CORALIDE (Pharmacor Pty Ltd)
Product name
CORALIDE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
128 (255 working days)
Active ingredients
Ivabradine hydrochloride
Registration type
New generic medicine
Indication
Treatment of chronic stable angina
Symptomatic treatment of chronic stable angina due to atherosclerotic coronary artery disease in patients with normal sinus rhythm and heart rate at or above 70 bpm, who are unable to tolerate or have a contraindication to the use of beta-blockers, OR in combination with atenolol 50mg once daily when angina is inadequately controlled.
Treatment of chronic heart failure
Treatment of symptomatic chronic heart failure of NYHA Classes II or III and with documented left ventricular ejection fraction (LVEF) ≤ 35% in adult patients in sinus rhythm and with heart rate at or above 77 bpm, in combination with optimal standard chronic heart failure treatment.