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Product No EMEA/H/C/000270
Brand Name Venvia
Nonproprietary Name rosiglitazone
API rosiglitazone
ATC Code A10BG02
Indications 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.
Orphan Drug no
Generics no
Marketing Authorization Holder SmithKline Beecham Plc
Status Withdrawn
Authorization Date 2000-07-11
Version 6
Condition Approval no
Exceptions no
Biosimilar no
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