- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 29 October 2018, the European Commission withdrew the marketing authorisation for Eperzan (albiglutide) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, GlaxoSmithKline Trading Services Limited, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Eperzan was granted marketing authorisation in the EU on 21 March 2014 for the treatment of type 2 diabetes mellitus.
The European Public Assessment Report (EPAR) for Eperzan is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Product information
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
- Eperzan
- Active substance
- Albiglutide
- International non-proprietary name (INN) or common name
- albiglutide
- Therapeutic area (MeSH)
- Diabetes Mellitus, Type 2
- Anatomical therapeutic chemical (ATC) code
- A10BJ04
Pharmacotherapeutic group
Drugs used in diabetesTherapeutic indication
Eperzan is indicated for the treatment of type 2 diabetes mellitus in adults to improve glycaemic control as:
Monotherapy
When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to contraindications or intolerance.
Add-on combination therapy
In combination with other glucose-lowering medicinal products including basal insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see section 4.4 and 5.1 for available data on different combinations).