Last Updated : April 18, 2019
Details
FilesGeneric Name:
fluticasone propionate / salmeterol xinafoate
Project Status:
Complete
Therapeutic Area:
Asthma
Manufacturer:
TEVA Canada Innovation
Brand Name:
Arbesda RespiClick
Project Line:
Reimbursement Review
Project Number:
SR0540-000
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Submission Type:
Initial
Fee Schedule:
Schedule C
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 | April 18, 2018 |
| Patient group comments on input summary closed | April 25, 2018 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | October 04, 2017 |
| Submission accepted for review | February 20, 2018 |
| Clarification:
- Submission was not accepted for review on 19 Oct 2017 - Revised category 1 requirements received on 14 Feb 2018 |
|
| Review initiated | February 28, 2018 |
| Draft CADTH review report(s) sent to applicant | May 23, 2018 |
| Comments from applicant on draft CADTH review report(s) received | June 08, 2018 |
| Redaction requests from applicant on draft CADTH review report(s) received | June 15, 2018 |
| CADTH review team's comments on draft CADTH review report(s) sent to applicant | July 06, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | July 18, 2018 |
| CDEC recommendation & redacted CADTH review report(s) sent to applicant and drug plans | July 31, 2018 |
| Embargo period ended and validation of redacted CADTH 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 CADTH review report(s) and patient input posted | January 17, 2019 |
Files
Last Updated : April 18, 2019