🇪🇺 Zegalogue in European Union

EMA authorised Zegalogue on 24 July 2024

Marketing authorisation

EMA — authorised 24 July 2024

  • Application: EMEA/H/C/006214
  • Marketing authorisation holder: Zealand Pharma A/S
  • Local brand name: Zegalogue
  • Indication: Zegalogue is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 6 years and over with diabetes mellitus.
  • Status: approved

The EMA has approved Zegalogue, a medication developed by Zealand Pharma A/S, for the treatment of severe hypoglycaemia in patients with diabetes mellitus. This approval was granted on 24 July 2024, following a standard application process. Zegalogue is indicated for use in adults, adolescents, and children aged 6 years and over with diabetes mellitus.

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Zegalogue 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 Zegalogue approved in European Union?

Yes. EMA authorised it on 24 July 2024.

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

Zealand Pharma A/S holds the EU marketing authorisation.