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NOVERA (Nova Pharmaceuticals Australasia Pty Ltd)

Product name
NOVERA
Sponsor
Nova Pharmaceuticals Australasia Pty Ltd
Date registered
Evaluation commenced
Decision date
Approval time
118 (255 working days)
Active ingredients
Eplerenone
Registration type
New generic medicine
Indication

Tradename 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 (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION and Section 5.1 PHARMACODYNAMIC PROPERTIES - Clinical trials).
  • to reduce the risk of 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 (see Section 5.1 PHARMACODYNAMIC PROPERTIES - Clinical trials).