EPLERENONE APOTEX, APO-EPLERENONE (Apotex Pty Ltd)
Product name
EPLERENONE APOTEX, APO-EPLERENONE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
144 working days (255)
Active ingredients
Eplerenone
Registration type
New generic medicine
Indication
EPLERENONE APOTEX, APO-EPLERENONE (tablets) is indicated to reduce the risk of:
- cardiovascular death in combination with standard therapy in patients who have evidence of heart failure and left ventricular impairment within 3-14 days of an acute myocardial infarction
- cardiovascular mortality and morbidity in adult patients with NYHA Class II (chronic) heart failure and left ventricular systolic dysfunction (LVEF ≤ 30% or LVEF ≤ 35% in addition to QRS duration of > 130 msec), in addition to standard optimal therapy.