CRESTOR Film Coated Tablet 20 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
28-03-2023
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Active ingredient:
ROSUVASTATIN
Available from:
G & A Licensing Limited
Dosage:
20 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2012-01-27
Summary of Product characteristics
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Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Crestor 20mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg rosuvastatin (as rosuvastatin calcium).
Contains lactose monohydrate.
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets
Product imported from Romania
Round, biconvex, pink coloured tablets, engraved with ‘ZD4522’ and ‘20’ on one side and plain on the reverse.
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
Treatment of hypercholesterolaemia
Adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia (type IIa including
heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to
diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate.
Homozygous familial hypercholesterolaemia as an adjunct to diet and other lipid lowering treatments (e.g. LDL
apheresis) or if such treatments are not appropriate.
Prevention of Cardiovascular Events
Prevention of major cardiovascular events in patients who are estimated to have a high risk for a first cardiovascular
event (see Section 5.1), as an adjunct to correction of other r
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