Avandia
Expired
This medicine's authorisation has expired
rosiglitazone
MedicineHumanExpired
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for The marketing authorisation for Avandia (rosiglitazone) expired on 11 July 2015 following the decision of the marketing authorisation holder, Smithkline Beecham Ltd., not to apply for a renewal of the marketing authorisation. The marketing authorisation for Avandia in the European Union (EU) was suspended at that time.
Avandia was granted marketing authorisation in the European Union (EU) on 11 July 2000 for treatment of type 2 diabetes mellitus treatment of type 2 diabetes mellitus treatment of type 2 diabetes mellitus treatment of type 2 diabetes mellitus. The marketing authorisation was valid for a 5-year period. It was subsequently renewed for additional 5-year periods on 08 July 2005 and on 26 May 2009.
The European Public Assessment Report (EPAR) for Avandia is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.has expired following the marketing-authorisation holder’s decision not to apply for a renewal.
Product information
Latest procedure affecting product information:A20/0075
03/12/2010
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).
Product details
- Name of medicine
- Avandia
- 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
Pharmacotherapeutic group
Drugs used in diabetesTherapeutic 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).
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