Byetta

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exenatide

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Byetta. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Byetta.

This EPAR was last updated on 24/05/2023

Authorisation details

Product details
Name
Byetta
Agency product number
EMEA/H/C/000698
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
28
Date of issue of marketing authorisation valid throughout the European Union
20/11/2006
Contact address
151 85 Sodertalje
Sweden

Product information

14/07/2022 Byetta - EMEA/H/C/000698 - IB/0079

Other EU languages available icon 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:

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

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.

Assessment history

Changes since initial authorisation of medicine

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