Approval · Notice of Compliance 9051 · 2007
LESCOL: Notice of Compliance 9051
Issued September 24, 2007
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
- 9051
- Date
- September 24, 2007
- Company
- Novartis Pharmaceuticals Canada Inc.Montreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: lescol/lescol xl are indicated as an adjunct to diet for the reduction of elevated total cholesterol (total-c) ldl-c and apo b levels in children and adolescents aged 10 years and older with heterozygous familial hypercholesterolemia, and other revisions to the product monograph
- Therapeutic class
- Lipid metabolism regulator
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| LESCOL | Not yet assigned | — |
| LESCOL XL | Not yet assigned | — |
Medicinal ingredients
- FLUVASTATIN SODIUM 20 MG per CAP
- FLUVASTATIN SODIUM 40 MG per CAP
- FLUVASTATIN SODIUM 80 MG per TAB