This is a summary of the European public assessment report (EPAR) for Bydureon. 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 Bydureon.
Bydureon : EPAR - Summary for the public (PDF/80.28 KB)
First published: 05/07/2011
Last updated: 19/01/2018
|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||
27/11/2018 Bydureon - EMEA/H/C/002020 - IAIN/0055
- 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
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 and sulphonylurea
- Metformin and thiazolidinedione
in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies.
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