Approval · Notice of Compliance 11991 · 2011
SIMPONI (AUTOINJECTOR): Notice of Compliance 11991
Issued January 6, 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
- 11991
- Date
- January 6, 2011
- Company
- Centocor Ortho Biotech Inc
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update to the Product Monograph
- Therapeutic class
- Tumor necrosis factor alpha inhibitor
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SIMPONI (AUTOINJECTOR) | Not yet assigned | — |
| SIMPONI (PRE-FILLED SYRINGE) | Not yet assigned | — |
Medicinal ingredients
- GOLIMUMAB 50 MG per 0.5ML