Is Paliperidone registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 17 valid registrations of Paliperidone, including Byannli (700 mg, Prolonged-release suspension for injection, SAR 6947.75); Byannli (1000 mg, Prolonged-release suspension for injection, SAR 8543.50); INVEGA 3MG EXTENDED- RELEASE TABLETS (3 mg, Extended-release tablet, SAR 319.85); INVEGA 6MG EXTENDED- RELEASE TABLETS (6 mg, Extended-release tablet, SAR 319.85); INVEGA 9MG EXTENDED- RELEASE TABLETS (9 mg, Extended-release tablet, SAR 346.70).

Is Paliperidone approved by the US FDA?

Drugs@FDA lists 22 application product lines for Paliperidone, including INVEGA (Prescription); INVEGA (Prescription); INVEGA SUSTENNA (Prescription); INVEGA TRINZA (Prescription); INVEGA HAFYERA (Prescription).

Is Paliperidone authorised in the European Union?

EMA lists 5 centrally authorised medicines containing Paliperidone: Invega, Xeplion, Trevicta (previously Paliperidone Janssen), Byannli (previously Paliperidone Janssen-Cilag International), Niapelf.

Is Paliperidone on the WHO Model List of Essential Medicines?

Yes — 24.1. Medicines for psychotic disorders (core list): Therapeutic equivalent to risperidone for Schizophrenia or other primary psychotic disorders; Schizophrenia or other primary psychotic disorders.

Are there safety signals or safety updates for Paliperidone?

EMA PRAC: 4 entries; US FDA: 4 entries (latest 2025-01-23).

Active substance

Paliperidone

SFDA 18
US FDA 22
EMA 5
Health Canada 11
US price lines 18
NHS prices 11
WHO EML 1
Safety 8

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Byannli	700 mg	Prolonged-release suspension for injection · Intramuscular use	1 Pre-filled syringe	SAR 6947.75	NCE · Prescription	JANSSEN PHARMACEUTICA N.V	Valid
Byannli	1000 mg	Prolonged-release suspension for injection · Intramuscular use	1 Pre-filled syringe	SAR 8543.50	NCE · Prescription	Janssen-Cilag International NV	Valid
INVEGA 3MG EXTENDED- RELEASE TABLETS	3 mg	Extended-release tablet · Oral use	28 Blister	SAR 319.85	NCE · Prescription	JANSSEN-CILAG	Valid
INVEGA 6MG EXTENDED- RELEASE TABLETS	6 mg	Extended-release tablet · Oral use	28 Blister	SAR 319.85	NCE · Prescription	JANSSEN-CILAG	Valid
INVEGA 9MG EXTENDED- RELEASE TABLETS	9 mg	Extended-release tablet · Oral use	28 Blister	SAR 346.70	NCE · Prescription	JANSSEN-CILAG	Valid
INVEGA SUSTENNA 100 mg	100 mg/ml	Prolonged-release suspension for injection · Intramuscular use	1 Pre-filled syringe	SAR 910.50	NCE · Prescription	JANSSEN-CILAG	Valid
INVEGA SUSTENNA 150 mg	100 mg/ml	Prolonged-release suspension for injection · Intramuscular use	1 Pre-filled syringe	SAR 1059.00	NCE · Prescription	JANSSEN-CILAG	Valid
INVEGA SUSTENNA 50 mg	100 mg/ml	Prolonged-release suspension for injection · Intramuscular use	1 Pre-filled syringe	SAR 484.80	NCE · Prescription	JANSSEN-CILAG	Valid
INVEGA SUSTENNA 75 mg	100 mg/ml	Prolonged-release suspension for injection · Intramuscular use	1 Pre-filled syringe	SAR 630.05	NCE · Prescription	JANSSEN-CILAG	Valid
Inveris	150 mg	Suspension for injection in pre-filled syringe · Intramuscular use	1 Pre-filled syringe	SAR 988.30	Generic · Prescription	Pharma Pharmaceutical Industries & Biological Products	Valid
Inveris	100 mg	Suspension for injection in pre-filled syringe · Intramuscular use	1 Pre-filled syringe	SAR 849.45	Generic · Prescription	Pharma Pharmaceutical Industries & Biological Products	Valid
Palipra	6 mg	Prolonged-release tablet · Oral use	30 Blister	SAR 259.85	Generic · Prescription	SPIMACO ADDWAEIH	Valid
Palipra	3 mg	Prolonged-release tablet · Oral use	30 Blister	SAR 259.85	Generic · Prescription	SPIMACO ADDWAEIH	Valid
Trevicta 175 mg prolonged release suspension for injection	175 mg	Prolonged-release suspension for injection · Intramuscular use	1 Pre-filled syringe	SAR 2077.30	NCE · Prescription	JANSSEN PHARMACEUTICA N.V	Valid
Trevicta 263 mg prolonged release suspension for injection	263 mg	Prolonged-release suspension for injection · Intramuscular use	1 Pre-filled syringe	SAR 2561.30	NCE · Prescription	JANSSEN PHARMACEUTICA N.V	Valid
Trevicta 350 mg prolonged release suspension for injection	350 mg	Prolonged-release suspension for injection · Intramuscular use	1 Pre-filled syringe	SAR 2894.90	NCE · Prescription	Janssen-Cilag International NV	Valid
Trevicta 525 mg prolonged release suspension for injection	525 mg	Prolonged-release suspension for injection · Intramuscular use	1 Pre-filled syringe	SAR 3559.80	NCE · Prescription	Janssen-Cilag International NV	Valid
Palipra	9 mg	Prolonged-release tablet · Oral use	30 Blister	SAR 281.65	Generic · Prescription	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

