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The marketing authorisation for Avaglim has been withdrawn for safety reasons following a decision by the European Commission.

Avaglim : EPAR - Summary for the public

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Nederlands (NL) (574.86 KB - PDF)

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polski (PL) (639.54 KB - PDF)

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português (PT) (574.95 KB - PDF)

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română (RO) (607.15 KB - PDF)

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slovenčina (SK) (635.29 KB - PDF)

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slovenščina (SL) (630.33 KB - PDF)

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Suomi (FI) (576.98 KB - PDF)

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svenska (SV) (575.64 KB - PDF)

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Product information

Avaglim : EPAR - Product Information

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čeština (CS) (1.83 MB - PDF)

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dansk (DA) (1.27 MB - PDF)

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Deutsch (DE) (1.23 MB - PDF)

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eesti keel (ET) (1.12 MB - PDF)

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ελληνικά (EL) (2.57 MB - PDF)

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français (FR) (1.19 MB - PDF)

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italiano (IT) (1.33 MB - PDF)

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latviešu valoda (LV) (2.07 MB - PDF)

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lietuvių kalba (LT) (1.57 MB - PDF)

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magyar (HU) (1.75 MB - PDF)

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Malti (MT) (1.84 MB - PDF)

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Nederlands (NL) (2.12 MB - PDF)

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polski (PL) (2.02 MB - PDF)

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português (PT) (1.39 MB - PDF)

First published: 08/10/2008Last updated: 17/01/2011
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română (RO) (1.51 MB - PDF)

First published: 08/10/2008Last updated: 17/01/2011
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slovenčina (SK) (1.98 MB - PDF)

First published: 08/10/2008Last updated: 17/01/2011
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slovenščina (SL) (1.88 MB - PDF)

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Suomi (FI) (1.15 MB - PDF)

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svenska (SV) (1.28 MB - PDF)

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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).

Avaglim : EPAR - All Authorised presentations

English (EN) (436.09 KB - PDF)

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български (BG) (522.48 KB - PDF)

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español (ES) (436.31 KB - PDF)

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čeština (CS) (475.2 KB - PDF)

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dansk (DA) (436.62 KB - PDF)

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Deutsch (DE) (435.54 KB - PDF)

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eesti keel (ET) (436.51 KB - PDF)

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ελληνικά (EL) (518.76 KB - PDF)

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français (FR) (436.15 KB - PDF)

First published: 12/04/2007Last updated: 17/01/2011
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italiano (IT) (435.76 KB - PDF)

First published: 12/04/2007Last updated: 17/01/2011
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latviešu valoda (LV) (511.76 KB - PDF)

First published: 12/04/2007Last updated: 17/01/2011
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lietuvių kalba (LT) (504.68 KB - PDF)

First published: 12/04/2007Last updated: 17/01/2011
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magyar (HU) (550.99 KB - PDF)

First published: 12/04/2007Last updated: 17/01/2011
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Nederlands (NL) (429.54 KB - PDF)

First published: 12/04/2007Last updated: 17/01/2011
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polski (PL) (476.63 KB - PDF)

First published: 12/04/2007Last updated: 17/01/2011
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português (PT) (436.67 KB - PDF)

First published: 12/04/2007Last updated: 17/01/2011
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română (RO) (498.13 KB - PDF)

First published: 12/04/2007Last updated: 17/01/2011
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slovenčina (SK) (474.6 KB - PDF)

First published: 12/04/2007Last updated: 17/01/2011
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slovenščina (SL) (473.16 KB - PDF)

First published: 12/04/2007Last updated: 17/01/2011
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Suomi (FI) (435.82 KB - PDF)

First published: 12/04/2007Last updated: 17/01/2011
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svenska (SV) (436.71 KB - PDF)

First published: 12/04/2007Last updated: 17/01/2011
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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

Avaglim : EPAR - Procedural steps taken and scientific information after authorisation

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Avaglim-H-C-675-A-20-29: EPAR - Assessment Report

AdoptedReference Number: EMA/831387/2010

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Committee for Medicinal Products for Human Use post-authorisation summary of positive opinion for Avaglim on 24 January 2008

Reference Number: EMEA/CHMP/42762/2008

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Avaglim : EPAR - Scientific Discussion

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Avaglim : EPAR - Procedural steps taken before authorisation

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More information on Avaglim

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