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Active Substance: rosiglitazone
Common Name: rosiglitazone
ATC Code: A10BG02
Marketing Authorisation Holder: SmithKline Beecham Plc
Active Substance: rosiglitazone
Status: Withdrawn
Authorisation Date: 2000-07-11
Therapeutic Area: Diabetes Mellitus, Type 2
Pharmacotherapeutic Group: Drugs used in diabetes

Therapeutic Indication

Rosiglitazone is indicated as oral monotherapy in type 2 diabetes mellitus patients, particularly overweight patients, inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance.

Rosiglitazone is also indicated for oral combination treatment in type 2 diabetes mellitus patients with insufficient glycaemic control despite maximal tolerated dose of oral monotherapy with either metformin or a sulphonylurea:

  • in combination with metformin particularly in overweight patients.
  • in combination with a sulphonylurea only in patients who show intolerance to metformin or for whom metformin is contraindicated.

The marketing authorisation for Venvia has been withdrawn at the request of the marketing authorisation holder.

Source: European Medicines Agency

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