PERISYL (Alphapharm Pty Ltd)
Product name
PERISYL
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
150 (255 working days)
Active ingredients
perindopril erbumine
Registration type
New generic medicine
Indication
PERISYL (tablet) is indicated for:
- the treatment of hypertension
- the treatment of heart failure. In such patients it is recommended that perindopril be given with a diuretic and/or digoxin under close medical supervision. (The safety and efficacy of perindopril has not been demonstrated for New York Heart Association Category IV patients) and
- patients with established coronary artery disease (see CLINICAL TRIALS) who are stable on concomitant therapy and have no heart failure, to reduce the risk of non-fatal myocardial infarction or cardiac arrest.