Land: Singapore
Språk: engelsk
Kilde: HSA (Health Sciences Authority)
ATORVASTATIN CALCIUM 20.72 mg EQV ATORVASTATIN
TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
C10AA05
20 mg
TABLET, FILM COATED
ATORVASTATIN CALCIUM 20.72 mg EQV ATORVASTATIN 20 mg
ORAL
Prescription Only
Actavis Ltd
ACTIVE
2012-06-22
1. NAME OF THE MEDICINAL PRODUCT Torvalipin tablets 10 mg Torvalipin tablets 20 mg Torvalipin tablets 40 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10mg of Torvalipin film-coated tablet contains atorvastatin calcium corresponding to 10mg of atorvastatin base. Each 20mg of Torvalipin film-coated tablet contains atorvastatin calcium corresponding to 20mg of atorvastatin base. Each 40mg of Torvalipin film-coated tablet contains atorvastatin calcium corresponding to 40mg of atorvastatin base. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. 10 mg: White, oval, biconvex film-coated tablets marked with “10” on one side and “A” on the other”. 20 mg: White, oval, biconvex film-coated tablets marked with “20” on one side and “A” on the other”. 40 mg: White, oval, biconvex film-coated tablets marked with “40” on one side and “A” on the other”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Hypercholesterolaemia _ Torvalipin is indicated as an adjunct to diet for reduction of elevated total cholesterol, LDLcholesterol, apolipoprotein B, or triglycerides in patients with primary hypercholesterolaemia including heterozygous familial hypercholesterolaemia or combined (mixed) hyperlipidaemia (such as Frederickson’s types IIa and IIb), when satisfactory results have not been obtained by a special diet or measures other than medication. Torvalipin is also indicated to reduce totalcholesterol and LDL-cholesterol in patients with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable. _Prevention of Cardiovascular Disease _ Torvalipin is indicated to reduce the risk of myocardial infarction in adult hypertensive patients without clinically evident coronary heart disease, but with at least three additional risk factors for coronary heart disease such as age ≥ 55 years, male sex, smoking, left ventricular hypertrophy, other specified abnormalities on Les hele dokumentet