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EMA Product

Bydureon

Product approved by European Medicines Agency (EU)

Basic Information

Bydureon

Regulatory Information

EMEA/H/C/002020

Authorised

June 17, 2011

April 14, 2011

27

November 21, 2024

Company Information

Sweden

151 85 Södertälje

ASTRAZENECA AB

Active Substances Detail

Detailed Information

Therapeutic Indication

### 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.

Overview Summary

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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