SCHIZOPHRENIA

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
INVEGA	3MG; 6MG; 9MG	tablet, extended release · oral	JANSSEN PHARMS	Prescription	19 Dec 2006
INVEGA	3MG; 6MG; 9MG; 12MG	tablet, extended release · oral	JANSSEN LP	Prescription	27 Apr 2007
INVEGA SUSTENNA	39MG/0.25ML (39MG/0.25ML); 78MG/0.5ML (78MG/0.5ML); 117MG/0.75ML (117MG/0.75ML); 156MG/ML (156MG/ML); 234MG/1.5ML (156MG/ML)	suspension, extended release · intramuscular	JANSSEN PHARMS	Prescription	31 Jul 2009
INVEGA TRINZA	273MG/0.875ML (273MG/0.875ML); 410MG/1.315ML (311.79MG/ML); 546MG/1.75ML (312MG/ML); 819MG/2.625ML (312MG/ML)	suspension, extended release · intramuscular	JANSSEN PHARMS	Prescription	18 May 2015
INVEGA HAFYERA	1.092GM/3.5ML (312MG/ML); 1.560GM/5ML (312MG/ML)	suspension, extended release · intramuscular	JANSSEN PHARMS	Prescription	18 May 2015
PALIPERIDONE	1.5mg; 3MG; 6MG; 9MG	tablet, extended release · oral	SUN PHARM	Prescription	6 Apr 2018
PALIPERIDONE	1.5MG; 3MG; 6MG; 9MG	tablet, extended release · oral	ADAPTIS	Prescription	12 Jun 2019
PALIPERIDONE	1.5MG; 3MG; 6MG; 9MG	tablet, extended release · oral	AMNEAL PHARMS	Prescription	23 Sep 2019
PALIPERIDONE	1.5MG; 3MG; 6MG; 9MG	tablet, extended release · oral	CSPC OUYI	Prescription	29 Oct 2020
PALIPERIDONE	1.5MG; 3MG; 6MG; 9MG	tablet, extended release · oral	ASCENT PHARMS INC	Prescription	23 Aug 2023
PALIPERIDONE	1.5MG; 3MG; 6MG; 9MG	tablet, extended release · oral	AJANTA PHARMA LTD	Prescription	26 Jun 2024
ERZOFRI	39MG/0.25ML (39MG/0.25ML); 78MG/0.5ML (78MG/0.5ML); 117MG/0.75ML (117MG/0.75ML); 156MG/ML (156MG/ML); 234MG/1.5ML (156MG/ML); 351MG/2.25ML (156MG/ML)	suspension, extended release · intramuscular	LUYE INNOMIND PHARMA	Prescription	26 Jul 2024
PALIPERIDONE	1.5MG; 3MG; 6MG; 9MG	tablet, extended release · oral	ALEMBIC	Prescription	26 Sep 2024
PALIPERIDONE	1.5MG; 3MG; 6MG; 9MG	tablet, extended release · oral	ZYDUS PHARMS	Prescription	8 Oct 2024
PALIPERIDONE	3MG; 6MG; 9MG	tablet, extended release · oral	DR REDDYS	Prescription	19 Feb 2025
PALIPERIDONE	1.5MG; 3MG; 6MG; 9MG	tablet, extended release · oral	PHARMAZONE	Prescription	4 Sep 2025
PALIPERIDONE	1.5MG; 3MG; 6MG; 9MG	tablet, extended release · oral	PHARMAZONE	Prescription	7 May 2026
INVEGA	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet, extended release · oral	JANSSEN PHARMS	Discontinued	19 Dec 2006
PALIPERIDONE	1.5MG; 3MG; 6MG; 9MG	tablet, extended release · oral	ACTAVIS LABS FL INC	Discontinued	3 Aug 2015
PALIPERIDONE	1.5MG; 3MG; 6MG; 9MG	tablet, extended release · oral	RK PHARMA	Discontinued	24 Sep 2015
PALIPERIDONE	1.5MG; 3MG; 6MG; 9MG	tablet, extended release · oral	LUPIN	Discontinued	29 Jun 2022
PALIPERIDONE	3MG; 6MG; 9MG	tablet, extended release · oral	APOTEX	Discontinued	26 Jan 2026

