Approval · Notice of Compliance 38242 · 2026
IMULDOSA: Notice of Compliance 38242
Issued September 8, 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
- 38242
- Date
- September 8, 2026
- Company
- Accord Healthcare IncKirkland, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New Indication : Ulcerative Colitis Imuldosa/Imuldosa I.V. (ustekinumab) is indicated for: • the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies
- Canadian reference product
- STELARA & STELARA I.V.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| IMULDOSA | Not yet assigned | — |
| IMULDOSA I.V. | Not yet assigned | — |
Medicinal ingredients
- USTEKINUMAB 45 MG per 0.5ML
- USTEKINUMAB 90 MG per 1ML
- USTEKINUMAB 130 MG per 26ML