Bydureon

  • Email
  • Help

Questions & Answers

On 12 October 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Bydureon. The marketing authorisation holder for this medicinal product is AstraZeneca AB.

The CHMP adopted a change to the existing indication to extend the use of Bydureon in combination with insulin as follows1:

“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, including basal insulin, 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).”

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1 New text in bold

Name Language First published Last updated
CHMP post-authorisation summary of positive opinion for Bydureon (English only) 2017-10-13  

Key facts

Product details for Bydureon
NameBydureon
INN or common name

exenatide

Therapeutic area Diabetes Mellitus, Type 2
Active substance

exenatide

Date opinion adopted12/10/2017
Company name

AstraZeneca AB

StatusPositive
Application typePost authorisation