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sofosbuvir velpatasvir voxilaprevir

Last Updated: April 4, 2018
Result type: Reports
Project Number: SR0529-000
Product Line: Common Drug Review

Generic Name: sofosbuvir velpatasvir voxilaprevir

Brand Name: Vosevi

Manufacturer: Gilead Sciences Canada, Inc.

Indications: Hepatitis C, chronic

Submission Type: New Combination

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 postedJuly 07, 2017
Patient group input closedAugust 28, 2017
Clarification:

Patient input submission received

Patient input summary sent for review to patient input groupsAugust 30, 2017
Patient group comments on input summary closedSeptember 07, 2017
Clarification:

- Patient input summary feedback received

Submission receivedJuly 28, 2017
Submission accepted for reviewAugust 14, 2017
Review initiatedAugust 15, 2017
Draft CDR review report(s) sent to applicantOctober 30, 2017
Comments from applicant on draft CDR review report(s) receivedNovember 08, 2017
Redaction requests from applicant on draft CDR review report(s) receivedNovember 15, 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 07, 2018

Tags

hepatitis, hepatitis c, sofosbuvir; velpatasvir; voxilaprevir