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Nyracta (rosiglitazone)

Region
🇪🇺 EU
Active substance
rosiglitazone
Company
SmithKline Beecham Plc
Status
Withdrawn
Therapeutic area
Diabetes Mellitus, Type 2
EU approval
Tue 11 Jul 2000
Application
EMEA/H/C/000269
ATC
A10BG02
Official record
www.ema.europa.eu

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.

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.