Approval · Notice of Compliance 35471 · 2025
STEQEYMA: Notice of Compliance 35471
Issued June 4, 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
- 35471
- Date
- June 4, 2025
- Company
- Celltrion Inc.Incheon, Korea, Republic Of
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New Pediatric Indication: Plaque Psoriasis The treatment of chronic moderate to severe plaque psoriasis i n pediatric patients (6-17 years of age) who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.. Addition of a new presentation. Addition of a new manufacturing site
- Canadian reference product
- STELARA - STELARA I.V.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| STEQEYMA | Not yet assigned | — |
| STEQEYMA | 02558270 | Approved |
| STEQEYMA I.V. | Not yet assigned | — |
Medicinal ingredients
- USTEKINUMAB 90 MG per ML
- USTEKINUMAB 45 MG per 0.5ML
- USTEKINUMAB 45 MG per VIAL
- USTEKINUMAB 5 MG per ML