Spravato (esketamine)
- Region
- 🇪🇺 EU
- Active substance
- esketamine
- Company
- Janssen-Cilag International NV
- Status
- Authorised
- Therapeutic area
- Depressive Disorder
- CHMP opinion
- Thu 17 Oct 2019
- EU approval
- Wed 18 Dec 2019
- Application
- EMEA/H/C/004535
- ATC
- N06AX27
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.