Approval · Notice of Compliance 33539 · 2024
REMSIMA: Notice of Compliance 33539
Issued June 28, 2024
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
- 33539
- Date
- June 28, 2024
- Company
- Celltrion Inc.Incheon, --, Korea, Republic Of
- Product type
- Biologic
- Submission
- New Drug Submission (NDS)
- Submission class
- Admin
- Reason
- Administrative / ¿ Change in Product Ownership
- Canadian reference product
- REMSIMA: REMICADE / REMSIMA SC: N\A
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| REMSIMA | 02419483 | Cancelled Post Market |
| REMSIMA SC | 02511576 | Approved |
| REMSIMA SC | 02511584 | Marketed |
Medicinal ingredients
- INFLIXIMAB 120 MG per ML
- INFLIXIMAB 100 MG per VIAL