Avandia
rosiglitazone
Table of contents
Overview
The marketing authorisation for Avandia has expired following the marketing-authorisation holder’s decision not to apply for a renewal.
Authorisation details
| Product details | |
|---|---|
| Name |
Avandia
|
| Agency product number |
EMEA/H/C/000268
|
| Active substance |
rosiglitazone
|
| International non-proprietary name (INN) or common name |
rosiglitazone
|
| Therapeutic area (MeSH) |
Diabetes Mellitus, Type 2
|
| Anatomical therapeutic chemical (ATC) code |
A10BG02
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
SmithKline Beecham Plc
|
| Revision |
23
|
| Date of issue of marketing authorisation valid throughout the European Union |
11/07/2000
|
| Contact address |
SmithKline Beecham plc
980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom |
Product information
03/12/2010 Avandia - EMEA/H/C/000268 - A20/0075
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
Rosiglitazone is indicated in the treatment of type 2 diabetes mellitus:
as monotherapy
-in patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance
as dual oral therapy in combination with
-metformin, in patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin
-a sulphonylurea, only in patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite monotherapy with a sulphonylurea
as triple oral therapy in combination with
-metformin and a sulphonylurea, in patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy (see section 4.4).