Spravato
esketamine
Table of contents
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.
-
List item
Spravato : EPAR - Medicine overview (PDF/123.14 KB)
First published: 19/12/2019
EMA/578240/2019 -
-
List item
Spravato : EPAR - Risk-management-plan summary (PDF/160.48 KB)
First published: 19/12/2019
Last updated: 06/07/2021
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 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 |
8
|
Date of issue of marketing authorisation valid throughout the European Union |
18/12/2019
|
Contact address |
Turnhoutseweg 30 |
Product information
04/07/2023 Spravato - EMEA/H/C/004535 - IB/0019/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
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.