Approval · Notice of Compliance 6314 · 2005
CRESTOR: Notice of Compliance 6314
Issued March 4, 2005
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
- 6314
- Date
- March 4, 2005
- Company
- Astrazeneca Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of 5 mg dosage and updated safety information
- Therapeutic class
- Lipid metabolism regulator
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| CRESTOR | 02265540 | Marketed |
| CRESTOR | Not yet assigned | — |
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