Generic Name: Dolutegravir rilpivirine
Brand Name: Juluca
Manufacturer: ViiV Healthcare ULC
Therapeutic Area: HIV infection
Indications: HIV infection
Submission Type: Initial
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 posted | November 23, 2017 |
| Patient group input closed | January 19, 2018 |
| Clarification: - Patient input submission received | |
| Patient input summary sent for review to patient input groups | January 30, 2018 |
| Patient group comments on input summary closed | February 06, 2018 |
| Clarification: - Patient input summary feedback received | |
| Submission received | December 21, 2017 |
| Submission accepted for review | January 12, 2018 |
| Review initiated | January 15, 2018 |
| Draft CDR review report(s) sent to applicant | March 29, 2018 |
| Comments from applicant on draft CDR review report(s) received | April 10, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | April 17, 2018 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | May 04, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | May 16, 2018 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | May 30, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | June 13, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | June 20, 2018 |
| CDEC Final Recommendation posted | June 22, 2018 |
| Final CDR review report(s) and patient input posted | June 22, 2018 |