Therapeutic Goods Administration (TGA), Australian Government Department of Health, Disability and Ageing
Is Tirzepatide legal in Australia?
The regulator has approved it as a medicine.
Mounjaro entered the ARTG on 23 December 2022 for adults with type 2 diabetes, and on 10 September 2024 for chronic weight management in adults with obesity, or overweight plus a weight-related condition. PBAC recommended it for type 2 diabetes in March 2026, but the PBS record (as at 1 September 2026) says the company has advised it is not proceeding in the listing process at this time, so it is not subsidised. Two further uses are under TGA evaluation: type 2 diabetes from age 10, and cardiovascular risk reduction. 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.
Last verified 2026-09-29 · how we verify
Tirzepatide elsewhere
Sources (7)
- 01MOUNJARO tirzepatide solution for injection pre-filled pen (ARTG 379330)Therapeutic Goods Administration (TGA) · 2022-12 · accessed 2026-09-29
- 02AusPAR: Mounjaro (tirzepatide), new chemical entityTherapeutic Goods Administration (TGA) · 2023-11-16 · accessed 2026-09-29
- 03AusPAR: Mounjaro (tirzepatide), extension of indications (chronic weight management)Therapeutic Goods Administration (TGA) · 2024-09-26 · accessed 2026-09-29
- 04PBS Medicines Status: tirzepatide (Mounjaro), type 2 diabetes mellitusAustralian Government Department of Health, Disability and Ageing (PBS) · 2026-06-30 · accessed 2026-09-29
- 05Prescription medicines under evaluation: Mounjaro (tirzepatide), proposed use from age 10 (accepted September 2025)Therapeutic Goods Administration (TGA) · 2025-09 · accessed 2026-09-29
- 06Prescription medicines under evaluation: Mounjaro (tirzepatide), cardiovascular risk reduction (accepted December 2025)Therapeutic Goods Administration (TGA) · 2025-12 · accessed 2026-09-29
- 07Manufacturing, supplying and advertising compounded medicines lawfullyTherapeutic Goods Administration (TGA) · 2026-05-14 · accessed 2026-09-29