🇪🇺 Alogliptin and pioglitazone in European Union

EMA authorised Alogliptin and pioglitazone on 13 October 2000

Marketing authorisation

EMA — authorised 13 October 2000

  • Application: EMEA/H/C/000285
  • Marketing authorisation holder: CHEPLAPHARM Arzneimittel GmbH
  • Local brand name: Actos
  • Indication: Pioglitazone is indicated in the treatment of type-2 diabetes mellitus: as monotherapy: in patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance; as dual oral therapy in combination with: metformin, in patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin; a sulphonylurea, only in patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemi
  • Status: approved

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Alogliptin and pioglitazone in other countries

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

Frequently asked questions

Is Alogliptin and pioglitazone approved in European Union?

Yes. EMA authorised it on 13 October 2000.

Who is the marketing authorisation holder for Alogliptin and pioglitazone in European Union?

CHEPLAPHARM Arzneimittel GmbH holds the EU marketing authorisation.