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Last Updated: January 7, 2019
Result type: Reports
Project Number: SR0538-000
Product Line: Reimbursement Review

Generic Name: nitisinone

Brand Name: MDK-Nitisinone

Manufacturer: MendeliKABS Inc

Therapeutic Area: Hereditary tyrosinemia type 1

Indications: Hereditary tyrosinemia type 1

Submission Type: Initial

Project Status: Complete

Biosimilar: No

Date Recommendation Issued: April 25, 2018

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule: Schedule A

Key Milestones2

Call for patient input postedAugust 31, 2017
Patient group input closedOctober 23, 2017

- Patient input submission received

Submission receivedSeptember 29, 2017
Submission accepted for reviewOctober 16, 2017
Review initiatedOctober 20, 2017
Draft CDR review report(s) sent to applicantJanuary 24, 2018
Comments from applicant on draft CDR review report(s) receivedFebruary 02, 2018
Redaction requests from applicant on draft CDR review report(s) receivedFebruary 09, 2018
Canadian Drug Expert Committee (CDEC) meetingMarch 21, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansApril 04, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedApril 18, 2018
CDEC Final Recommendation issued to applicant and drug plansApril 25, 2018
CDEC Final Recommendation postedApril 27, 2018
Final CDR review report(s) and patient input postedApril 27, 2018