rosiglitazone / glimepiride
The marketing authorisation for Avaglim has been withdrawn for safety reasons following a decision by the European Commission.
Avaglim : EPAR - Summary for the public (PDF/511.34 KB)
First published: 16/06/2008
Last updated: 17/01/2011
|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 Ltd
|Date of issue of marketing authorisation valid throughout the European Union||
26/07/2011 Avaglim - EMEA/H/C/000675 - A20/0029
- 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
AVAGLIM is indicated in the treatment of type 2 diabetes mellitus patients who are unable to achieve sufficient glycaemic control on optimal dosage of sulphonylurea monotherapy, and for whom metformin is inappropriate because of contraindication or intolerance.