Approval · Notice of Compliance 7819 · 2006
REMICADE: Notice of Compliance 7819
Issued March 10, 2006
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
- 7819
- Date
- March 10, 2006
- Company
- Centocor Inc.Leiden, --, Netherlands
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- New indication - treatment of patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy
- Therapeutic class
- Biological response modifier
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| REMICADE | Not yet assigned | — |
Medicinal ingredients
- INFLIXIMAB 100 MG per VIAL