- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Eperzan has been withdrawn at the request of the marketing-authorisation holder.
Product information
This medicine’s product information is available in all official EU languages.
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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).