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glecaprevir pibrentasvir

Last Updated: April 11, 2018
Result type: Reports
Project Number: SR0523-000
Product Line: Common Drug Review

Generic Name: glecaprevir pibrentasvir

Brand Name: Maviret

Manufacturer: AbbVie Corporation

Indications: Hepatitis C, chronic

Submission Type: New

Project Status: Complete

Biosimilar: No

Date Recommendation Issued: January 23, 2018

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule: Schedule A

Key Milestones2

Call for patient input postedMay 11, 2017
Patient group input closedJune 30, 2017
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsJuly 19, 2017
Patient group comments on input summary closedJuly 26, 2017
Clarification:

- Patient input summary feedback received

Submission receivedJune 09, 2017
Submission accepted for reviewJune 23, 2017
Review initiatedJune 26, 2017
Draft CDR review report(s) sent to applicantSeptember 28, 2017
Comments from applicant on draft CDR review report(s) receivedOctober 10, 2017
Redaction requests from applicant on draft CDR review report(s) receivedOctober 17, 2017
CDR review team's comments on draft CDR review report(s) sent to applicantDecember 01, 2017
Canadian Drug Expert Committee (CDEC) meetingDecember 13, 2017
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansJanuary 02, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedJanuary 16, 2018
CDEC Final Recommendation issued to applicant and drug plansJanuary 23, 2018
CDEC Final Recommendation postedJanuary 25, 2018
Final CDR review report(s) and patient input postedFebruary 08, 2018

Tags

hepatitis, hepatitis c, chronic, maviret; glecaprevir/pibrentasvir; mavyret