Approval · Notice of Compliance 7612 · 2005
REMICADE: Notice of Compliance 7612
Issued November 14, 2005
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
- 7612
- Date
- November 14, 2005
- Company
- Centocor Inc.Leiden, --, Netherlands
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication - treatment of fistulizing crohn's disease, in adult patients, who have not responded despite a full and adequate course of therapy with conventional treatment
- Therapeutic class
- Biological response modifier
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| REMICADE | Not yet assigned | — |
Medicinal ingredients
- INFLIXIMAB 100 MG per VIAL