Last Updated : August 8, 2018
Details
FilesGeneric Name:
Darunavir/cobicistat/emtricitabine/tenofovir alafenamide
Project Status:
Complete
Therapeutic Area:
HIV-1 infection
Manufacturer:
Janssen Inc.
Brand Name:
Symtuza
Project Line:
Reimbursement Review
Project Number:
SR0552-000
Performance Metric:
Achieved
Biosimilar:
No
Submission Type:
Initial
Fee Schedule:
Schedule C
Indications:
HIV-1 infection
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
Key Milestones2 | |
|---|---|
| Call for patient input posted | November 24, 2017 |
| Patient group input closed | January 22, 2018 |
| Clarification: - Patient input submission received | |
| Patient input summary sent for review to patient input groups | February 01, 2018 |
| Patient group comments on input summary closed | February 08, 2018 |
| Clarification: - No patient input summary feedback received | |
| Submission received | December 22, 2017 |
| Submission accepted for review | January 15, 2018 |
| Review initiated | January 16, 2018 |
| Draft CDR review report(s) sent to applicant | April 02, 2018 |
| Comments from applicant on draft CDR review report(s) received | April 11, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | April 18, 2018 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | June 08, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | June 20, 2018 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | July 04, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | July 18, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | July 25, 2018 |
| CDEC Final Recommendation posted | July 27, 2018 |
| Final CDR review report(s) and patient input posted | August 07, 2018 |
Files
Last Updated : August 8, 2018