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.
Byetta : EPAR - Summary for the public (PDF/62.36 KB)
First published: 18/02/2009
Last updated: 08/06/2012
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Diabetes Mellitus, Type 2
|Anatomical therapeutic chemical (ATC) code||
|Date of issue of marketing authorisation valid throughout the European Union||
12/04/2019 Byetta - EMEA/H/C/000698 - IAIN/0067/G
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Drugs used in diabetes
Byetta is indicated for treatment of type-2 diabetes mellitus in combination with:
- 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.