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sebelipase alfa

Last Updated: December 15, 2017
Result type: Reports
Project Number: SR0544-000
Product Line: Common Drug Review

Generic Name: sebelipase alfa

Brand Name: Kanuma

Manufacturer: Alexion Pharmaceuticals

Indications: Lysosomal acid lipase deficiency

Submission Type: New

Project Status: Active

Biosimilar: No

Fee Schedule1: Schedule A

Key Milestones2

Call for patient input posted3October 04, 2017
Patient group input closed3November 23, 2017
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsDecember 04, 2017
Patient group comments on input summary closedDecember 11, 2017
Clarification:

- Patient input summary feedback received

Submission receivedNovember 02, 2017
Submission accepted for reviewNovember 16, 2017
Review initiatedNovember 17, 2017
Draft CDR review report(s) sent to applicantFebruary 14, 2018
Comments from applicant on draft CDR review report(s) receivedFebruary 26, 2018
Redaction requests from applicant on draft CDR review report(s) receivedMarch 05, 2018
CDR review team's comments on draft CDR review report(s) sent to applicantMarch 29, 2018
Canadian Drug Expert Committee (CDEC) meetingApril 11, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansApril 23, 2018
To
April 25, 2018

Tags

genetics, pediatrics