Avaglim

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Withdrawn

This medicine's authorisation has been withdrawn

rosiglitazone / glimepiride
MedicineHumanWithdrawn

Portuguese is available via eTranslation, the European Commission's machine translation service.

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  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

The marketing authorisation for Avaglim has been withdrawn for safety reasons following a decision by the European Commission.

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Product information

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Latest procedure affecting product information:A20/0029
26/07/2011
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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).

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Product details

Name of medicine
Avaglim
Active substance
  • rosiglitazone
  • glimepiride
International non-proprietary name (INN) or common name
  • rosiglitazone
  • glimepiride
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BD04

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

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.

Authorisation details

EMA product number
EMEA/H/C/000675
Marketing authorisation holder
SmithKline Beecham Ltd

980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom

Marketing authorisation issued
27/06/2006
Revision
11

Assessment history

This page was last updated on

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