TREMFYA ONE-PRESS DIN 02487314
Status: Marketed
Holder: JANSSEN INC
Available to quote
Health Canada record
| Active ingredient(s) | GUSELKUMAB 100 MG |
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| Dosage form | Solution |
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| Route | Subcutaneous |
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| Schedule | SCHEDULE D; PRESCRIPTION |
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| Class | Human |
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| ATC | L04AC16 GUSELKUMAB |
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| Original market date | 20-May-2019 |
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| Current status date | 20-May-2019 |
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| Source | Health Canada DPD |
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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 |
| 02570890 | TREMFYA | JANSSEN INC | Solution | GUSELKUMAB 45 MG | Approved |
| 02559153 | TREMFYA I.V. | JANSSEN INC | Solution | GUSELKUMAB 200 MG | Marketed |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|
| 22073 | 2019-04-18 | Supplement to a New Drug Submission (SNDS) | NEW PRESENTATION |
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