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Dolutegravir / rilpivirine

Last Updated: June 22, 2018
Result type: Reports
Project Number: SR0551-000
Product Line: Common Drug Review

Generic Name: Dolutegravir rilpivirine

Brand Name: Juluca

Manufacturer: ViiV Healthcare ULC

Indications: HIV infection

Submission Type: New Combination

Project Status: Complete

Biosimilar: No

Companion Diagnostics: No

Date Recommendation Issued: June 20, 2018

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule: Schedule A

Key Milestones2

Call for patient input postedNovember 23, 2017
Patient group input closedJanuary 19, 2018
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsJanuary 30, 2018
Patient group comments on input summary closedFebruary 06, 2018
Clarification:

- Patient input summary feedback received

Submission receivedDecember 21, 2017
Submission accepted for reviewJanuary 12, 2018
Review initiatedJanuary 15, 2018
Draft CDR review report(s) sent to applicantMarch 29, 2018
Comments from applicant on draft CDR review report(s) receivedApril 10, 2018
Redaction requests from applicant on draft CDR review report(s) receivedApril 17, 2018
CDR review team's comments on draft CDR review report(s) sent to applicantMay 04, 2018
Canadian Drug Expert Committee (CDEC) meetingMay 16, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansMay 30, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedJune 13, 2018
CDEC Final Recommendation issued to applicant and drug plansJune 20, 2018
CDEC Final Recommendation postedJune 22, 2018
Final CDR review report(s) and patient input postedJune 22, 2018

Tags

infectious diseases, hiv, human immunodeficiency virus proteins, hiv/aids, HIV; rilpivirine; dolutegravir; Juluca; human immuno-deficiency virus; Human immunodeficiency virus; human immuno-deficiency viruses; human immunodeficiency viruses