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ARX-LIRAGLUTIDE (Cipla Australia Pty Ltd)

Product name
ARX-LIRAGLUTIDE
Date registered
Evaluation commenced
Decision date
Approval time
198 (255 working days)
Active ingredients
Liraglutide
Registration type
NCE/ NBE
Indication

ARX-LIRGLUTIDE / CIPLA LIRAGLUTIDE / LIRAGLUTIDE SANDOZ is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients 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 at least one weight related comorbidity, such as dysglycaemia (pre-diabetes and type 2 diabetes mellitus), hypertension, dyslipidaemia, or obstructive sleep apnoea.

Treatment with ARX-LIRGLUTIDE / CIPLA LIRAGLUTIDE / LIRAGLUTIDE SANDOZ should be discontinued after 12 weeks on the 3.0 mg/day dose if a patient has not lost at least 5% of their initial body weight.