Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1737817
Name of medicinal product: APLERIA
Active substances:
Estonian, English, Latin
ATC code: C03DA04
Dosage form: film-coated tablet
Route of administration: oral use
Strengh: 25mg
Amount in package: 10TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: 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).
Safety features: Yes
Summary of product characteristics (SPC):  (last updated October 23, 2019)
Package information leaflet (PIL): EST  (last updated September 11, 2018)
Labelling:  (last updated September 11, 2018)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: KRKA, d.d., Novo mesto 
Marketing authorization number: 969018 
Marketing authorization issued on: September 11, 2018 
Marketing authorization expires on: September 11, 2024 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Description Additional condition
Perearsti õel on õigus välja kirjutada Välja arvatud esmane retsept
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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