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Last Updated: March 12, 2018
Result type: Reports
Project Number: SR0533-000
Product Line: Common Drug Review

Generic Name: dupilumab

Brand Name: Dupixent

Manufacturer: Sanofi-Genzyme

Indications: atopic dermatitis

Submission Type: New

Project Status: Active

Biosimilar: No

Fee Schedule: Schedule A

Key Milestones2

Call for patient input postedAugust 15, 2017
Patient group input closedOctober 04, 2017

- Patient input submission received

Patient input summary sent for review to patient input groupsNovember 16, 2017
Patient group comments on input summary closedNovember 21, 2017

- Patient input summary feedback received

Submission receivedOctober 27, 2017
Submission accepted for reviewNovember 10, 2017
Review initiatedNovember 13, 2017

- Submission temporarily suspended pending receipt of information

- Additional information has been received and the temporary suspension of the review has been lifted

Draft CDR review report(s) sent to applicantFebruary 20, 2018
Comments from applicant on draft CDR review report(s) receivedMarch 01, 2018
Redaction requests from applicant on draft CDR review report(s) receivedMarch 08, 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
April 25, 2018


dermatology, dermatitis, atopic, dupilumab; dupixent; Dermatitis; eczema