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Product class:
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Authorized package
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Medicinal product class:
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For human use
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Package code:
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1470642
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Name of medicinal product:
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ASTATOR
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Active substances:
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ATC code:
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C10AA05
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Dosage form:
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film-coated tablet
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Route of administration:
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oral use
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Strengh:
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60mg
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Amount in package:
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90TK
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Legal status for supply*:
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Subject to medicinal prescription
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Class of active substance:
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Additional information:
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Indication:
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Hypercholesterolaemia
Atorvastatin Miklich is indicated as an adjunct to diet for reduction of elevated total cholesterol (totalC), LDL-cholesterol (LDL-C), apolipoprotein B, and triglycerides in adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (Corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate.
Atorvastatin Miklich is also indicated to reduce total-C and LDL-C in adults 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 in adult patients estimated to have a high risk for a first cardiovascular event (see section 5.1), as an adjunct to correction of other risk factors.
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Safety features:
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Yes
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Summary of product characteristics (SPC):
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 (last updated October 4, 2022)
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Package information leaflet (PIL):
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EST (last updated October 4, 2022)
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Labelling:
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(last updated August 30, 2021)
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Last imported to Estonia:
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Never imported to Estonia
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Marketing authorization holder:
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KRKA d.d. Novo mesto
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Marketing authorization number:
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742511
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Marketing authorization issued on:
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May 3, 2011
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Marketing authorization expires on:
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Unlimited
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Marketing authorization procedure type:
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Decentralised
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Reference price:
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Under reference price:
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Reference price of daily dose:
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Description
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Additional condition
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Perearsti õel on õigus välja kirjutada
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Välja arvatud esmane retsept
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Entry/Changing date:
October 4, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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