roflumilast

Details

Generic Name:
roflumilast
Project Status:
Received
Therapeutic Area:
atopic dermatitis
Manufacturer:
Arcutis Canada, Inc.
Call for patient/clinician input open:
Brand Name:
Zoryve
Project Line:
Reimbursement Review
Project Number:
SR0887-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For topical treatment of mild to moderate atopic dermatitis in patients 6 years of age and older, with inadequate response, intolerance, or contraindications to topical corticosteroids
Submission Type:
Initial
Submission Complexity:
Standard Review
Fee Schedule:
Pending
Indications:
​For topical treatment of mild to moderate atopic dermatitis in patients 6 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 openApril 03, 2025
Call for patient/clinician input closedMay 27, 2025
Submission receivedMay 16, 2025
Submission accepted-