Last Updated : March 1, 2018
Details
FilesGeneric Name:
lixisenatide
Project Status:
Complete
Therapeutic Area:
Diabetes mellitus, Type 2
Manufacturer:
Sanofi-aventis Canada Inc.
Call for patient/clinician input open:
Brand Name:
Adlyxine
Project Line:
Reimbursement Review
Project Number:
SR0520-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Diabetes mellitus, Type 2
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
Key Milestones2 |
|
|---|---|
| Call for patient input posted3 | April 26, 2017 |
| Patient group input closed3 | June 15, 2017 |
| Clarification:
- Patient input submission received |
|
| Patient input summary sent for review to patient input groups | June 20, 2017 |
| Patient group comments on input summary closed | June 27, 2017 |
| Clarification:
- No patient input summary feedback received |
|
| Submission received | May 29, 2017 |
| Submission accepted for review | June 12, 2017 |
| Review initiated | June 13, 2017 |
| Draft CDR review report(s) sent to applicant | September 05, 2017 |
| Comments from applicant on draft CDR review report(s) received | September 14, 2017 |
| Redaction requests from applicant on draft CDR review report(s) received | September 21, 2017 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | October 05, 2017 |
| Canadian Drug Expert Committee (CDEC) meeting | October 18, 2017 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | October 31, 2017 |
| Embargo4 period ended and validation of redacted CDR review report(s) received | November 14, 2017 |
| CDEC Final Recommendation issued to applicant and drug plans | November 21, 2017 |
| CDEC Final Recommendation posted5 | November 23, 2017 |
| Final CDR review report(s) and patient input posted5 | December 21, 2017 |
Files
Last Updated : March 1, 2018