European Medicines Agency (EMA) with the European Commission; national competent authorities in each member state
Is Tirzepatide legal in European Union?
The regulator has approved it as a medicine.
Mounjaro was authorised centrally on 15 September 2022. It is indicated for insufficiently controlled type 2 diabetes in adults, adolescents and children from 10 years, and for weight management in adults with obesity or with overweight plus a weight-related condition. It is prescription-only. Coverage depends on the member state: in Germany it is excluded from statutory health insurance when used for weight reduction (G-BA Annex II), in Italy it is reimbursed for type 2 diabetes but not for obesity, and France began reimbursing it for obesity on 15 June 2026 with strict criteria.
Last verified 2026-09-29 · how we verify
Tirzepatide elsewhere
Sources (4)
- 01Mounjaro: EPAR (European public assessment report)European Medicines Agency · 2026-09-21 · accessed 2026-09-29
- 02New diabetes and obesity medicines: an AIFA guideItalian Medicines Agency (AIFA) · 2026-05-18 · accessed 2026-09-29
- 03Obesite: prise en charge de Wegovy et Mounjaro a partir du 15 juin 2026, sous conditionsVidal · 2026-05-28 · accessed 2026-09-29
- 04Arzneimittel-Richtlinie Anlage II: Lifestyle-Arzneimittel (Stand 20. August 2025)Gemeinsamer Bundesausschuss (G-BA) · 2025-08-20 · accessed 2026-09-29