Approval · Notice of Compliance 38144 · 2026
ZORYVE: Notice of Compliance 38144
Issued August 19, 2026
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
- 38144
- Date
- August 19, 2026
- 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 pediatric indication: ZORYVE® (roflumilast cream, 0.05%) is indicated for topical treatment of mild to moderate atopic dermatitis in pediatric patients 2 to 5 years of age. Addition of new strength: 0.05% w/w cream
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ZORYVE | 02570793 | Marketed |
Medicinal ingredients
- ROFLUMILAST 0.05 PER