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.
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List item
Lyxumia : EPAR - Summary for the public (PDF/77.46 KB)
First published: 14/03/2013
Last updated: 15/10/2014 -
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List item
Lyxumia : EPAR - Risk-management-plan summary (PDF/90.67 KB)
First published: 18/01/2021
Authorisation details
Product details | |
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Name |
Lyxumia
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Agency product number |
EMEA/H/C/002445
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Active substance |
lixisenatide
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International non-proprietary name (INN) or common name |
lixisenatide
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Therapeutic area (MeSH) |
Diabetes Mellitus, Type 2
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Anatomical therapeutic chemical (ATC) code |
A10BJ03
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Publication details | |
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Marketing-authorisation holder |
Sanofi-aventis groupe
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Revision |
12
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Date of issue of marketing authorisation valid throughout the European Union |
31/01/2013
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Contact address |
Product information
10/12/2020 Lyxumia - EMEA/H/C/002445 - II/0030
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
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Drugs used in diabetes
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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.