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EMA Product

Spravato

Product approved by European Medicines Agency (EU)

Basic Information

Spravato

Regulatory Information

EMEA/H/C/004535

Authorised

December 18, 2019

October 17, 2019

15

September 4, 2024

Company Information

Belgium

Turnhoutseweg 30 B-2340 Beerse

Janssen-Cilag International NV

Active Ingredients

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic 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.

Overview Summary

Spravato is a medicine used to treat adults with major depression that is resistant to treatment. It is used in combination with an SSRI or SNRI medicine (other antidepressants) when at least two other treatments have failed. Spravato contains the active substance esketamine.

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