Approval · Notice of Compliance 35006 · 2025
ZORYVE: Notice of Compliance 35006
Issued March 13, 2025
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 35006
- Date
- March 13, 2025
- Company
- Arcutis Canada, Inc.North York, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of new indication: for topical treatment of mild to moderate atopic dermatitis in patients 6 years of age and older. Addition of new strength: 0.15% w/w cream
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ZORYVE | 02556146 | Marketed |
Medicinal ingredients
- ROFLUMILAST 0.15 PER