Generic Name: fluticasone propionate / salmeterol xinafoate
Brand Name: Arbesda RespiClick
Manufacturer: TEVA Canada Innovation
Therapeutic Area: Asthma
Indications: Asthma
Submission Type: Initial
Project Status: Complete
Biosimilar: No
Date Recommendation Issued: December 19, 2018
Recommendation Type: Reimburse with clinical criteria and/or conditions
Fee Schedule: Schedule C
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 |