Lyxumia

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lixisenatide

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Lyxumia. 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 Lyxumia.

This EPAR was last updated on 04/10/2017

Authorisation details

Product details
Name
Lyxumia
Agency product number
EMEA/H/C/002445
Active substance
lixisenatide
International non-proprietary name (INN) or common name
lixisenatide
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BJ03
Publication details
Marketing-authorisation holder
Sanofi-aventis groupe
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
31/01/2013
Contact address
54 rue La Boétie
75008 Paris
France

Product information

17/09/2017 Lyxumia - EMEA/H/C/002445 - R/0023

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

  • other blood glucose lowering drugs
  • excl. insulins

Therapeutic indication

Lyxumia is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucose lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4 and 5.1 for available data on the different combinations).

Assessment history

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