Rosuvastatin

Not applicable

Sandoz Rosuvastatin (rosuvastatin calcium) is indicated in adults as an adjunct to diet, at least equivalent to the Adult Treatment Panel III (ATP III TLC diet), for the reduction of elevated total cholesterol (Total-C), LDL-C, ApoB, the Total-C/HDL-C ratio and triglycerides (TG) and for increasing HDL- C; in hyperlipidemic and dyslipidemic conditions, when response to diet and exercise alone has been inadequate including: • Primary hypercholesterolemia (Type IIa including heterozygous familial hypercholesterolemia and severe non-familial hypercholesterolemia) • Combined (mixed) dyslipidemia (Type IIb) • Homozygous familial hypercholesterolemia where Sandoz Rosuvastatin is used either alone or as an adjunct to diet and other lipid lowering treatments such as apheresis.

1 Pediatrics Pediatrics (10 to <18 years): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of Sandoz Rosuvastatin in pediatric patients has been established. Therefore, Health Canada has authorized an indication for pediatric use as an adjunct to diet to reduce elevated total cholesterol (Total-C), LDL-C and ApoB in boys and girls who are at least one year post- menarche with heterozygous familial hypercholesterolemia (see 14 CLINICAL TRIALS), when response to diet alone has been inadequate.

1 INDICATIONS AND USAGE Rosuvastatin tablets is indicated: To reduce the risk major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor.

As an adjunct to diet to:

Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. Reduce LDL-C and slow the progression of atherosclerosis in adults. Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).

As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH).