🇪🇺 exenatide, long acting release in European Union

EMA authorised exenatide, long acting release on 17 June 2011

Marketing authorisation

EMA — authorised 17 June 2011

  • Application: EMEA/H/C/002020
  • Marketing authorisation holder: AstraZeneca AB
  • Local brand name: Bydureon
  • 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 o
  • Status: approved

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Other Diabetes approved in European Union

Frequently asked questions

Is exenatide, long acting release approved in European Union?

Yes. EMA authorised it on 17 June 2011.

Who is the marketing authorisation holder for exenatide, long acting release in European Union?

AstraZeneca AB holds the EU marketing authorisation.