Is Netupitant + Palonosetron registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Netupitant + Palonosetron, including AKYNZEO 300 mg/0.5 mg hard capsules (300,0.5 mg,mg, Capsule, hard, SAR 306.70).

Is Netupitant + Palonosetron approved by the US FDA?

Drugs@FDA lists 1 application product line for Netupitant + Palonosetron, including AKYNZEO (Prescription).

Is Netupitant + Palonosetron authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Netupitant + Palonosetron: Akynzeo.

Active substances

Netupitant + Palonosetron

SFDA 1
US FDA 1
EMA 1
Health Canada 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
AKYNZEO 300 mg/0.5 mg hard capsules	300,0.5 mg,mg	Capsule, hard · Oral use	1 Blister	SAR 306.70	NCE · Prescription	Helsinn Birex Pharmaceuticals Ltd	Valid

Indications — CHI Daman Drug Formulary

NAUSEA AND VOMITING IN CANCER

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

Product	Strength	Form · route	Applicant	Status	First approved
AKYNZEO	300MG;EQ 0.5MG BASE	capsule · oral	HELSINN HLTHCARE	Prescription	10 Oct 2014

EMA European Union — centrally authorised medicines

Akynzeo Helsinn Birex Pharmaceuticals Ltd · Authorised · authorised 27 May 2015 · ATC A04AA

Therapeutic indication (EMA)

Akynzeo is indicated in adults for the: Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy. Prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AKYNZEO	02468735	0.5 MG; 300 MG	CAPSULE · ORAL	KNIGHT THERAPEUTICS INC.

Components

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.