Agência Nacional de Vigilância Sanitária (Anvisa)

Is Tirzepatide legal in Brazil?

ApprovedApproved as Mounjaro for type 2 diabetes and, since June 2025, chronic weight management

The regulator has approved it as a medicine.

Mounjaro (Eli Lilly) was registered in September 2023, and in June 2025 Anvisa added chronic weight management for adults with obesity or overweight plus related conditions. A multidose presentation was registered on 2026-03-18. Mounjaro is the only tirzepatide medicine in the register, and it is prescription-only with retention under RDC 973/2025. Anvisa did not ban tirzepatide compounding in August 2025, so it is still allowed on an individual prescription, but Anvisa is revising the rules. In June 2026 Resolution 2.238/2026 suspended one compounder's tirzepatide production for selling standardised, non-individualised product. The same resolution banned several unregistered tirzepatide products, including one from the United States.

Last verified 2026-09-29 · how we verify

Tirzepatide elsewhere

Sources (6)

  1. 01Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)Agência Nacional de Vigilância Sanitária (Anvisa) · 2026-09-29 · accessed 2026-09-29
  2. 02Mounjaro (tirzepatida): nova indicaçãoAgência Nacional de Vigilância Sanitária (Anvisa) · 2025-06-09 · accessed 2026-09-29
  3. 03Anvisa estabelece novas regras para prescrição e dispensação de medicamentos agonistas de GLP-1Conselho Federal de Farmácia (CFF) · 2026-01-16 · accessed 2026-09-29
  4. 04Anvisa proíbe versões manipuladas da semaglutida, usada no OzempicAgência Brasil (EBC) · 2025-08-26 · accessed 2026-09-29
  5. 05Anvisa proíbe venda de tirzepatida irregularAgência Nacional de Vigilância Sanitária (Anvisa) · 2026-06-02 · accessed 2026-09-29
  6. 06Anvisa anuncia novas medidas de combate a irregularidades na importação e manipulação de canetas emagrecedorasAgência Nacional de Vigilância Sanitária (Anvisa) · 2026-04-06 · accessed 2026-09-29