Approval · Notice of Compliance 33775 · 2024
PYZCHIVA: Notice of Compliance 33775
Issued August 7, 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
- 33775
- Date
- August 7, 2024
- Company
- Samsung Bioepis Co., LtdIncheon, Incheon, Korea, Republic Of
- Product type
- Biologic
- Submission
- New Drug Submission (NDS)
- Submission class
- Other
- Canadian reference product
- STELARA / STELARA I.V.
Products in this notice
Medicinal ingredients
- USTEKINUMAB 45 MG per 0.5ML
- USTEKINUMAB 90 MG per ML
- USTEKINUMAB 5 MG per ML
- USTEKINUMAB 130 MG per 26ML