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Last Updated: April 18, 2018
Result type: Reports
Project Number: SR0531-000
Product Line: Common Drug Review

Generic Name: nitisinone

Brand Name: Orfadin

Manufacturer: Sobi Canada Inc.

Indications: Hereditary tyrosinemia type 1

Submission Type: New

Project Status: Complete

Biosimilar: No

Date Recommendation Issued: February 21, 2018

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule: Schedule A

Key Milestones2

Call for patient input postedJuly 28, 2017
Patient group input closedSeptember 19, 2017

- Patient input submission received

Patient input summary sent for review to patient input groupsOctober 05, 2017
Patient group comments on input summary closedOctober 13, 2017

- Patient input summary feedback received

Submission receivedAugust 29, 2017
Submission accepted for reviewSeptember 13, 2017
Review initiatedSeptember 14, 2017
Draft CDR review report(s) sent to applicantNovember 27, 2017
Comments from applicant on draft CDR review report(s) receivedDecember 06, 2017
Redaction requests from applicant on draft CDR review report(s) receivedDecember 13, 2017
CDR review team's comments on draft CDR review report(s) sent to applicantJanuary 05, 2018
Canadian Drug Expert Committee (CDEC) meetingJanuary 17, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansJanuary 30, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedFebruary 13, 2018
CDEC Final Recommendation issued to applicant and drug plansFebruary 21, 2018
CDEC Final Recommendation postedFebruary 23, 2018
Final CDR review report(s) and patient input postedApril 18, 2018


digestive system, genetics, pediatrics, tyrosinemias, nitisinone; tyrosinemia