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nitisinone

Last Updated: June 12, 2018
Result type: Reports
Project Number: SR0554-000
Product Line: Common Drug Review

Generic Name: nitisinone

Brand Name: Nitisinone

Manufacturer: Cycle Pharmaceuticals Ltd.

Indications: Hereditary tyrosinemia type 1

Manufacturer Requested Reimbursement Criteria1: Hereditary tyrosinemia type 1

Submission Type: New

Project Status: Active

Biosimilar: No

Fee Schedule: Schedule A

  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient input postedDecember 14, 2017
Patient group input closedFebruary 09, 2018
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsFebruary 27, 2018
Patient group comments on input summary closedMarch 06, 2018
Clarification:

- Patient input summary feedback received

Submission receivedJanuary 25, 2018
Submission accepted for reviewFebruary 08, 2018
Review initiatedFebruary 09, 2018
Clarification:

- Temporary suspension due to non-payment of the application fee

- Temporary suspension of the review has been lifted

Draft CDR review report(s) sent to applicantMay 31, 2018
Comments from applicant on draft CDR review report(s) receivedJune 11, 2018
Redaction requests from applicant on draft CDR review report(s) receivedJune 18, 2018
CDR review team's comments on draft CDR review report(s) sent to applicantJuly 06, 2018
Canadian Drug Expert Committee (CDEC) meetingJuly 18, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansJuly 30, 2018
To
August 01, 2018

Tags

genetics, pediatrics