Invega
paliperidone
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Invega. 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 Invega.
For practical information about using Invega, patients should read the package leaflet or contact their doctor or pharmacist.
-
List item
Invega : EPAR - Summary for the public (PDF/80.9 KB)
First published: 04/03/2009
Last updated: 19/09/2017 -
-
List item
Invega : EPAR - Risk-management-plan summary (PDF/88.97 KB)
First published: 13/08/2020
Authorisation details
Product details | |
---|---|
Name |
Invega
|
Agency product number |
EMEA/H/C/000746
|
Active substance |
paliperidone
|
International non-proprietary name (INN) or common name |
paliperidone
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
N05AX13
|
Publication details | |
---|---|
Marketing-authorisation holder |
Janssen-Cilag International NV
|
Revision |
18
|
Date of issue of marketing authorisation valid throughout the European Union |
24/06/2007
|
Contact address |
Turnhoutseweg, 30 |
Product information
09/04/2021 Invega - EMEA/H/C/000746 - WS/1877
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
Psycholeptics
Therapeutic indication
Invega is indicated for the treatment of schizophrenia in adults and in adolescents 15 years and older.
Invega is indicated for the treatment of schizoaffective disorder in adults.