Byannli (previously Paliperidone Janssen-Cilag International)
paliperidone
Table of contents
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’).
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Byannli (previously Paliperidone Janssen-Cilag International) : EPAR - Medicine overview (PDF/144.5 KB)
First published: 07/07/2020
Last updated: 18/02/2022
EMA/553437/2021 -
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Byannli (previously Paliperidone Janssen-Cilag International) : EPAR - Risk-management-plan summary (PDF/161.7 KB)
First published: 07/07/2020
Last updated: 18/02/2022
Authorisation details
Product details | |
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Name |
Byannli (previously Paliperidone Janssen-Cilag International)
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Agency product number |
EMEA/H/C/005486
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Active substance |
paliperidone palmitate
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International non-proprietary name (INN) or common name |
paliperidone
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Therapeutic area (MeSH) |
Schizophrenia
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Anatomical therapeutic chemical (ATC) code |
N05AX13
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Publication details | |
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Marketing-authorisation holder |
Janssen-Cilag International N.V.
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Revision |
3
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Date of issue of marketing authorisation valid throughout the European Union |
18/06/2020
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Contact address |
Janssen-Cilag International N.V. |
Product information
25/05/2023 Byannli (previously Paliperidone Janssen-Cilag International) - EMEA/H/C/005486 - WS/2405
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
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).