Approval · Notice of Compliance 16097 · 2014
STELARA: Notice of Compliance 16097
Issued September 17, 2014
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
- 16097
- Date
- September 17, 2014
- Company
- Janssen Inc.Toronto, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Additional drug substance manufacturing sites
- Therapeutic class
- Selective immunomodulating agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| STELARA | Not yet assigned | — |
Medicinal ingredients
- USTEKINUMAB 45 MG per 0.5ML
- USTEKINUMAB 90 MG per 1ML