🇪🇺 Esketamine Nasal Spray [Spravato] in European Union

EMA authorised Esketamine Nasal Spray [Spravato] on 18 December 2019

Marketing authorisation

EMA — authorised 18 December 2019

  • Application: EMEA/H/C/004535
  • Marketing authorisation holder: Janssen-Cilag International NV
  • Local brand name: Spravato
  • Indication: Spravato, in combination with a SSRI or SNRI, is indicated for adults with treatment-resistant Major Depressive Disorder, who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode.
  • Status: approved

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Other Psychiatry approved in European Union

Frequently asked questions

Is Esketamine Nasal Spray [Spravato] approved in European Union?

Yes. EMA authorised it on 18 December 2019.

Who is the marketing authorisation holder for Esketamine Nasal Spray [Spravato] in European Union?

Janssen-Cilag International NV holds the EU marketing authorisation.