Bydureon
exenatide
Table of contents
Overview
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.
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List item
Bydureon : EPAR - Summary for the public (PDF/108.59 KB)
First published: 05/07/2011
Last updated: 01/08/2022 -
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List item
Bydureon : EPAR - Risk management plan summary (PDF/361.29 KB) (updated)
First published: 01/08/2022
Last updated: 22/05/2023
Authorisation details
Product details | |
---|---|
Name |
Bydureon
|
Agency product number |
EMEA/H/C/002020
|
Active substance |
exenatide
|
International non-proprietary name (INN) or common name |
exenatide
|
Therapeutic area (MeSH) |
Diabetes Mellitus, Type 2
|
Anatomical therapeutic chemical (ATC) code |
A10BJ01
|
Publication details | |
---|---|
Marketing-authorisation holder |
AstraZeneca AB
|
Revision |
24
|
Date of issue of marketing authorisation valid throughout the European Union |
17/06/2011
|
Contact address |
151 85 Södertälje
Sweden |
Product information
14/07/2022 Bydureon - EMEA/H/C/002020 - IB/0077
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Drugs used in diabetes
Therapeutic indication
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
- Sulphonylurea
- Thiazolidinedione
- Metformin and sulphonylurea
- Metformin and thiazolidinedione
in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies.