Last Updated : November 23, 2017
Details
FilesGeneric Name:
abobotulinumtoxinA
Project Status:
Complete
Therapeutic Area:
Upper limb spasticity
Manufacturer:
IPSEN Biopharmaceuticals Canada, Inc.
Call for patient/clinician input open:
Brand Name:
Dysport Therapeutic
Project Line:
Reimbursement Review
Project Number:
SR0517-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Submission Type:
Initial
Fee Schedule:
Schedule B
Indications:
Upper limb spasticity
Date NOC Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
Key Milestones2 |
|
|---|---|
| Call for patient input posted3 | March 17, 2017 |
| Patient group input closed3 | May 08, 2017 |
| Clarification:
-Patient input submission received |
|
| Patient input summary sent for review to patient input groups | May 15, 2017 |
| Patient group comments on input summary closed | May 23, 2017 |
| Clarification:
-Patient input summary feedback received |
|
| Submission received | April 24, 2017 |
| Submission accepted for review | May 08, 2017 |
| Review initiated | May 09, 2017 |
| Draft CDR review report(s) sent to applicant | July 31, 2017 |
| Comments from applicant on draft CDR review report(s) received | August 10, 2017 |
| Redaction requests from applicant on draft CDR review report(s) received | August 17, 2017 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | September 08, 2017 |
| Canadian Drug Expert Committee (CDEC) meeting | September 20, 2017 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | October 02, 2017 |
| Embargo4 period ended and validation of redacted CDR review report(s) received | October 17, 2017 |
| CDEC Final Recommendation issued to applicant and drug plans | October 24, 2017 |
| CDEC Final Recommendation posted5 | October 26, 2017 |
| Final CDR review report(s) and patient input posted5 | November 16, 2017 |
Files
Last Updated : November 23, 2017