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Avandia (rosiglitazone)

Region
🇪🇺 EU
Active substance
rosiglitazone
Company
SmithKline Beecham Plc
Status
Expired
Therapeutic area
Diabetes Mellitus, Type 2
EU approval
Tue 11 Jul 2000
Application
EMEA/H/C/000268
ATC
A10BG02
Official record
www.ema.europa.eu

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).

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.