ATORVASTATIN ACTAVIS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-03-2023
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Active ingredient:
ATORVASTASTIN MAGNESIUM TRIHYDRATE
Available from:
Actavis Group PTC ehf
Dosage:
10 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2009-09-11
Summary of Product characteristics
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Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Atorvastatin Actavis 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains: 10 mg of atorvastatin as atorvastatin magnesium trihydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, oval, biconvex film-coated tablets marked with “10” on one side and “A” on the other.
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
Hypercholesterolaemia
Atorvastatin Actavis is used as a supplement to a change in diet for reduction of elevated total cholesterol,
LDL-cholesterol, 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 medical treatment.
Atorvastatin Actavis is also indicated to reduce total-cholesterol 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
Prevention of cardiovascular events
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