EMA European Union — centrally authorised medicines

Invega Janssen-Cilag International NV · Authorised · authorised 24 Jun 2007 · ATC N05AX13

Therapeutic indication (EMA)

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.

Xeplion Janssen-Cilag International · Authorised · authorised 4 Mar 2011 · ATC N05AX13

Therapeutic indication (EMA)

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.

Trevicta (previously Paliperidone Janssen) Janssen-Cilag International NV · Authorised · authorised 5 Dec 2014 · ATC N05AX13

Therapeutic indication (EMA)

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.

Byannli (previously Paliperidone Janssen-Cilag International) · Authorised · authorised 18 Jun 2020 · ATC N05AX13

Therapeutic indication (EMA)

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).

Niapelf Neuraxpharm Pharmaceuticals S.L. · Authorised · authorised 31 Mar 2024 · ATC N05AX13

Therapeutic indication (EMA)

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

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
INVEGA	02300273	3 MG	TABLET (EXTENDED-RELEASE) · ORAL	JANSSEN INC
INVEGA	02300281	6 MG	TABLET (EXTENDED-RELEASE) · ORAL	JANSSEN INC
INVEGA	02300303	9 MG	TABLET (EXTENDED-RELEASE) · ORAL	JANSSEN INC
INVEGA SUSTENNA	02354217	50 MG / 0.5 ML	SUSPENSION (EXTENDED-RELEASE) · INTRAMUSCULAR	JANSSEN INC
INVEGA SUSTENNA	02354225	75 MG / 0.75 ML	SUSPENSION (EXTENDED-RELEASE) · INTRAMUSCULAR	JANSSEN INC
INVEGA SUSTENNA	02354233	100 MG / 1 ML	SUSPENSION (EXTENDED-RELEASE) · INTRAMUSCULAR	JANSSEN INC
INVEGA SUSTENNA	02354241	150 MG / 1.5 ML	SUSPENSION (EXTENDED-RELEASE) · INTRAMUSCULAR	JANSSEN INC
INVEGA TRINZA	02455943	175 MG / 0.875 ML	SUSPENSION (EXTENDED-RELEASE) · INTRAMUSCULAR	JANSSEN INC
INVEGA TRINZA	02455986	263 MG / 1.315 ML	SUSPENSION (EXTENDED-RELEASE) · INTRAMUSCULAR	JANSSEN INC
INVEGA TRINZA	02455994	350 MG / 1.75 ML	SUSPENSION (EXTENDED-RELEASE) · INTRAMUSCULAR	JANSSEN INC
INVEGA TRINZA	02456001	525 MG / 2.625 ML	SUSPENSION (EXTENDED-RELEASE) · INTRAMUSCULAR	JANSSEN INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	INVEGA ER 3 MG TABLET	$12.45301	per EA	2 Jan 2026
US NADAC	INVEGA ER 6 MG TABLET	$12.34881	per EA	23 Sep 2026
US NADAC	INVEGA ER 9 MG TABLET	$18.64123	per EA	23 Sep 2026
US NADAC	INVEGA HAFYERA 1,092 MG/3.5 ML	$4047.70905	per ML	23 Sep 2026
US NADAC	INVEGA HAFYERA 1,560 MG/5 ML	$4233.40151	per ML	2 Jan 2026
US NADAC	INVEGA SUSTENNA 117 MG/0.75 ML	$2339.66855	per ML	23 Sep 2026
US NADAC	INVEGA SUSTENNA 156 MG/ML SYRG	$2337.70833	per ML	23 Sep 2026
US NADAC	INVEGA SUSTENNA 234 MG/1.5 ML	$2338.47458	per ML	23 Sep 2026
US NADAC	INVEGA SUSTENNA 39 MG/0.25 ML	$2338.748	per ML	23 Sep 2026
US NADAC	INVEGA SUSTENNA 78 MG/0.5 ML	$2337.04833	per ML	23 Sep 2026
US NADAC	INVEGA TRINZA 273 MG/0.88 ML	$3950.94887	per ML	23 Sep 2026
US NADAC	INVEGA TRINZA 410 MG/1.32 ML	$3959.46212	per ML	23 Sep 2026
