Approval · Notice of Compliance 34641 · 2024
OTULFI: Notice of Compliance 34641
Issued December 30, 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
- 34641
- Date
- December 30, 2024
- Company
- Fresenius Kabi Canada LtdToronto, Ontario, Canada
- Product type
- Biologic
- Submission
- New Drug Submission (NDS)
- Submission class
- Other
- Canadian reference product
- STELARA; STELARA I.V.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| OTULFI | 02554283 | Marketed |
| OTULFI | 02554291 | Marketed |
| OTULFI I.V. | 02554305 | Marketed |
Medicinal ingredients
- USTEKINUMAB 45 MG per 0.5ML
- USTEKINUMAB 90 MG per ML
- USTEKINUMAB 5 MG per ML