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Product class:
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Medicinal product with marketing authorization
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Medicinal product class:
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Human medicine
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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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Strength:
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30mg
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Legal status for supply*:
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Subject to medicinal prescription
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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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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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Marketing authorization holder:
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KRKA, d.d., Novo mesto
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Marketing authorization number:
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742311
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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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Assessment report:
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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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Package code
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Name of medicinal product
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Dosage form
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Package
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Legal status
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Reimbursements
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Reference price
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Last imported
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PƤritolumaa
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Additional information
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1470035
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ASTATOR
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film-coated tablet
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30mg 4TK
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Prescription
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1470046
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ASTATOR
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film-coated tablet
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30mg 7TK
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Prescription
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1470057
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ASTATOR
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film-coated tablet
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30mg 10TK
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Prescription
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1470068
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ASTATOR
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film-coated tablet
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30mg 14TK
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Prescription
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1470079
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ASTATOR
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film-coated tablet
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30mg 20TK
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Prescription
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1470080
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ASTATOR
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film-coated tablet
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30mg 28TK
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Prescription
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1470091
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ASTATOR
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film-coated tablet
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30mg 30TK
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Prescription
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1470103
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ASTATOR
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film-coated tablet
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30mg 50TK
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Prescription
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1470114
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ASTATOR
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film-coated tablet
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30mg 56TK
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Prescription
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1470125
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ASTATOR
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film-coated tablet
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30mg 60TK
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Prescription
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1470136
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ASTATOR
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film-coated tablet
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30mg 84TK
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Prescription
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1470147
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ASTATOR
|
film-coated tablet
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30mg 90TK
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Prescription
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1470158
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ASTATOR
|
film-coated tablet
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30mg 98TK
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Prescription
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1470169
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ASTATOR
|
film-coated tablet
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30mg 100TK
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Prescription
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Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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