Xeplion

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 Xeplion. 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 Xeplion.

This EPAR was last updated on 17/10/2018

Authorisation details

Product details
Name
Xeplion
Agency product number
EMEA/H/C/002105
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 N.V.
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
04/03/2011
Contact address
Turnhoutseweg 30
BE-2340 Beerse
Belgium

Product information

13/09/2018 Xeplion - EMEA/H/C/002105 - WS/1417/G

Contents

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

Xeplion is indicated for maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone.

In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, Xeplion may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.

Assessment history

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