fluticasone propionate


( Last Updated : January 21, 2019)
Generic 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

Details

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

Recommendation and Reasons

Clinical Report

Pharmacoeconomic Report

Patient Group Input Submissions