Lyxumia
Withdrawn
This medicine's authorisation has been withdrawn
lixisenatide
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 18 December 2025, the European Commission withdrew the marketing authorisation for Lyxumia (lixisenatide) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Sanofi Winthrop Industrie, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Lyxumia was granted marketing authorisation in the EU on 1 February 2013 for treatment of type 2 diabetes. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity on 18 September 2017.
Lyxumia is GLP-1 receptor agonist. There are therapeutic alternatives such as other GLP-1 receptor agonists authorised and available throughout the EU for the treatment of type 2 diabetes.
Product information
Latest procedure affecting product information:N/0000223999
27/08/2024
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).
Product details
- Name of medicine
- Lyxumia
- 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
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.
News on Lyxumia
Tópicos
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