 28, 2019
Manufacturer informed of request for adviceMarch 28, 2019
Manufacturer information or comments dueApril 11, 2019
Request for Advice initiatedApril 12, 2019
Draft CDR Request for Advice report sent to manufacturerMay 07, 2019
Comments from manufacturer on draft CDR Request for Advice report receivedMay 16, 2019
Redaction requests from manufacturer on draft CDR Request for Advice report receivedMay 24, 2019
CDR review team's comments on draft CDR Request for Advice report sent to manufacturerJune 07, 2019
Canadian Drug Expert Committee (CDEC) meetingJune 19, 2019
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