Generic Name: fluticasone propionate
Brand Name: Aermony RespiClick
Manufacturer: TEVA Canada Innovation
Indications: Asthma
Submission Type: New
Project Status: Active
Biosimilar: No
Fee Schedule: Schedule A
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 - Target CDEC reconsideration meeting date to be determined | |
Tags
asthma, dry powder inhalers, respiratory, aermony; fluticasone propionate; dry powder inhaler; asthmatic; asthmatics; respiclick