Is Palonosetron registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 5 valid registrations of Palonosetron, including ALOXI 0.25 mg/ 5 ml Solution For Injection (0.05 mg/ml, Solution for injection, SAR 139.00); Emedius (0.05 mg/ml, Solution for injection, SAR 695.00); Etalon 0.25 mg per 5 ml (0.05 mg/ml, Solution for injection, SAR 139.00); SERONORM 0.075 mg solution for IV injection (0.05 mg/ml, Solution for injection, SAR 69.05); SERONORM 0.25 mg solution for IV injection (0.05 mg/ml, Solution for injection, SAR 207.15).

Is Palonosetron approved by the US FDA?

Drugs@FDA lists 28 application product lines for Palonosetron, including PALONOSETRON HYDROCHLORIDE (Prescription); POSFREA (Prescription); PALONOSETRON HYDROCHLORIDE (Prescription); PALONOSETRON HYDROCHLORIDE (Prescription); PALONOSETRON HYDROCHLORIDE (Prescription).

Is Palonosetron authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Palonosetron: Aloxi, Palonosetron Accord.

Is Palonosetron on the WHO Model List of Essential Medicines?

Yes — 2.3. Medicines for other common symptoms in palliative care (core list): Therapeutic equivalent to ondansetron for Palliative care.

Are there safety signals or safety updates for Palonosetron?

US FDA: 5 entries (latest 2025-04-16).

Active substance

Palonosetron

SFDA 5
US FDA 28
EMA 3
Health Canada 1
WHO EML 2
Safety 5

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ALOXI 0.25 mg/ 5 ml Solution For Injection	0.05 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 139.00	NCE · Prescription	HELSINN BIREX PHARMACEUTICAL Ltd	Valid
Emedius	0.05 mg/ml	Solution for injection · Intravenous use	5 Ampoule	SAR 695.00	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
Etalon 0.25 mg per 5 ml	0.05 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 139.00	Generic · Prescription	Advanced Pharmaceutical Industries	Valid
SERONORM 0.075 mg solution for IV injection	0.05 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 69.05	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
SERONORM 0.25 mg solution for IV injection	0.05 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 207.15	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid

Indications — CHI Daman Drug Formulary

MENSTRUAL DISORDERS; NAUSEA AND VOMITING IN CANCER

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

Product	Strength	Form · route	Applicant	Status	First approved
PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	injectable · intravenous	SANDOZ	Prescription	13 Oct 2015
POSFREA	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	solution · intravenous	AVYXA HOLDINGS	Prescription	1 Mar 2016
PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	injectable · intravenous	DR REDDYS	Prescription	21 Apr 2016
PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	injectable · intravenous	TEVA PHARMS USA	Prescription	23 Mar 2018
PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	injectable · intravenous	SAGENT PHARMS INC	Prescription	19 Sep 2018
PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	injectable · intravenous	QILU PHARM HAINAN	Prescription	19 Sep 2018
PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	injectable · intravenous	SAGENT PHARMS INC	Prescription	19 Sep 2018
PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	injectable · intravenous	MYLAN INSTITUTIONAL	Prescription	19 Sep 2018
PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	injectable · intravenous	FRESENIUS KABI USA	Prescription	19 Sep 2018
PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	injectable · intravenous	FRESENIUS KABI USA	Prescription	19 Sep 2018
PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	injectable · intravenous	HOSPIRA	Prescription	19 Sep 2018
PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	injectable · intravenous	CHARTWELL RX	Prescription	19 Sep 2018
PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	injectable · intravenous	EUGIA PHARMA	Prescription	6 Nov 2018
PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML); EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	injectable · intravenous	AVET LIFESCIENCES	Prescription	29 Jun 2021
PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	injectable · intravenous	MEITHEAL	Prescription	14 Aug 2023
ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · intravenous	HELSINN HLTHCARE	Discontinued	25 Jul 2003
ALOXI	EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	capsule · oral	HELSINN HLTHCARE	Discontinued	22 Aug 2008
POSFREA	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	solution · intravenous	AVYXA HOLDINGS	Discontinued	1 Mar 2016
PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	injectable · intravenous	DR REDDYS	Discontinued	21 Apr 2016
PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	solution · intravenous	HIKMA	Discontinued	22 Aug 2016
PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	solution · intravenous	FRESENIUS KABI USA	Discontinued	21 Nov 2017
PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	injectable · intravenous	TEVA PHARMS USA	Discontinued	23 Mar 2018
PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	injectable · intravenous	QILU PHARM HAINAN	Discontinued	19 Sep 2018
PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	injectable · intravenous	CIPLA	Discontinued	19 Sep 2018
PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	injectable · intravenous	HOSPIRA	Discontinued	19 Sep 2018

3 more — full table

EMA European Union — centrally authorised medicines

Aloxi Helsinn Birex Pharmaceuticals Ltd. · Authorised · authorised 22 Mar 2005 · ATC A04AA05

Therapeutic indication (EMA)

Aloxi is indicated in adults for: the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy, the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. Aloxi is indicated in paediatric patients 1 month of age and older for: the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

Palonosetron Accord Accord Healthcare S.L.U. · Authorised · authorised 26 May 2016 · ATC A04AA05

Therapeutic indication (EMA)

Palonosetron Accord is indicated in adults for: the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy, the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. Palonosetron Accord is indicated in paediatric patients 1 month of age and older for: The prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

Palonosetron Hospira Pfizer Europe MA EEIG · Withdrawn · authorised 8 Apr 2016 · ATC A04AA05

Therapeutic indication (EMA)

Palonosetron Hospira is indicated in adults for: the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy; the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. Palonosetron Hospira is indicated in paediatric patients 1 month of age and older for: the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ALOXI	02381710	0.25 MG / 5 ML	SOLUTION · INTRAVENOUS	KNIGHT THERAPEUTICS INC.

WHO WHO Model List of Essential Medicines (2025)

2.3. Medicines for other common symptoms in palliative care · core
Therapeutic equivalent to ondansetron for Palliative care
17.2. Antiemetic medicines · core
Therapeutic equivalent to ondansetron for Nausea or vomiting

Safety signals and safety-related labeling changes

US FDA 16 Apr 2025 POSFREA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 2 Jun 2021 AKYNZEO — safety-related labeling change
Labeling sections changed: Patient Counseling Information / Patient Information / Medication Guide
US FDA 1 Apr 2020 ALOXI — 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 1 Apr 2020 ALOXI — 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 6 Dec 2018 PALONOSETRON HYDROCHLORIDE — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations

All safety entries for palonosetron →

Combinations containing Palonosetron

Netupitant + palonosetron

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.