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ulipristal acetate

Last Updated: May 16, 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
Clarification:

- Patient input submission received from CANFib (Canadian Women with Fibroids Incorporated) and the Women’s Health Initiative Network

Patient input summary sent for review to patient input groupsMay 14, 2019
Patient group comments on input summary closedMay 21, 2019
Clarification:

- Patient input summary feedback received

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 09, 2019
Comments from manufacturer on draft CDR Request for Advice report receivedMay 21, 2019
Redaction requests from manufacturer on draft CDR Request for Advice report receivedMay 28, 2019
Canadian Drug Expert Committee (CDEC) meetingJune 19, 2019