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
|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||
15/01/2018 Adasuve - EMEA/H/C/002400 - R/0024
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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.