Approval · Notice of Compliance 13878 · 2012
OPTIMARK: Notice of Compliance 13878
Issued November 22, 2012
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
- 13878
- Date
- November 22, 2012
- Company
- Mallinckrodt Canada UlcPointe Claire, Quebec, Canada
- Product type
- Nonprescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- Admin
- Reason
- Manufacturer name change
- Therapeutic class
- Paramagnetic intravascular contrast agent for magnetic resonance imaging (mri)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| OPTIMARK | 02242986 | Cancelled Post Market |
| OPTIMARK (SINGLE DOSE PRE-FILLED SYRINGE 10 ML) | 02393158 | Cancelled Pre Market |
| OPTIMARK (SINGLE DOSE PRE-FILLED SYRINGE 15 ML) | 02393166 | Cancelled Pre Market |
| OPTIMARK (SINGLE DOSE PRE-FILLED SYRINGE 20 ML) | 02393174 | Cancelled Pre Market |
| OPTIMARK (SINGLE DOSE PRE-FILLED SYRINGE 30 ML) | 02393182 | Cancelled Pre Market |
Medicinal ingredients
- GADOVERSETAMIDE 330.9 MG per ML