Avandamet
Expired
This medicine's authorisation has expired
rosiglitazone / metformin
MedicineHumanExpired
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Avandamet (rosiglitazone/metformin) expired on 20 October 2013 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 Avandamet in the European Union (EU) was suspended at that time.
Avandamet was granted marketing authorisation in the European Union (EU) on 20 October 2003 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 an additional 5-year period on 13 August 2008.
The European Public Assessment Report (EPAR) for Avandamet is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:A20/0063
03/12/2010
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).
Product details
- Name of medicine
- Avandamet
- Active substance
- rosiglitazone
- metformin hydrochloride
- International non-proprietary name (INN) or common name
- rosiglitazone
- metformin
- Therapeutic area (MeSH)
- Diabetes Mellitus, Type 2
- Anatomical therapeutic chemical (ATC) code
- A10BD03
Pharmacotherapeutic group
Drugs used in diabetesTherapeutic 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).
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