Bydureon

Withdrawn

This medicine's authorisation has been withdrawn

exenatide

Overview

On 1 January 2026, the European Commission withdrew the marketing authorisation for Bydureon (exenatide) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, AstraZeneca AB, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Bydureon was granted marketing authorisation in the EU on 17 June 2011 for treatment of type 2 diabetes mellitus treatment of type 2 diabetes mellitus. It was then granted unlimited validity in 2016.

Bydureon : EPAR - Summary for the public

Bydureon : EPAR - Risk management plan summary

Product information

Bydureon : EPAR - Product Information

Bydureon : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Bydureon
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/002020
• Marketing authorisation holder:
  AstraZeneca AB

  151 85 Södertälje; Sweden

• Opinion adopted:
  14/04/2011
• Marketing authorisation issued:
  17/06/2011
• Withdrawal of marketing authorisation:
  01/01/2026
• Revision:
  27

Assessment history

Changes since initial authorisation of medicine

Bydureon : EPAR - Procedural steps taken and scientific information after authorisation

CHMP post-authorisation summary of opinion for Bydureon (II-73)

Adopted Reference Number: EMA/CHMP/224384/2022

Bydureon-H-C-2020-P46-028 : EPAR - Assessment report

Adopted Reference Number: EMA/94820/2021

Bydureon-H-C-PSUSA-00009147-202003 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/120245/2021

Bydureon-H-C-2020-X-0048-G : EPAR - Assessment Report - Extension

Adopted Reference Number: EMA/700805/2018

Bydureon-H-C-002020-II-0045 : EPAR - Assessment report - Variation

Adopted Reference Number: EMA/717429/2017

Bydureon-H-C-2020-II-0041 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/538242/2017

CHMP post-authorisation summary of positive opinion for Bydureon (II-45)

Adopted Reference Number: EMA/659394/2017

CHMP post-authorisation summary of positive opinion for Bydureon (II-41)

Adopted Reference Number: EMA/CHMP/405393/2017

Bydureon-H-C-PSUSA-00009147-201503 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/772289/2015

Bydureon-H-C-2020-PSUV-0024 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/52426/2015

Bydureon-H-C-2020-PSUV-0018 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/394090/2014

Bydureon-H-C-2020-PSUV-0014 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/CHMP/630136/2013

Bydureon-H-C-2020-PSU-0014 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/CHMP/780867/2013

Bydureon-H-C-002020-II-0073 : EPAR - Assessment report - Variation

Adopted Reference Number: EMA/CHMP/644257/2022

Initial marketing authorisation documents

CHMP summary of positive opinion for Bydureon

Adopted Reference Number: EMA/CHMP/103509/2011