Therapeutic Goods Administration (TGA), Australian Government Department of Health, Disability and Ageing
Is Semaglutide legal in Australia?
The regulator has approved it as a medicine.
Semaglutide was first registered in Australia on 28 August 2019 (Ozempic, type 2 diabetes). Rybelsus (tablets) followed on 7 February 2022, and Wegovy for chronic weight management in adults on 1 September 2022, with a use in adolescents aged 12 and over added on 29 February 2024. The PBS lists semaglutide injection for type 2 diabetes. PBAC recommended Wegovy for people with established cardiovascular disease and obesity in November 2025, but as at 1 September 2026 the PBS record shows the listing had not yet occurred. A revised Novo Nordisk proposal for Wegovy in established atherosclerotic cardiovascular disease with obesity is listed for the November 2026 PBAC meeting. Since 1 October 2024 pharmacists must not compound medicines containing GLP-1 receptor agonist analogues, and the usual exemption for individually prescribed compounded medicines does not cover them. A further Ozempic use (leg-artery claudication in type 2 diabetes) is under TGA evaluation.
Last verified 2026-09-29 · how we verify
Semaglutide elsewhere
Sources (9)
- 01OZEMPIC semaglutide solution for injection pre-filled pen (ARTG 308324)Therapeutic Goods Administration (TGA) · 2019-08 · accessed 2026-09-29
- 02WEGOVY semaglutide solution for injection pre-filled pen (ARTG 356286)Therapeutic Goods Administration (TGA) · 2022-09 · accessed 2026-09-29
- 03RYBELSUS semaglutide tablet blister pack (ARTG 346198)Therapeutic Goods Administration (TGA) · 2022-02 · accessed 2026-09-29
- 04AusPAR: Wegovy (semaglutide), extension of indication (weight management in adolescents aged 12 and over; ARTG entry 29 February 2024)Therapeutic Goods Administration (TGA) · 2024-09-05 · accessed 2026-09-29
- 05PBS Medicines Status: semaglutide (Ozempic), type 2 diabetes mellitusAustralian Government Department of Health, Disability and Ageing (PBS) · 2026-03-31 · accessed 2026-09-29
- 06PBS Medicines Status: semaglutide (Wegovy), established cardiovascular disease with obesityAustralian Government Department of Health, Disability and Ageing (PBS) · 2026-07-23 · accessed 2026-09-29
- 07Manufacturing, supplying and advertising compounded medicines lawfullyTherapeutic Goods Administration (TGA) · 2026-05-14 · accessed 2026-09-29
- 08Prescription medicines under evaluation: Ozempic (semaglutide), claudication in peripheral arterial disease (accepted September 2025)Therapeutic Goods Administration (TGA) · 2025-09 · accessed 2026-09-29
- 09PBS Medicines Status: semaglutide (Wegovy), established atherosclerotic cardiovascular disease with obesity (November 2026 PBAC meeting)Australian Government Department of Health, Disability and Ageing (PBS) · 2026-07-23 · accessed 2026-09-29