Torvalipin Tablet 10 mg

Land: Singapore

Sprog: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv bestanddel:

Atorvastatin calcium 10.36mg corresponding to atorvastatin

Tilgængelig fra:

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

ATC-kode:

C10AA05

Dosering:

10 mg

Lægemiddelform:

TABLET, FILM COATED

Sammensætning:

Atorvastatin calcium 10.36mg corresponding to atorvastatin 10 mg

Indgivelsesvej:

ORAL

Recept type:

Prescription Only

Fremstillet af:

Actavis Ltd

Autorisation status:

ACTIVE

Autorisation dato:

2012-06-22

Produktets egenskaber

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