TREMFYA DIN 02570890
Health Canada record
| Active ingredient(s) | GUSELKUMAB 45 MG |
|---|---|
| Dosage form | Solution |
| Route | Subcutaneous |
| Schedule | PRESCRIPTION; SCHEDULE D |
| Class | Human |
| ATC | L04AC16 GUSELKUMAB |
| Original market date | |
| Current status date | 14-Aug-2026 |
| Source | Health Canada DPD |
Establishment licence of the holder
Janssen Inc — licence 100239, currently licensed, last inspection rating C (2026-03-09).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing GUSELKUMAB
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02469758 | TREMFYA | JANSSEN INC | Solution | GUSELKUMAB 100 MG | Marketed |
| 02559137 | TREMFYA | JANSSEN INC | Solution | GUSELKUMAB 200 MG | Approved |
| 02559145 | TREMFYA | JANSSEN INC | Solution | GUSELKUMAB 200 MG | Marketed |
| 02566877 | TREMFYA | JANSSEN INC | Solution | GUSELKUMAB 100 MG | Marketed |
| 02559153 | TREMFYA I.V. | JANSSEN INC | Solution | GUSELKUMAB 200 MG | Marketed |
| 02487314 | TREMFYA ONE-PRESS | JANSSEN INC | Solution | GUSELKUMAB 100 MG | Marketed |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 38113 | 2026-08-14 | Supplement to a New Drug Submission (SNDS) | 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. |