Table of contents
This is a summary of the European public assessment report (EPAR) for Adasuve. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Adasuve.
Adasuve : EPAR - Summary for the public (PDF/79.15 KB)
First published: 28/02/2013
Last updated: 28/02/2013
Adasuve : EPAR - Risk-management-plan summary (PDF/114.9 KB)
First published: 31/05/2021
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Ferrer Internacional S.A.
|Date of issue of marketing authorisation valid throughout the European Union||
Gran Via Carlos III
31/10/2022 Adasuve - EMEA/H/C/002400 - II/0033
This medicine’s product information is available in all official EU languages.
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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.
Adasuve is indicated for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. Patients should receive regular treatment immediately after control of acute agitation symptoms.