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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1737895
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Name of medicinal product:
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APLERIA
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Active substances:
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ATC code:
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C03DA04
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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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50mg
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Amount in package:
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20TK
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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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Eplerenone is indicated:
- in addition to standard therapy including beta-blockers, to reduce the risk of cardiovascular (CV) mortality and morbidity in stable patients with left ventricular dysfunction (LVEF ? 40 %) and clinical evidence of heart failure after recent myocardial infarction (MI).
- in addition to standard optimal therapy, to reduce the risk of CV mortality and morbidity in adult patients with New York Heart Association (NYHA) class II (chronic) heart failure and left ventricular systolic dysfunction (LVEF ?30%) (see section 5.1).
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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 23, 2019)
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Package information leaflet (PIL):
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EST (last updated September 11, 2018)
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Labelling:
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(last updated September 11, 2018)
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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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969118
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Marketing authorization issued on:
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September 11, 2018
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Marketing authorization expires on:
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September 11, 2024
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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 27, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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