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tenofovir alafenamide

Last Updated: April 30, 2018
Result type: Reports
Project Number: SR0537-000
Product Line: Common Drug Review

Generic Name: tenofovir alafenamide

Brand Name: Vemlidy

Manufacturer: Gilead Sciences Canada, Inc.

Indications: Hepatitis B, chronic

Submission Type: New

Project Status: Complete

Biosimilar: No

Date Recommendation Issued: March 26, 2018

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule: Schedule A

Key Milestones2

Call for patient input postedAugust 30, 2017
Patient group input closedOctober 20, 2017
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsNovember 02, 2017
Patient group comments on input summary closedNovember 09, 2017
Clarification:

- Patient input summary feedback received

Submission receivedSeptember 28, 2017
Submission accepted for reviewOctober 13, 2017
Review initiatedOctober 16, 2017
Draft CDR review report(s) sent to applicantJanuary 04, 2018
Comments from applicant on draft CDR review report(s) receivedJanuary 15, 2018
Redaction requests from applicant on draft CDR review report(s) receivedJanuary 22, 2018
CDR review team's comments on draft CDR review report(s) sent to applicantFebruary 08, 2018
Canadian Drug Expert Committee (CDEC) meetingFebruary 21, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansMarch 05, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedMarch 19, 2018
CDEC Final Recommendation issued to applicant and drug plansMarch 26, 2018
CDEC Final Recommendation postedMarch 28, 2018
Final CDR review report(s) and patient input postedApril 24, 2018

Tags

hepatitis, infectious diseases, hepatitis b, liver cirrhosis, hepatitis; hepatitis b; tenofovir alafenamide