Approval · Notice of Compliance 35948 · 2025
TREMFYA: Notice of Compliance 35948
Issued September 3, 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
- 35948
- Date
- September 3, 2025
- Company
- Janssen Inc.Toronto, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: TREMFYA /TREMFYA I.V. (guselkumab injection / guselkumab for injection) is indicated for: - the treatment of adult patients with moderately to severely active ulcerative colitis.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TREMFYA | Not yet assigned | — |
| TREMFYA I.V. | Not yet assigned | — |
| TREMFYA ONE-PRESS | Not yet assigned | — |
Medicinal ingredients
- GUSELKUMAB 100 MG per ML
- GUSELKUMAB 200 MG per 20ML