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Darunavir/cobicistat/emtricitabine/tenofovir alafenamide

Last Updated: August 8, 2018
Result type: Reports
Project Number: SR0552-000
Product Line: Common Drug Review

Generic Name: Darunavir/cobicistat/emtricitabine/tenofovir alafenamide

Brand Name: Symtuza

Manufacturer: Janssen Inc.

Indications: HIV-1 infection

Submission Type: New

Project Status: Complete

Biosimilar: No

Date Recommendation Issued: July 25, 2018

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule: Schedule C

Key Milestones2

Call for patient input postedNovember 24, 2017
Patient group input closedJanuary 22, 2018
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsFebruary 01, 2018
Patient group comments on input summary closedFebruary 08, 2018
Clarification:

- No patient input summary feedback received

Submission receivedDecember 22, 2017
Submission accepted for reviewJanuary 15, 2018
Review initiatedJanuary 16, 2018
Draft CDR review report(s) sent to applicantApril 02, 2018
Comments from applicant on draft CDR review report(s) receivedApril 11, 2018
Redaction requests from applicant on draft CDR review report(s) receivedApril 18, 2018
CDR review team's comments on draft CDR review report(s) sent to applicantJune 08, 2018
Canadian Drug Expert Committee (CDEC) meetingJune 20, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansJuly 04, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedJuly 18, 2018
CDEC Final Recommendation issued to applicant and drug plansJuly 25, 2018
CDEC Final Recommendation postedJuly 27, 2018
Final CDR review report(s) and patient input postedAugust 07, 2018

Tags

infectious diseases, anti-retroviral agents, hiv, hiv/aids, Symtuza; darunavir; cobicistat; emtricitabine; tenofovir alafenamide; HIV; Antiretroviral