Approval · Notice of Compliance 9673 · 2008
ORENCIA: Notice of Compliance 9673
Issued July 11, 2008
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
- 9673
- Date
- July 11, 2008
- Company
- Bristol-Myers Squibb CanadaSt-Laurent, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Orencia is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis/juvenile rheumatoid arthritis in pediatric patients 6 years of age and older who have had an inadequate response to one or more dmards, such as methotrexate (mtx). orencia has not been studied in children less than 6 years of age.
- Therapeutic class
- Selective co-stimulation modulator
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ORENCIA | Not yet assigned | — |
Medicinal ingredients
- ABATACEPT 250 MG per VIAL