🇪🇺 Albugon in European Union

EMA authorised Albugon on 20 March 2014

Marketing authorisation

EMA — authorised 20 March 2014

  • Application: EMEA/H/C/002735
  • Marketing authorisation holder: GlaxoSmithKline Trading Services Limited
  • Local brand name: Eperzan
  • Indication: Eperzan is indicated for the treatment of type 2 diabetes mellitus in adults to improve glycaemic control as: Monotherapy When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to contraindications or intolerance. Add-on combination therapy In combination with other glucose-lowering medicinal products including basal insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see section 4.4 and 5.1 for available data on different combinations).
  • Status: withdrawn

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Albugon in other countries

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

Other Metabolic approved in European Union

Frequently asked questions

Is Albugon approved in European Union?

Yes. EMA authorised it on 20 March 2014.

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

GlaxoSmithKline Trading Services Limited holds the EU marketing authorisation.