Approval · Notice of Compliance 33906 · 2024
SIMVASTATIN: Notice of Compliance 33906
Issued August 30, 2024
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
- 33906
- Date
- August 30, 2024
- Company
- Sivem Pharmaceuticals UlcSaint-Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Other
- Reason
- Update to Product Monograph (to align with CRP approved PM). New package insert. Administrative: Update to labelling (to match Licensor)
- Canadian reference product
- ZOCOR (Merck Frosst Canada Inc.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SIMVASTATIN | Not yet assigned | — |
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