NHS Drug Tariff	Paliperidone 100mg/1ml prolonged-release suspension for injection pre-filled syringes	£314.07	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Paliperidone 150mg/1.5ml prolonged-release suspension for injection pre-filled syringes	£392.59	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Paliperidone 175mg/0.875ml prolonged-release suspension for injection pre-filled syringes	£551.76	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Paliperidone 263mg/1.315ml prolonged-release suspension for injection pre-filled syringes	£734.70	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Paliperidone 350mg/1.75ml prolonged-release suspension for injection pre-filled syringes	£942.21	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Paliperidone 3mg modified-release tablets	£97.28	28 tablet	1 Oct 2026
NHS Drug Tariff	Paliperidone 50mg/0.5ml prolonged-release suspension for injection pre-filled syringes	£183.92	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Paliperidone 525mg/2.625ml prolonged-release suspension for injection pre-filled syringes	£1177.77	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Paliperidone 6mg modified-release tablets	£97.28	28 tablet	1 Oct 2026
NHS Drug Tariff	Paliperidone 75mg/0.75ml prolonged-release suspension for injection pre-filled syringes	£244.90	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Paliperidone 9mg modified-release tablets	£145.92	28 tablet	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

24.1. Medicines for psychotic disorders · core
Therapeutic equivalent to risperidone for Schizophrenia or other primary psychotic disorders; Schizophrenia or other primary psychotic disorders
Parenteral > General injections > IM: 25 mg in pre-filled syringe (as palmitate); 50 mg in pre-filled syringe (as palmitate); 75 mg in pre-filled syringe (as palmitate); 100 mg in pre-filled syringe (as palmitate); 150 mg in pre-filled syringe (as palmitate)

Safety signals and safety-related labeling changes

US FDA 23 Jan 2025 INVEGA TRINZA — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 23 Jan 2025 INVEGA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 23 Jan 2025 INVEGA SUSTENNA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 22 Jan 2025 ERZOFRI — safety-related labeling change
Labeling sections changed: Warnings and Precautions
EMA PRAC 11 Jun 2015 PRAC signal: Acute renal failure
Action for MAH: update of the product information: No
EMA PRAC 12 Feb 2015 PRAC signal: Accidental exposure of children to oral formulation
Action for MAH: update of the product information: No
EMA PRAC 6 Nov 2014 PRAC signal: Acute renal failure
Action for MAH: update of the product information: No
EMA PRAC 11 Sep 2014 PRAC signal: Accidental exposure of children to oral formulation
Action for MAH: update of the product information: No

All safety entries for paliperidone →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.