Approval · Notice of Compliance 18754 · 2016
STELARA: Notice of Compliance 18754
Issued December 12, 2016
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
- 18754
- Date
- December 12, 2016
- Company
- Janssen Inc.Toronto, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: stelara (ustekinumab) is indicated for the treatment of adult patients with moderately to severely active crohn's diseasee who have had an inadequate response, loss of response to or were intolerant to either immunomodulators or one or more tumour necrosisi factor-alpha (tnfa) antagonists, or have had an inadequate response, intolerance or demonstrated dependence on corticosteroids. stelara (ustekinumab) should be used only by physicians who have sufficient knowledge of plaque psoriasis, psoriatic arthritis and'or crohn's diseasee and who have fully familiarized themselves with the efficacy/safety profile of the drug.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| STELARA | 02459671 | Marketed |
| STELARA | Not yet assigned | — |
Medicinal ingredients
- USTEKINUMAB 5 MG per ML
- USTEKINUMAB 45 MG per 0.5ML
- USTEKINUMAB 90 MG per ML