Byetta

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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 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.

This EPAR was last updated on 06/05/2019

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
22
Date of issue of marketing authorisation valid throughout the European Union
20/11/2006
Contact address
151 85 Sodertalje
Sweden

Product information

12/04/2019 Byetta - EMEA/H/C/000698 - IAIN/0067/G

Contents

  • 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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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.

Assessment history

Changes since initial authorisation of medicine

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