Approval · Notice of Compliance 8514 · 2007
REMICADE: Notice of Compliance 8514
Issued January 10, 2007
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
- 8514
- Date
- January 10, 2007
- Company
- Centocor Inc.Leiden, --, Netherlands
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Reducing signs and symptoms, inducing and maintaining clinical remission, inducing and maintaining mucosal healing, and reducing or eliminating corticosteroid use in patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy
- Therapeutic class
- Biologic response modifier
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| REMICADE | Not yet assigned | — |
Medicinal ingredients
- INFLIXIMAB 100 MG per VIAL