Avaglim
rosiglitazone / glimepiride
Table of contents
Withdrawn
This medicine is now withdrawn from use in the European Union.
Overview
The marketing authorisation for Avaglim has been withdrawn for safety reasons following a decision by the European Commission.
This EPAR was last updated on 12/08/2011
Authorisation details
| Product details | |
|---|---|
| Name |
Avaglim
|
| Agency product number |
EMEA/H/C/000675
|
| Active substance |
|
| International non-proprietary name (INN) or common name |
|
| Therapeutic area (MeSH) |
Diabetes Mellitus, Type 2
|
| Anatomical therapeutic chemical (ATC) code |
A10BD04
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
SmithKline Beecham Ltd
|
| Revision |
11
|
| Date of issue of marketing authorisation valid throughout the European Union |
27/06/2006
|
| Contact address |
980 Great West Road
Brentford Middlesex TW8 9GS United Kingdom |
Product information
26/07/2011 Avaglim - EMEA/H/C/000675 - A20/0029
Contents
- 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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Pharmacotherapeutic group
Pharmacotherapeutic group
Drugs used in diabetes
Therapeutic indication
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.