European Medicines Agency (EMA) with the European Commission; national competent authorities in each member state

Is Exenatide legal in European Union?

ApprovedAuthorised EU-wide for type 2 diabetes as Byetta (2006) and Bydureon (2011)

The regulator has approved it as a medicine.

Exenatide is authorised centrally as Byetta (authorised 2006) and Bydureon (authorised 2011), both from AstraZeneca and both for type 2 diabetes in adults alongside other glucose-lowering medicines. Neither has a weight-management indication in the EU. They are prescription-only medicines.

Last verified 2026-09-29 · how we verify

Molecule

Exenatide explained →

Country

All rules in European Union →

Exenatide elsewhere

AustraliaNot approved
BrazilNot approved
CanadaNot approved
ChinaGenerics available
IndiaApproved
JapanUnverified
MexicoUnverified
New ZealandNot approved
United Arab EmiratesUnverified
United KingdomUnverified
United StatesGenerics available

Sources (2)

01Byetta: EPAR (European public assessment report)European Medicines Agency · 2024-11-06 · accessed 2026-09-29
02Bydureon: EPAR (European public assessment report)European Medicines Agency · 2024-11-21 · accessed 2026-09-29