Bydureon is a diabetes medicine used together with other diabetes medicines including long-acting insulin to treat adults and children aged 10 years and above with type 2 diabetes whose blood glucose (sugar) levels are not adequately controlled with the other medicines.
Bydureon contains the active substance exenatide.
Bydureon : EPAR - Summary for the public (PDF/108.59 KB)
First published: 05/07/2011
Last updated: 01/08/2022
Bydureon : EPAR - Risk management plan summary (PDF/361.29 KB)
First published: 01/08/2022
Last updated: 22/05/2023
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Diabetes Mellitus, Type 2
|Anatomical therapeutic chemical (ATC) code||
|Date of issue of marketing authorisation valid throughout the European Union||
151 85 Södertälje
31/07/2023 Bydureon - EMEA/H/C/002020 - IAIN/0078/G
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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Drugs used in diabetes
Bydureon is indicated in adults 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products when the therapy in use, together with diet and exercise, does not provide adequate glycaemic control (see section 4.4, 4.5 and 5.1 for available data on different combinations).
Bydureon is indicated for treatment of type 2 diabetes mellitus in combination with:
- Metformin and sulphonylurea
- Metformin and thiazolidinedione
in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies.
European Medicines Agency investigates findings on pancreatic risks with GLP-1-based therapies for type-2 diabetes26/03/2013