Approval · Notice of Compliance 36361 · 2025
ZORYVE: Notice of Compliance 36361
Issued November 12, 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
- 36361
- Date
- November 12, 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: ZORYVE (roflumilast foam, 0.3%) is indicated for topical treatment of plaque psoriasis of the scalp and body in patients 12 years of age and older
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ZORYVE | Not yet assigned | — |
Medicinal ingredients
- ROFLUMILAST 0.3 PER