Paliperidone
Also known as: Invega · Xeplion · Trevicta (previously Paliperidone Janssen) · Byannli (previously Paliperidone Janssen-Cilag International) · Niapelf
General information only. Anpheros does not diagnose and does not recommend treatment. Talk to a doctor or pharmacist about your situation. In an emergency, call 112 (or your local emergency number).
In short
In the European Union, paliperidone is indicated for the treatment of schizophrenia in adults and adolescents aged 15 years and older, and for the treatment of schizoaffective disorder in adults. In the European Union, specific injectable formulations of paliperidone are indicated for the maintenance treatment of schizophrenia in clinically stable or stabilised adult patients. In the United States, paliperidone is an atypical antipsychotic agent indicated for the treatment of schizophrenia in adults and adolescents aged 12 to 17, and for the treatment of schizoaffective disorder as monotherapy or as an adjunct to mood stabilizers and/or antidepressants. Paliperidone is also listed by cited sources as having an approved use for schizophrenia.
From: Source: European Medicines Agency (EMA), Invega — EPAR, 12/07/2024. © European Medicines Agency. · Source: European Medicines Agency (EMA), Byannli (previously Paliperidone Janssen-Cilag International) — EPAR, 10/06/2026. © European Medicines Agency. · Source: European Medicines Agency (EMA), Trevicta (previously Paliperidone Janssen) — EPAR, 22/07/2024. © European Medicines Agency. · Source: European Medicines Agency (EMA), Xeplion — EPAR, 03/06/2026. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration. · Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.
Codes
- RxNorm
- 679314 paliperidone
- EMA
- EMEA/H/C/000746, EMEA/H/C/002105, EMEA/H/C/004066, EMEA/H/C/005486, EMEA/H/C/006185
Official indications
Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.
EMA (EU) Byannli (previously Paliperidone Janssen-Cilag International)
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).
Source: European Medicines Agency (EMA), Byannli (previously Paliperidone Janssen-Cilag International) — EPAR, 10/06/2026. © European Medicines Agency.
Document date: 10/06/2026 · Official document →
EMA (EU) Invega
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.
Source: European Medicines Agency (EMA), Invega — EPAR, 12/07/2024. © European Medicines Agency.
Document date: 12/07/2024 · Official document →
FDA (USA) PALIPERIDONE
1. INDICATIONS AND USAGE Paliperidone is an atypical antipsychotic agent indicated for Treatment of schizophrenia ( 1.1 ) Adults: Efficacy was established in three 6-week trials and one maintenance trial. ( 14.1 ) Adolescents (ages 12-17): Efficacy was established in one 6-week trial. ( 14.1 ) Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants. ( 1.2 ) Efficacy was established in two 6-week trials in adult patients. ( 14.2 ) 1.1 Schizophrenia Paliperidone extended-release tablets are indicated for the treatment of schizophrenia [see Clinical Studies (14.1) ]. The efficacy of paliperidone in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults. 1.2 Schizoaffective Disorder Paliperidone extended-release tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy [see Clinical Studies (14.2) ]. The efficacy of paliperidone in schizoaffective disorder was established in two 6-week trials in adults.
Data provided by the U.S. Food and Drug Administration.
Document date: 20260728 · Official document →
EMA (EU) Trevicta (previously Paliperidone Janssen)
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.
Source: European Medicines Agency (EMA), Trevicta (previously Paliperidone Janssen) — EPAR, 22/07/2024. © European Medicines Agency.
Document date: 22/07/2024 · Official document →
EMA (EU) Xeplion
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.
Source: European Medicines Agency (EMA), Xeplion — EPAR, 03/06/2026. © European Medicines Agency.
Document date: 03/06/2026 · Official document →
Related terms in the cited sources
Has an official indication for
- Schizophrenia Condition
In alphabetical order.
Other treatments A–Z
What people report
Not enough data yet. Anonymous counts appear here only for groups of at least 20 people who agreed to share them.
External resources
Questions
What is Paliperidone approved for in the European Union?
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). (Source: European Medicines Agency (EMA), Byannli (previously Paliperidone Janssen-Cilag International) — EPAR, 10/06/2026. © European Medicines Agency.)
Sources and attribution
- Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
- Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
- Data provided by the U.S. Food and Drug Administration.
- This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
- Source: European Medicines Agency (EMA), Byannli (previously Paliperidone Janssen-Cilag International) — EPAR, 10/06/2026. © European Medicines Agency.
- Source: European Medicines Agency (EMA), Invega — EPAR, 12/07/2024. © European Medicines Agency.
- Source: European Medicines Agency (EMA), Trevicta (previously Paliperidone Janssen) — EPAR, 22/07/2024. © European Medicines Agency.
- Source: European Medicines Agency (EMA), Xeplion — EPAR, 03/06/2026. © European Medicines Agency.
Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →
About this page. This page brings together public information from official sources, each cited where it is used. It is not medical advice, it is not a diagnosis, and it does not tell you which treatment to take.
Treatments. Indications are quoted unchanged from official product information (European Medicines Agency, U.S. Food and Drug Administration). They describe what a medicine is approved for, not whether it is right for you. Approved uses can differ between countries. Always read the package leaflet and follow your doctor's or pharmacist's advice.
What people report. Figures marked "reported by Anpheros users" are anonymous counts from at least 20 people who agreed to share them. They show what people report, not what works, and they are not clinical evidence.
Links between terms. "May be associated with" means the link appears in a cited source. It does not mean you have that condition.
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