Avandamet
rosiglitazone / metformin
Table of contents
Overview
The marketing authorisation for Avandamet has expired following the marketing-authorisation holder’s decision not to apply for a renewal.
Authorisation details
| Product details | |
|---|---|
| Name |
Avandamet
|
| Agency product number |
EMEA/H/C/000522
|
| Active substance |
|
| International non-proprietary name (INN) or common name |
|
| Therapeutic area (MeSH) |
Diabetes Mellitus, Type 2
|
| Anatomical therapeutic chemical (ATC) code |
A10BD03
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
SmithKline Beecham Plc
|
| Revision |
16
|
| Date of issue of marketing authorisation valid throughout the European Union |
20/10/2003
|
| Contact address |
SmithKline Beecham plc
980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom |
Product information
03/12/2010 Avandamet - EMEA/H/C/000522 - A20/0063
This medicine’s product information is available in all official EU languages.
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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).
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
AVANDAMET is indicated in the treatment of type 2 diabetes mellitus patients, particularly overweight patients:
- who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.
- in triple oral therapy with sulphonylurea in patients with insufficient glycaemic control despite dual oral therapy with their maximally tolerated dose of metformin and a sulphonylurea (see section 4.4).