Lyxumia
lixisenatide
Table of contents
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.
-
List item
Lyxumia : EPAR - Summary for the public (PDF/77.46 KB)
First published: 14/03/2013
Last updated: 15/10/2014 -
-
List item
Lyxumia : EPAR - Risk-management-plan summary (PDF/90.67 KB)
First published: 18/01/2021
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 Winthrop Industrie
|
Revision |
19
|
Date of issue of marketing authorisation valid throughout the European Union |
31/01/2013
|
Contact address |
82 Avenue Raspail |
Product information
17/07/2023 Lyxumia - EMEA/H/C/002445 - N/0043
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.