🇪🇺 Avandamet in European Union

EMA authorised Avandamet on 20 October 2003

Marketing authorisation

EMA — authorised 20 October 2003

  • Application: EMEA/H/C/000522
  • Marketing authorisation holder: SmithKline Beecham Plc
  • Local brand name: Avandamet
  • 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).
  • Status: withdrawn

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Avandamet in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in European Union

Frequently asked questions

Is Avandamet approved in European Union?

Yes. EMA authorised it on 20 October 2003.

Who is the marketing authorisation holder for Avandamet in European Union?

SmithKline Beecham Plc holds the EU marketing authorisation.