Approval · Notice of Compliance 38428 · 2026
SPC-ROSUVASTATIN: Notice of Compliance 38428
Issued October 8, 2026
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
- 38428
- Date
- October 8, 2026
- Company
- Sun Pharma Canada Inc.Brampton, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Other
- Reason
- Administrative: Change in product name / Update to Product Monograph (to align with CRP approved PM) / Update to package labels
- Canadian reference product
- CRESTOR (Astrazeneca Canada Inc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SPC-ROSUVASTATIN | 02382644 | Marketed |
| SPC-ROSUVASTATIN | 02382652 | Marketed |
| SPC-ROSUVASTATIN | 02382660 | Marketed |
| SPC-ROSUVASTATIN | 02382679 | Marketed |
Medicinal ingredients
- ROSUVASTATIN CALCIUM 5 MG per TAB
- ROSUVASTATIN CALCIUM 10 MG per TAB
- ROSUVASTATIN CALCIUM 20 MG per TAB
- ROSUVASTATIN CALCIUM 40 MG per TAB