🇪🇺 Sulfonylureas in European Union

EMA authorised Sulfonylureas on 24 May 2018

Marketing authorisation

EMA — authorised 24 May 2018

  • Application: EMEA/H/C/004379
  • Marketing authorisation holder: Ammtek
  • Local brand name: Amglidia
  • Indication: Amglidia is indicated for the treatment of neonatal diabetes mellitus, for use in newborns, infants and children. Sulphonylureas like Amglidia have been shown to be effective in patients with mutations in the genes coding for the ?-cell ATP-sensitive potassium channel and chromosome 6q24-related transient neonatal diabetes mellitus.
  • Pathway: orphan
  • Status: approved

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Sulfonylureas 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 Sulfonylureas approved in European Union?

Yes. EMA authorised it on 24 May 2018.

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

Ammtek holds the EU marketing authorisation.