Last Updated : January 14, 2019
Details
FilesGeneric Name:
nitisinone
Project Status:
Complete
Therapeutic Area:
Hereditary tyrosinemia type 1
Manufacturer:
MendeliKABS Inc
Call for patient/clinician input open:
Brand Name:
MDK-Nitisinone
Project Line:
Reimbursement Review
Project Number:
SR0538-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Hereditary tyrosinemia type 1
Date NOC Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
Key Milestones2 |
|
|---|---|
| Call for patient input posted | August 31, 2017 |
| Patient group input closed | October 23, 2017 |
| Clarification:
- Patient input submission received |
|
| Submission received | September 29, 2017 |
| Submission accepted for review | October 16, 2017 |
| Review initiated | October 20, 2017 |
| Draft CDR review report(s) sent to applicant | January 24, 2018 |
| Comments from applicant on draft CDR review report(s) received | February 02, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | February 09, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | March 21, 2018 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | April 04, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | April 18, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | April 25, 2018 |
| CDEC Final Recommendation posted | April 27, 2018 |
| Final CDR review report(s) and patient input posted | April 27, 2018 |
Files
Last Updated : January 14, 2019