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CONTRAVE (iNova Pharmaceuticals (Australia) Pty Ltd)
Product name
CONTRAVE
Date registered
Evaluation commenced
Decision date
Approval time
203 working days (255)
Active ingredients
naltrexone hydrochloride; bupropion hydrochloride
Registration type
EOI
Indication
New combination
CONTRAVE (tablets) is indicated, as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥18 years) with an initial Body Mass Index (BMI) of:
- ≥ 30 kg/m2 (obese), or
- ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of one or more weight-related co-morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension).