Approval · Notice of Compliance 12584 · 2011
REMICADE: Notice of Compliance 12584
Issued August 31, 2011
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
- 12584
- Date
- August 31, 2011
- Company
- Janssen Inc.Toronto, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- Extension of the Ulcerative Colitis Indication to the Pediatric Population: Reproduction of signs and symptoms, induction and maintenance of c linical remission, and induction of mucosal healing in pediatric patients with moderate to severely active ulcerative colitis who have had an inadequate response to conventional therapy (i.e. aminosalicylate and/or corticosteroid and/or an immunosuppressant). The safety and efficacy of Remicade have not been established in patients less than 6 years of age.
- Therapeutic class
- Biological Response Modifier
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| REMICADE | Not yet assigned | — |
Medicinal ingredients
- INFLIXIMAB 100 MG per VIAL