European Medicines Agency (EMA) with the European Commission; national competent authorities in each member state
Is Mazdutide legal in European Union?
Not approvedNo EU marketing authorisation and no application under evaluation
Not approved as a medicine here.
Mazdutide does not appear in the Union Register or in EMA's September 2026 list of applications under evaluation, so it has no EU authorisation. Any approval in another region does not carry over to the EU. Under Article 6 of Directive 2001/83/EC, no medicine may be placed on the market without a marketing authorisation.
Last verified 2026-09-29 · how we verify
Mazdutide elsewhere
Sources (3)
- 01Union Register of medicinal products for human useEuropean Commission · 2026-09-29 · accessed 2026-09-29
- 02Applications for new human medicines under evaluation by the CHMP (September 2026)European Medicines Agency · 2026-09-04 · accessed 2026-09-29
- 03Directive 2001/83/EC on the Community code relating to medicinal products for human use (consolidated text, 1 January 2025)European Union (EUR-Lex) · 2025-01-01 · accessed 2026-09-29