Approval · Notice of Compliance 13055 · 2012
SIMVASTATIN: Notice of Compliance 13055
Issued February 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
- 13055
- Date
- February 22, 2012
- Company
- Bentec Pharma IncSaskatoon, Saskatchewan, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- New manufacturer and product name
- Therapeutic class
- Lipid Metabolism Regulator
- Canadian reference product
- ZOCOR (Merck Frosst Canada Inc.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SIMVASTATIN | 02379503 | Cancelled Pre Market |
| SIMVASTATIN | 02379511 | Cancelled Post Market |
| SIMVASTATIN | 02379538 | Cancelled Pre Market |
| SIMVASTATIN | 02379546 | Cancelled Pre Market |
| SIMVASTATIN | 02379554 | Cancelled Pre Market |
Medicinal ingredients
- SIMVASTATIN 5 MG per TAB
- SIMVASTATIN 10 MG per TAB
- SIMVASTATIN 20 MG per TAB
- SIMVASTATIN 40 MG per TAB
- SIMVASTATIN 80 MG per TAB