Avandamet (rosiglitazone;metformin)
- Region
- 🇪🇺 EU
- Active substance
- rosiglitazone;metformin
- Company
- SmithKline Beecham Plc
- Status
- Expired
- Therapeutic area
- Diabetes Mellitus, Type 2
- EU approval
- Mon 20 Oct 2003
- Application
- EMEA/H/C/000522
- ATC
- A10BD03
- Official record
- www.ema.europa.eu
Indication
AVANDAMET is indicated in the treatment of type 2 diabetes mellitus patients, particularly overweight patients: who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone. in triple oral therapy with sulphonylurea in patients with insufficient glycaemic control despite dual oral therapy with their maximally tolerated dose of metformin and a sulphonylurea (see section 4.4).
Regulatory milestones
No milestones recorded in the last year.
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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.