Adasuve
loxapine
Table of contents
Overview
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.
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List item
Adasuve : EPAR - Summary for the public (PDF/79.15 KB)
First published: 28/02/2013
Last updated: 28/02/2013
EMA/116425/2013 -
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Adasuve : EPAR - Risk-management-plan summary (PDF/114.9 KB)
First published: 31/05/2021
Authorisation details
Product details | |
---|---|
Name |
Adasuve
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Agency product number |
EMEA/H/C/002400
|
Active substance |
loxapine
|
International non-proprietary name (INN) or common name |
loxapine
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
N05AH01
|
Publication details | |
---|---|
Marketing-authorisation holder |
Ferrer Internacional S.A.
|
Revision |
14
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Date of issue of marketing authorisation valid throughout the European Union |
20/02/2013
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Contact address |
Gran Via Carlos III |
Product information
31/10/2022 Adasuve - EMEA/H/C/002400 - II/0033
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
Nervous system
Therapeutic indication
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.