| EMA number | EMEA/H/C/000270 |
| ATC code | A10BG02 |
| Authorisation | 11 July 2000 |
| Withdrawn | 8 December 2004 |
| Revision | 6 |
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.