Approval · Notice of Compliance 12876 · 2011
REMICADE: Notice of Compliance 12876
Issued December 16, 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
- 12876
- Date
- December 16, 2011
- Company
- Janssen Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Expanded indication for Crohn's Disease; reduction of signs and syptoms, induction and maintenance of clinical remission and mucosal healing and reduction of corticosteroid use in adult patients with moderately to severely active Crohn's disease who have had an inadequate respone to a corticosteroid and/or aminoslicylate, REMICADE can be used alone or in combination with 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