Spravato

RSS

esketamine

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 31/08/2022

Authorisation details

Product details
Name
Spravato
Agency product number
EMEA/H/C/004535
Active substance
esketamine hydrochloride
International non-proprietary name (INN) or common name
esketamine
Therapeutic area (MeSH)
Depressive Disorder
Anatomical therapeutic chemical (ATC) code
N06AX27
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Janssen-Cilag International NV
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
18/12/2019
Contact address

Turnhoutseweg 30
B-2340 Beerse
Belgium

Product information

23/08/2022 Spravato - EMEA/H/C/004535 - IAIN/0015

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Other antidepressants

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.

Assessment history

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