Trevicta (previously Paliperidone Janssen)

RSS

paliperidone

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

Overview

This is a summary of the European public assessment report (EPAR) for Trevicta. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Trevicta.

For practical information about using Trevicta, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 19/10/2018

Authorisation details

Product details
Name
Trevicta (previously Paliperidone Janssen)
Agency product number
EMEA/H/C/004066
Active substance
paliperidone palmitate
International non-proprietary name (INN) or common name
paliperidone
Therapeutic area (MeSH)
Schizophrenia
Anatomical therapeutic chemical (ATC) code
N05AX13
Publication details
Marketing-authorisation holder
Janssen-Cilag International NV
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
04/12/2014
Contact address
Turnhoutseweg 30
2340 Beerse
Belgium

Product information

12/09/2018 Trevicta (previously Paliperidone Janssen) - EMEA/H/C/004066 - WS/1417/G

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

PSYCHOLEPTICS

Therapeutic indication

Trevicta, a 3 monthly injection, is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1 monthly paliperidone palmitate injectable product.

Assessment history

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