fluticasone propionate / salmeterol xinafoate


( Last Updated : April 18, 2019)
Generic 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

Details

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

New Combination Product

Patient Group Input Submissions