Byetta
exenatide
Table of contents
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.
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List item
Byetta : EPAR - Summary for the public (PDF/62.36 KB)
First published: 18/02/2009
Last updated: 08/06/2012 -
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List item
Byetta : EPAR - Risk-management-plan summary (PDF/365.15 KB) (new)
First published: 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
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.