Approval · Notice of Compliance 36009 · 2025
COLUMVI: Notice of Compliance 36009
Issued September 15, 2025
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
- 36009
- Date
- September 15, 2025
- Company
- Hoffmann-La Roche LimitedMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New manufacturing process and technology transfer
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| COLUMVI | Not yet assigned | — |
Medicinal ingredients
- GLOFITAMAB 2.5 MG per VIAL
- GLOFITAMAB 10 MG per VIAL