Approval · Notice of Compliance 36822 · 2026
OTULFI: Notice of Compliance 36822
Issued February 2, 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
- 36822
- Date
- February 2, 2026
- Company
- Fresenius Kabi Canada LtdToronto, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New presentation. Indication expansion: OTULFI (ustekinumab) is indicated for the treatment of chronic moderate to severe plaque psoriasis in pediatric patients (6-17 years of age) who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
- Canadian reference product
- STELARA
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| OTULFI | Not yet assigned | — |
| OTULFI | 02565420 | Approved |
| OTULFI I.V. | Not yet assigned | — |
Medicinal ingredients
- USTEKINUMAB 45 MG per 0.5ML
- USTEKINUMAB 90 MG per ML
- USTEKINUMAB 5 MG per ML