Adasuve

RSS

loxapine

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

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.

This EPAR was last updated on 14/11/2022

Authorisation details

Product details
Name
Adasuve
Agency product number
EMEA/H/C/002400
Active substance
loxapine
International non-proprietary name (INN) or common name
loxapine
Therapeutic area (MeSH)
  • Schizophrenia
  • Bipolar Disorder
Anatomical therapeutic chemical (ATC) code
N05AH01
Publication details
Marketing-authorisation holder
Ferrer Internacional S.A.
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
20/02/2013
Contact address

Gran Via Carlos III
94 E-08028 Barcelona
Spain

Product information

31/10/2022 Adasuve - EMEA/H/C/002400 - II/0033

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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

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.

Assessment history

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