Last Updated : January 21, 2019
Details
FilesGeneric Name:
fluticasone propionate
Project Status:
Complete
Therapeutic Area:
Asthma
Manufacturer:
TEVA Canada Innovation
Brand Name:
Aermony RespiClick
Project Line:
Reimbursement Review
Project Number:
SR0539-000
NOC Status at Filing:
Post NOC
Performance Metric:
N/A delay outside our control - Application delayed at sponsor’s request
Biosimilar:
No
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Asthma
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
Key Milestones2 |
|
|---|---|
| Call for patient input posted | September 05, 2017 |
| Patient group input closed | October 25, 2017 |
| Clarification:
- Patient input submission received |
|
| Patient input summary sent for review to patient input groups | March 29, 2018 |
| Patient group comments on input summary closed | April 06, 2018 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | October 04, 2017 |
| Submission accepted for review | October 19, 2017 |
| Review initiated | February 20, 2018 |
| Clarification:
- Initiation was delayed at the request of the manufacturer |
|
| Draft CDR review report(s) sent to applicant | May 16, 2018 |
| Comments from applicant on draft CDR review report(s) received | June 08, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | June 15, 2018 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | July 06, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | July 18, 2018 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | July 31, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | September 13, 2018 |
| Clarification:
- Request for extension to embargo period received from the manufacturer - Embargo extension request granted - Reconsideration requested |
|
| Applicant's request for reconsideration placed on CDEC agenda | December 12, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | December 19, 2018 |
| CDEC Final Recommendation posted | December 21, 2018 |
| Final CDR review report(s) and patient input posted | January 21, 2019 |
Files
Last Updated : January 21, 2019