Approval · Notice of Compliance 34217 · 2024
ZORYVE: Notice of Compliance 34217
Issued October 17, 2024
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
- 34217
- Date
- October 17, 2024
- 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 seborrheic dermatitis in patients 9 years of age and older. Pediatrics (9 to <18 years): The safety and efficacy data submitted in patients 9 to 17 are limited. Health Canada has authorized an indication for ZORYVE foam 0.3% for pediatric use primarily from extrapolation of data generated from adult patients. Pediatrics (<9 years): No data for ZORYVE foam 0.3% are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric patients below the age of 9 years.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ZORYVE | 02552566 | Marketed |
Medicinal ingredients
- ROFLUMILAST 0.3 PER