rosiglitazone / metformin
The marketing authorisation for Avandamet has expired following the marketing-authorisation holder’s decision not to apply for a renewal.
Avandamet : EPAR - Summary for the public (PDF/752.38 KB)
First published: 18/09/2008
Last updated: 08/06/2016
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Diabetes Mellitus, Type 2
|Anatomical therapeutic chemical (ATC) code||
SmithKline Beecham Plc
|Date of issue of marketing authorisation valid throughout the European Union||
03/12/2010 Avandamet - EMEA/H/C/000522 - A20/0063
- 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
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Drugs used in diabetes
AVANDAMET is indicated in the treatment of type 2 diabetes mellitus patients, particularly overweight patients:
- who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.
- in triple oral therapy with sulphonylurea in patients with insufficient glycaemic control despite dual oral therapy with their maximally tolerated dose of metformin and a sulphonylurea (see section 4.4).