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ulipristal acetate

Last Updated: February 9, 2018
Result type: Reports
Project Number: SF0528-000
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: Complete

Biosimilar: No

Date Recommendation Issued: November 22, 2017

Recommendation Type: Reimburse with clinical criteria and/or conditions

Key Milestones1

Call for patient input posted2June 21, 2017
Patient group input closed2July 26, 2017
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsAugust 17, 2017
Patient group comments on input summary closedAugust 24, 2017
Clarification:

- Patient input summary feedback received

Request for Advice receivedJune 21, 2017
Manufacturer informed of request for adviceJune 21, 2017
Manufacturer information or comments dueJuly 06, 2017
Request for Advice initiatedJune 26, 2017
Draft CDR Request for Advice report sent to applicantAugust 30, 2017
Comments from applicant on draft CDR Request for Advice report receivedSeptember 11, 2017
Redaction requests from applicant on draft CDR Request for Advice report receivedSeptember 18, 2017
CDR review team's comments on draft CDR Request for Advice report sent to applicantOctober 05, 2017
Canadian Drug Expert Committee (CDEC) meeting3October 18, 2017
CDEC recommendation & redacted CDR Request for Advice report sent to applicant and drug plansNovember 01, 2017
Embargo4 period ended and validation of redacted CDR Request for Advice report receivedNovember 15, 2017
CDEC Final Recommendation issued to applicant and drug plansNovember 22, 2017
CDEC Final Recommendation posted5November 24, 2017
Final CDR Request for Advice report and patient input posted5December 15, 2017

Tags

gynecology/obstetrics, ulipristal; Esmya; Fibristal; Uterine; fibroid; fibroids