Byetta

Withdrawn

This medicine's authorisation has been withdrawn

exenatide

Overview

On 1 January 2026, the European Commission withdrew the marketing authorisation for Byetta (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. 

Byetta was granted marketing authorisation in the EU on 20 November 2006 for treatment of type 2 diabetes mellitus. It was then granted unlimited validity in 2016.

Byetta : EPAR - Summary for the public

Byetta : EPAR - Risk-management-plan summary

Product information

Byetta : EPAR - Product Information

Byetta : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Byetta
• 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

Byetta is indicated for treatment of type-2 diabetes mellitus in combination with:

• metformin;
• sulphonylureas;
• thiazolidinediones;
• metformin and a sulphonylurea;
• metformin and a thiazolidinedione;

in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies. Byetta is also indicated as adjunctive therapy to basal insulin with or without metformin and / or pioglitazone in adults who have not achieved adequate glycaemic control with these agents.

Authorisation details

• EMA product number:
  EMEA/H/C/000698
• Marketing authorisation holder:
  AstraZeneca AB

  151 85 Sodertalje; Sweden

• Marketing authorisation issued:
  20/11/2006
• Withdrawal of marketing authorisation:
  01/01/2026
• Revision:
  30

Assessment history

Changes since initial authorisation of medicine

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

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

Reference Number: EMA/120245/2021

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

Reference Number: EMA/772251/2015

Byetta-H-C-698-PSUV-0045 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/136381/2015

Byetta-H-C-698-II-0029 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/363251/2012

CHMP post-authorisation summary of positive opinion for Byetta (II-29)

Adopted Reference Number: EMA/CHMP/113061/2012

Byetta-H-C-698-II-0021 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/372238/2010

CHMP post-authorisation summary of positive opinion for Byetta (II-21)

Adopted

Initial marketing authorisation documents

Byetta : EPAR - Procedural steps taken before authorisation

Byetta : EPAR - Scientific Discussion