Wegovy Multi FixDose 1 mg, injection solution im Fertigpen

( ARTG ) Weight Management,Adults,Wegovy is indicated as an adjunct to a reduced-energy diet and increased physical activity for chronic weight management (including weight loss and weight maintenance) in adults with an initial Body Mass Index (BMI) of,? equal to or greater than 30 kg/m2 (obesity), or,? equal to or greater than 27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one weight-related comorbidity (see Section 5.1 Pharmacodynamic Properties Clinical trials).,Adolescents,Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adolescents ages 12 years and above with initial:,? obesity* and,? body weight above 60 kg,Treatment with Wegovy should be re-evaluated and discontinued if adolescent patients have not reduced their BMI by at least 5% after 12 weeks on the 2.4 mg or maximum tolerated dose.,*Obesity (BMI equal to or greater than 95th percentile) as defined on sex- and age-specific BMI growth charts (CDC.gov) (see Table 1).,Table 1 BMI cut-off points for obesity (equal to or greater than 95th percentile) by sex and age for paediatric patients aged 12 and older (CDC criteria),Age (years),BMI (kg/m2) at 95th Percentile,Males Females,12 24.2 25.2,12.5 24.7 25.7,13 25.1 26.3,13.5 25.6 26.8,14 26.0 27.2,14.5 26.4 27.7,15 26.8 28.1,15.5 27.2 28.5,16 27.5 28.9,16.5 27.9 29.3,17 28.2 29.6,17.5 28.6 30.0,Reduction in risk of major adverse cardiovascular events,Wegovy is indicated as an adjunct to standard of care therapy to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with established cardiovascular disease, with a Body Mass Index (BMI) equal to or greater than 27 kg/m2, and without established Type 1 or Type 2 diabetes (see Section 5.1 Pharmacodynamic Properties Clinical trials).Metabolic dysfunction-associated steatohepatitis (MASH),Wegovy is indicated for the treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). This indication was approved via the provisional approval pathway based on resolution of steatohepatitis and improvement in liver fibrosis. Continued approval of this indication depends on verification and description of clinical benefit in confirmatory trials.