Approval · Notice of Compliance 34660 · 2025
REMSIMA: Notice of Compliance 34660
Issued January 9, 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
- 34660
- Date
- January 9, 2025
- Company
- Celltrion Inc.Incheon, Korea, Republic Of
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Changes to the drug substance and drug product manufacturing processes.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| REMSIMA | Not yet assigned | — |
Medicinal ingredients
- INFLIXIMAB 100 MG per VIAL