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Esketamine (Spravato) with the positive CHMP opinion for combination treatment in adults with treatment-resistant major depressive disorder

  • 23 October 2019
  • adult, antidepressant, CAP, centralised procedure, CHMP, combination, CP, depression, depressive, disorder, EMA, esketamine, EU, Janssen-Cilag International N.V., MA, MAH, major, marketing authorization, medicinal product, nasal spray solution, SNRI, Spravato, SSRI, TRD, treatment, treatment-resistant,


On 17 October 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Spravato, intended for combination treatment in adults with treatment-resistant major depressive disorder. The applicant for this medicinal product is Janssen-Cilag International N.V.

doctor and girl

Spravato will be available as a 28 mg nasal spray solution. The active substance of Spravato is esketamine, a Psychoanaleptic, Other antidepressants (ATC code: N06AX27).

The full indication is: “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”. Treatment with Spravato should be initiated by psychiatrists to ensure a correct diagnosis of treatment-resistant major depressive disorder.

Product information (PI) on Spravato (esketamine) is available here.

Source: EMA