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Active Substance: rosiglitazone / metformin hydrochloride,
Common Name: rosiglitazone / metformin
ATC Code: A10BD03
Marketing Authorisation Holder: SmithKline Beecham Plc
Active Substance: rosiglitazone / metformin hydrochloride,
Status: Withdrawn
Authorisation Date: 2003-10-20
Therapeutic Area: Diabetes Mellitus, Type 2
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).

The marketing authorisation for Avandamet has expired following the marketing-authorisation holder’s decision not to apply for a renewal.

Source: European Medicines Agency

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