Avaglim
rosiglitazone / glimepiride
Table of contents
Overview
The marketing authorisation for Avaglim has been withdrawn for safety reasons following a decision by the European Commission.
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
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.