Australia registers Wegovy on the ARTG

Australia's Therapeutic Goods Administration (TGA) entered Wegovy (semaglutide) on the Australian Register of Therapeutic Goods (ARTG), the national list of medicines cleared for supply. The regulator later reviewed a separate submission from Novo Nordisk Pharmaceuticals Pty Limited to widen the label to adolescents, and published its full assessment of that decision in September 2024 ^[1].

That second step has firm dates on the public record. The TGA's decision on the adolescent extension of indication was made on 3 January 2024, and the date of entry onto the ARTG was 29 February 2024, under five ARTG numbers ^[1]. The approved wording covers Wegovy "as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adolescents ages 12 years and above" who have obesity and body weight above 60 kg, with obesity defined as a BMI at or above the 95th percentile on sex- and age-specific CDC growth charts ^[1]. The label also says treatment should be re-evaluated and discontinued if an adolescent's BMI has not fallen by at least 5% after 12 weeks on the 2.4 mg or maximum tolerated dose ^[1].

The registered product is the same weekly injection sold in the United States: pre-filled pens in 0.25 mg, 0.5 mg, 1 mg, 1.7 mg and 2.4 mg strengths, packed two or four pens to a box, injected under the skin of the abdomen, thigh or upper arm ^[1]. The Australian dose schedule steps up from 0.25 mg in weeks 1 to 4, to 0.5 mg in weeks 5 to 8, 1 mg in weeks 9 to 12, 1.7 mg in weeks 13 to 16, then a 2.4 mg maintenance dose ^[1]. Australia assigned the product pregnancy category D and flagged it under the Black Triangle Scheme, the country's marker for medicines under additional monitoring ^[1]. The Australian label states semaglutide should not be used in pregnancy, that contraception is recommended during treatment, and that it should be stopped at least two months before a planned pregnancy because of the drug's long half-life ^[1].

The TGA framed the need in population terms. It cited Australian Institute of Health and Welfare figures showing that in 2017–18 about two in three (67%) Australians aged 18 and over were overweight or obese and 31% were obese — roughly 12.5 million adults ^[1]. It also noted an estimate that high BMI accounted for 4.0 million deaths globally in 2015, or 7.1% of deaths from any cause, with more than two-thirds of those deaths due to cardiovascular disease ^[1].

Why it matters for patients

For US readers, the Australian record is a useful reference point for two reasons. First, it shows that a regulator's sign-off is not the same as a medicine being on pharmacy shelves; being listed on a national register means a product may legally be supplied, not that stock exists. The exact date Wegovy first became available to Australian patients, and the reasons for any gap between registration and supply, are not detailed in the TGA's published assessment of the adolescent submission ^[1].

Second, the adolescent criteria are strikingly specific: age 12 and up, BMI at or above the 95th percentile, body weight above 60 kg, and a built-in 5% BMI response check at 12 weeks ^[1]. Stopping rules like that are becoming a standard feature of obesity-drug labels internationally, and they shape how long treatment continues if weight does not move.

The pregnancy language is also worth noting, because it is stricter than a simple warning: Australia's label calls for contraception during treatment and a two-month washout before a planned pregnancy ^[1].

What happens next

The TGA's adolescent decision took effect with the 29 February 2024 ARTG entry, and the agency published its detailed reasoning in the September 2024 assessment report ^[1]. Because Wegovy remains in the Black Triangle Scheme, Australian patients and clinicians are asked to report suspected problems so new safety signals can be picked up ^[1]. Whether Australia will add further indications, such as cardiovascular risk reduction, has not been reported here.