Last Updated : April 30, 2018
Details
FilesGeneric Name:
tenofovir alafenamide
Project Status:
Complete
Therapeutic Area:
Hepatitis B, chronic
Manufacturer:
Gilead Sciences Canada, Inc.
Call for patient/clinician input open:
Brand Name:
Vemlidy
Project Line:
Reimbursement Review
Project Number:
SR0537-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Hepatitis B, chronic
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
Key Milestones2 |
|
|---|---|
| Call for patient input posted | August 30, 2017 |
| Patient group input closed | October 20, 2017 |
| Clarification:
- Patient input submission received |
|
| Patient input summary sent for review to patient input groups | November 02, 2017 |
| Patient group comments on input summary closed | November 09, 2017 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | September 28, 2017 |
| Submission accepted for review | October 13, 2017 |
| Review initiated | October 16, 2017 |
| Draft CDR review report(s) sent to applicant | January 04, 2018 |
| Comments from applicant on draft CDR review report(s) received | January 15, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | January 22, 2018 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | February 08, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | February 21, 2018 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | March 05, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | March 19, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | March 26, 2018 |
| CDEC Final Recommendation posted | March 28, 2018 |
| Final CDR review report(s) and patient input posted | April 24, 2018 |
Files
Last Updated : April 30, 2018