Is Semaglutide legal in European Union?

Semaglutide holds central EU marketing authorisations: Ozempic (2018) and Rybelsus (2020) for type 2 diabetes, Wegovy (2022) for weight management, and Kayshild (authorised 26 March 2026) for adults with MASH liver disease. Wegovy covers adults and adolescents from 12 years, and its authorisation was extended in 2026 to add an oral tablet for adults after a CHMP opinion in May 2026. Semaglutide is also part of Kyinsu (with insulin icodec, authorised 24 November 2025) for adults with type 2 diabetes. All are prescription-only. No generic semaglutide is authorised centrally; EMA's September 2026 list of applications under evaluation shows three semaglutide applications marked generic or hybrid. Reimbursement for obesity varies by country (for example, statutory health insurance in Germany excludes Wegovy for weight reduction (G-BA Annex II), while France has reimbursed Wegovy since 15 June 2026 under conditions).