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The marketing authorisation for Avaglim has been withdrawn for safety reasons following a decision by the European Commission.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||
980 Great West Road
26/07/2011 Avaglim - EMEA/H/C/000675 - A20/0029
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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).
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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.