Is Granisetron registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 6 valid registrations of Granisetron, including EMLOP 1MG/ML AMPOULE (1 mg/ml, Solution for injection/infusion, SAR 31.05); GRANITRON 1MG-ML SOLUTION FOR Injection (1 mg/ml, Solution for injection, SAR 130.40); GRANITRON 3MG-3ML SOLUTION FOR Injection (1 mg/ml, Solution for injection, SAR 232.50); KYTRIL 1MG TAB (1 mg, Tablet, SAR 165.85); KYTRIL 1MG-ML AMP (1 mg/ml, Injection, SAR 145.75).

Is Granisetron approved by the US FDA?

Drugs@FDA lists 54 application product lines for Granisetron, including GRANISETRON HYDROCHLORIDE (Prescription); GRANISETRON HYDROCHLORIDE (Prescription); GRANISETRON HYDROCHLORIDE (Prescription); GRANISETRON HYDROCHLORIDE (Prescription); GRANISETRON HYDROCHLORIDE (Prescription).

Is Granisetron authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Granisetron: Sancuso.

Is Granisetron 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 Granisetron?

US FDA: 2 entries (latest 2026-02-23).

Active substance

Granisetron

SFDA 10
US FDA 54
EMA 1
Health Canada 3
US price lines 2
NHS prices 3
WHO EML 2
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
EMLOP 1MG/ML AMPOULE	1 mg/ml	Solution for injection/infusion · Intravenous use	3 Ampoule	SAR 31.05	Generic · Prescription	Amoun Pharmaceutical Company	Valid
GRANITRON 1MG-ML SOLUTION FOR Injection	1 mg/ml	Solution for injection · Intravenous use	5 Ampoule	SAR 130.40	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
GRANITRON 3MG-3ML SOLUTION FOR Injection	1 mg/ml	Solution for injection · Intravenous use	5 Ampoule	SAR 232.50	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
KYTRIL 1MG TAB	1 mg	Tablet · Oral use	10 Blister	SAR 165.85	NCE · Prescription	Atnahs Pharma UK Limited	Valid
KYTRIL 1MG-ML AMP	1 mg/ml	Injection · Intravenous use	5 Ampoule	SAR 145.75	NCE · Prescription	Atnahs Pharma UK Limited	Valid
SANCUSO 34.3 mg transdermal patch	34.3 mg	Transdermal patch · Topical	1 Pouch	SAR 408.35	NCE · Prescription	Kyowa Kirin Holdings B.V.	Valid
KYTRIL 1MG TAB	1 mg	Tablet · Oral use	10 Blister	SAR 174.55	NCE · Prescription	ROCHE	Withdrawn by MAH · Not Marketed
KYTRIL 1MG-ML AMP	1 mg/ml	Solution · Intravenous use	5 Ampoule	SAR 153.40	NCE · Prescription	ROCHE	Withdrawn by MAH · Not Marketed
KYTRIL 200MCG-ML SYRUP	200 µ/ml	Syrup · Oral use	1 Bottle	SAR 217.90	NCE · Prescription	ROCHE	Withdrawn by MAH · Not Marketed
KYTRIL 3MG-3ML AMP	1 mg/ml	Injection · Intravenous use	5 Ampoule	SAR 467.30	NCE · Prescription	ROCHE	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ANXIETY DISORDERS; NAUSEA AND VOMITING IN CANCER; VIRAL GASTROENTERITIS

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

Product	Strength	Form · route	Applicant	Status	First approved
GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	injectable · injection	HIKMA PHARMS	Prescription	31 Dec 2007
GRANISETRON HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	injectable · injection	AMNEAL	Prescription	31 Dec 2007
GRANISETRON HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	injectable · injection	DR REDDYS	Prescription	31 Dec 2007
GRANISETRON HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	injectable · injection	FRESENIUS KABI USA	Prescription	31 Dec 2007
GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	tablet · oral	ORBION PHARMS	Prescription	13 Feb 2008
GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	tablet · oral	CHARTWELL MOLECULAR	Prescription	27 Feb 2008
GRANISETRON HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	injectable · injection	HIKMA PHARMS	Prescription	26 Jun 2008
GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	injectable · injection	HIKMA PHARMS	Prescription	30 Jun 2008
GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	injectable · injection	HIKMA PHARMS	Prescription	30 Jun 2008
GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	injectable · injection	DR REDDYS	Prescription	30 Jun 2008
GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	injectable · injection	FRESENIUS KABI USA	Prescription	30 Jun 2008
GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	injectable · injection	FRESENIUS KABI USA	Prescription	30 Jun 2008
GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML); EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	injectable · injection	AMNEAL	Prescription	30 Jun 2008
GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML); EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	injectable · injection	SANDOZ INC	Prescription	30 Jun 2008
GRANISETRON HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	injectable · injection	BIONPHARMA	Prescription	30 Jun 2008
GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	injectable · injection	BIONPHARMA	Prescription	30 Jun 2008
GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	injectable · injection	BIONPHARMA	Prescription	30 Jun 2008
SANCUSO	3.1MG/24HR	film, extended release · transdermal	APOTEX	Prescription	12 Sep 2008
GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	tablet · oral	DR REDDYS LABS LTD	Prescription	27 Feb 2009
GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML); EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	injectable · injection	SANDOZ	Prescription	30 Apr 2009
GRANISETRON HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	injectable · injection	SANDOZ	Prescription	30 Apr 2009
GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	tablet · oral	NATCO PHARMA	Prescription	22 Jun 2009
GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML); EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	injectable · injection	RISING	Prescription	14 Sep 2009
GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML); EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	injectable · injection	HIKMA FARMACEUTICA	Prescription	23 Dec 2009
GRANISETRON HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML); EQ 1MG BASE/ML (EQ 1MG BASE/ML)	injectable · injection	MYLAN ASI	Prescription	9 Apr 2010

29 more — full table

EMA European Union — centrally authorised medicines

Sancuso Grünenthal GmbH · Authorised · authorised 20 Apr 2012 · ATC A04AA02

Therapeutic indication (EMA)

Prevention of nausea and vomiting in patients receiving moderately or highly emetogenic chemotherapy, with or without cisplatin, for up to five consecutive days. Sancuso may be used in patients receiving their first chemotherapy regimen or in patients who have previously received chemotherapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-GRANISETRON	02308894	1 MG	TABLET · ORAL	APOTEX INC
GRANISETRON HYDROCHLORIDE INJECTION	02322765	1 MG / ML	LIQUID · INTRAVENOUS	OMEGA LABORATORIES LIMITED
NAT-GRANISETRON	02452359	1 MG	TABLET · ORAL	NATCO PHARMA (CANADA) INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	GRANISETRON HCL 1 MG TABLET	$1.30504	per EA	23 Sep 2026
US NADAC	SANCUSO 3.1 MG/24 HR PATCH	$685.85231	per EA	23 Sep 2026
NHS Drug Tariff	Granisetron 1mg tablets	£41.91	10 tablet	1 Oct 2026
NHS Drug Tariff	Granisetron 1mg/1ml solution for injection ampoules	£24.20	10 ampoule	1 Oct 2026
NHS Drug Tariff	Granisetron 3.1mg/24hours transdermal patches	£56.00	1 patch	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)

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 23 Feb 2026 SUSTOL — 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 30 Apr 2020 SANCUSO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for granisetron →

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.