Canada’s Drug Agency | Drugs, Health Technologies and Systems.
Canada’s Drug Agency | Drugs, Health Technologies and Systems.

ruxolitinib

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Generic Name:
ruxolitinib
Project Status:
Active
Therapeutic Area:
Nonsegmental vitiligo
Manufacturer:
Incyte Biosciences Canada Corporation
Call for patient/clinician input open:
Brand Name:
Opzelura
Project Line:
Reimbursement Review
Project Number:
SR0835-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
​Topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
Key Milestones2
Call for patient/clinician input open05-Sep-24
Call for patient/clinician input closed28-Oct-24
Submission received17-Oct-24
Submission accepted31-Oct-24
Review initiated01-Nov-24
Draft Canada's Drug Agency review report(s) provided to sponsor for comment31-Jan-25
Deadline for sponsors comments11-Feb-25
Canada's Drug Agency review report(s) and responses to comments provided to sponsor13-Mar-25
Expert committee meeting (initial)26-Mar-25
Draft recommendation issued to sponsorApril 07, 2025
To
April 09, 2025
Draft recommendation posted for stakeholder feedback17-Apr-25
End of feedback period05-May-25

Files

Patient and Clinician Group input View PDF
Last Updated : November 22, 2024