Byannli (previously Paliperidone Janssen-Cilag International)

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paliperidone

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

Overview

Byannli (previously Paliperidone Janssen-Cilag International) is an antipsychotic medicine used for the maintenance treatment of schizophrenia in adults whose disease has already been stabilised on treatment with injections of paliperidone given every month or every three months.


Byannli contains the active substance paliperidone.


This medicine is similar to Xeplion and Trevicta, which are already authorised in the EU, but are available in different strengths. Scientific data from Xeplion was used during the initial authorisation of Byannli (‘informed consent’).

This EPAR was last updated on 18/02/2022

Authorisation details

Product details
Name
Byannli (previously Paliperidone Janssen-Cilag International)
Agency product number
EMEA/H/C/005486
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
2
Date of issue of marketing authorisation valid throughout the European Union
18/06/2020
Contact address

Janssen-Cilag International N.V.
Turnhoutseweg 30
BE-2340 Beerse
Belgium

Product information

22/11/2021 Byannli (previously Paliperidone Janssen-Cilag International) - EMEA/H/C/005486 - X/0002/G

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

Psycholeptics

Therapeutic indication

Byannli (previously Paliperidone Janssen-Cilag International) a 6 monthly injection, is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1 monthly or 3 monthly paliperidone palmitate injectable products (see section 5.1).

Assessment history

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