European Medicines Agency (EMA) with the European Commission; national competent authorities in each member state
Is Cagrilintide (and CagriSema) legal in European Union?
Not approvedNo EU marketing authorisation; no application on EMA's September 2026 evaluation list
Not approved as a medicine here.
Cagrilintide, alone or combined with semaglutide (CagriSema), has no EU authorisation. It does not appear in the Union Register or in EMA's September 2026 list of applications under evaluation, so it is still an investigational medicine in 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
Cagrilintide (and CagriSema) 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