Approval · Notice of Compliance 35408 · 2025
PYZCHIVA: Notice of Compliance 35408
Issued May 21, 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
- 35408
- Date
- May 21, 2025
- Company
- Samsung Bioepis Co., LtdIncheon, Incheon, Korea, Republic Of
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Updates to the Product Monograph
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PYZCHIVA | Not yet assigned | — |
| PYZCHIVA IV | Not yet assigned | — |
Medicinal ingredients
- USTEKINUMAB 45 MG per 0.5ML
- USTEKINUMAB 90 MG per ML
- USTEKINUMAB 5 MG per ML