Approval · Notice of Compliance 28675 · 2022
SIMPONI I.V.: Notice of Compliance 28675
Issued July 29, 2022
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
- 28675
- Date
- July 29, 2022
- Company
- Janssen Inc.Toronto, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: Simponi I.V., alone or in combination with methotrexate (MTX), is indicated for treatment of active polyarticular juvenile idiopathic arthritis in children 2 years of age and older.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SIMPONI I.V. | Not yet assigned | — |
Medicinal ingredients
- GOLIMUMAB 50 MG per 4ML