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 24/01/2018

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
10
Date of issue of marketing authorisation valid throughout the European Union
20/02/2013
Contact address
Gran Via Carlos III, 94
08028 Barcelona
Spain

Product information

15/01/2018 Adasuve - EMEA/H/C/002400 - R/0024

Contents

  • 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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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