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NOVAPHEN (Nova Pharmaceuticals Australasia Pty Ltd)
Product name
NOVAPHEN
Date registered
Evaluation commenced
Decision date
Approval time
123 (255 working days)
Active ingredients
phentermine hydrochloride
Registration type
New generic medicine
Indication
NOVAPHEN is an anorectic agent indicated in the management of obesity as a shortterm adjunct in a medically monitored comprehensive regimen of weight reduction based, for example, on exercise, diet (caloric/kilojoule restriction) and behaviour modification in obese patients with a body mass index (BMI) of 30 kg/m2 or greater. The treatment with NOVAPHEN can be initiated in overweight patients with a lower BMI (25 to 29.9 kg/m2), which increases the risk of morbidity from a number of disorders. Secondary organic causes of obesity should be excluded by diagnosis before prescribing this agent.