Approval · Notice of Compliance 38113 · 2026
TREMFYA: Notice of Compliance 38113
Issued August 14, 2026
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
- 38113
- Date
- August 14, 2026
- Company
- Janssen Inc.Toronto, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New Indications: Plaque Psoriasis • (6 years to 17 years): TREMFYA (guselkumab injection) is indicated for the treatment of pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. • (< 6 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric patients less than 6 years of age. Psoriatic Arthritis • (6 years to 17 years): TREMFYA (guselkumab injection) is indicated in pediatric patients 6 years of age and older with active psoriatic arthritis supported by model-based extrapolation. • (< 6 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric patients less than 6 years of age.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TREMFYA | Not yet assigned | — |
| TREMFYA | 02570890 | Approved |
| TREMFYA ONE-PRESS | Not yet assigned | — |
Medicinal ingredients
- GUSELKUMAB 100 MG per ML
- GUSELKUMAB 45 MG per 0.45ML
- GUSELKUMAB 200 MG per 2ML