Approval · Notice of Compliance 11319 · 2010
CRESTOR: Notice of Compliance 11319
Issued April 29, 2010
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
- 11319
- Date
- April 29, 2010
- Company
- Astrazeneca Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: use in pediatric patients 10-17 years old with heterozygous familial hypercholesterolemia
- Therapeutic class
- Lipid metabolism regulator
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| 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