Bydureon

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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 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.

This EPAR was last updated on 17/05/2019

Authorisation details

Product details
Name
Bydureon
Agency product number
EMEA/H/C/002020
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
17
Date of issue of marketing authorisation valid throughout the European Union
17/06/2011
Contact address
151 85 Södertälje
Sweden

Product information

08/04/2019 Bydureon - EMEA/H/C/002020 - IAIN/0061

Contents

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Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

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
  • Sulphonylurea
  • Thiazolidinedione
  • Metformin and sulphonylurea
  • Metformin and thiazolidinedione

in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies.

Assessment history

Changes since initial authorisation of medicine

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