Begin main content

ocrelizumab

Last Updated: November 24, 2017
Result type: Reports
Project Number: SR0542-000
Product Line: Common Drug Review

Generic Name: ocrelizumab

Brand Name: Ocrevus

Manufacturer: Hoffman-La Roche Limited

Indications: Primary progressive multiple sclerosis

Submission Type: New Indication

Project Status: Active

Biosimilar: No

Fee Schedule1: Schedule B

Key Milestones2

Call for patient input posted3September 27, 2017
Patient group input closed3November 16, 2017
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsNovember 22, 2017
Patient group comments on input summary closedNovember 29, 2017
Clarification:

- Patient input summary feedback received

Submission receivedOctober 26, 2017
Submission accepted for reviewNovember 09, 2017
Review initiatedNovember 10, 2017
Draft CDR review report(s) sent to applicantJanuary 31, 2018
Comments from applicant on draft CDR review report(s) receivedFebruary 09, 2018
Redaction requests from applicant on draft CDR review report(s) receivedFebruary 16, 2018
CDR review team's comments on draft CDR review report(s) sent to applicantMarch 09, 2018
Canadian Drug Expert Committee (CDEC) meetingMarch 21, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansApril 03, 2018
To
April 05, 2018

Tags

multiple sclerosis