insulin glargine / lixisenatide

This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for Suliqua. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Suliqua.

For practical information about using Suliqua, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 02/08/2019

Authorisation details

Product details
Agency product number
Active substance
  • insulin glargine
  • lixisenatide
International non-proprietary name (INN) or common name
insulin glargine / lixisenatide
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
sanofi-aventis groupe
Date of issue of marketing authorisation valid throughout the European Union
Contact address

54 rue La Boetie
75008 Paris

Product information

13/09/2018 Suliqua - EMEA/H/C/004243 - IB/0007/G


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Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Suliqua is indicated in combination with metformin for the treatment of adults with type 2 diabetes mellitus to improve glycaemic control when this has not been provided by metformin alone or metformin combined with another oral glucose lowering medicinal product or with basal insulin.

Assessment history

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