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 30/09/2022

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
16
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

22/09/2022 Lyxumia - EMEA/H/C/002445 - IAIN/0036

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

  • Drugs used in diabetes

  • Glucagon-like peptide-1 (GLP-1) analogues

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.

Assessment history

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