🇪🇺 Zonegran in European Union

EMA authorised Zonegran on 10 March 2005

Marketing authorisations

EMA — authorised 10 March 2005

  • Application: EMEA/H/C/000577
  • Marketing authorisation holder: Amdipharm Limited
  • Local brand name: Zonegran
  • Indication: Zonegran is indicated as: monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy; adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents, and children aged six years and above.
  • Status: approved

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EMA — authorised 31 March 2016

  • Application: EMEA/H/C/004127
  • Marketing authorisation holder: Viatris Limited
  • Local brand name: Zonisamide Viatris (previously Zonisamide Mylan)
  • Indication: Monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy; adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents, and children aged 6 years and above.
  • Status: approved

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Zonegran in other countries

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

Other Neuroscience approved in European Union

Frequently asked questions

Is Zonegran approved in European Union?

Yes. EMA authorised it on 10 March 2005; EMA authorised it on 31 March 2016.

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

Amdipharm Limited holds the EU marketing authorisation.