Is Naloxone registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Naloxone, including NAXONE 0.02MG-ML INJ 2ML (0.02 mg/ml, Solution for injection/infusion, SAR 80.35); NAXONE 0.4MG-ML INJ (0.4 mg/ml, Solution for injection/infusion, SAR 93.25).

Is Naloxone approved by the US FDA?

Drugs@FDA lists 91 application product lines for Naloxone, including NALOXONE (Prescription); NALOXONE HYDROCHLORIDE (Prescription); NALOXONE HYDROCHLORIDE (Prescription); NALOXONE HYDROCHLORIDE (Prescription); NALOXONE HYDROCHLORIDE (Prescription).

Is Naloxone authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Naloxone: Nyxoid.

Is Naloxone on the WHO Model List of Essential Medicines?

Yes — 4.2. Antidotes and other substances used in poisonings > Specific (core list): Unintentional exposure to or harmful effects of opioids or related analgesics.

Are there safety signals or safety updates for Naloxone?

US FDA: 8 entries (latest 2025-12-22).

Active substance

Naloxone

SFDA 3
US FDA 91
EMA 1
Health Canada 12
US price lines 9
NHS prices 3
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
NAXONE 0.02MG-ML INJ 2ML	0.02 mg/ml	Solution for injection/infusion · Intravenous use	6 Ampoule	SAR 80.35	Generic · Prescription	Hikma Pharmaceuticals PLC	Valid
NAXONE 0.4MG-ML INJ	0.4 mg/ml	Solution for injection/infusion · Intravenous use	6 Ampoule	SAR 93.25	Generic · Prescription	Hikma Pharmaceuticals PLC	Valid
NALOXONE HCL 400MCG-ML AMP	400 µ/ml	Solution · Intravenous use	5 Ampoule	SAR 75.25	NCE · Prescription	HOSPIRA AUSTRALIA	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ANESTHESIA; DIABETIC NEUROPATHY; LOW BACK PAIN; NEUROPATHIC PAIN; PAIN MANAGEMENT IN CANCER PATIENTS; POST-HERPETIC NEURALGIA; POSTOPERATIVE PAIN

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

Product	Strength	Form · route	Applicant	Status	First approved
NALOXONE	0.4MG/ML	injectable · injection	HIKMA PHARMS	Prescription	22 Oct 1985
NALOXONE HYDROCHLORIDE	0.4MG/ML	injectable · injection	HOSPIRA	Prescription	18 Apr 1986
NALOXONE HYDROCHLORIDE	0.4MG/ML	injectable · injection	HOSPIRA	Prescription	7 Jan 1987
NALOXONE HYDROCHLORIDE	0.4MG/ML	injectable · injection	HOSPIRA	Prescription	7 Jan 1987
NALOXONE HYDROCHLORIDE	1MG/ML	injectable · injection	INTL MEDICATION	Prescription	24 Mar 1988
NALOXONE HYDROCHLORIDE	0.4MG/ML	injectable · injection	MYLAN INSTITUTIONAL	Prescription	6 Mar 2014
NARCAN	4MG/SPRAY	spray, metered · nasal	EMERGENT	Over-the-counter	18 Nov 2015
NALOXONE HYDROCHLORIDE	0.4MG/ML	injectable · injection	MYLAN INSTITUTIONAL	Prescription	29 Jun 2016
NALOXONE HYDROCHLORIDE	0.4MG/ML	injectable · injection	RISING	Prescription	28 Feb 2017
NALOXONE HYDROCHLORIDE	0.4MG/ML	injectable · injection	RISING	Prescription	14 Mar 2017
NALOXONE HYDROCHLORIDE	0.4MG/ML	injectable · injection	SOMERSET THERAPS LLC	Prescription	26 Jul 2017
NALOXONE HYDROCHLORIDE	0.4MG/ML	injectable · injection	SOMERSET THERAPS LLC	Prescription	8 Aug 2017
NALOXONE HYDROCHLORIDE	4MG/SPRAY	spray, metered · nasal	TEVA PHARMS USA	Over-the-counter	19 Apr 2019
NALOXONE HYDROCHLORIDE	0.4MG/ML	injectable · injection	EUGIA PHARMA	Prescription	4 Nov 2019
NALOXONE HYDROCHLORIDE	1MG/ML	injectable · injection	DR REDDYS	Prescription	16 Mar 2020
NALOXONE HYDROCHLORIDE	1MG/ML	injectable · injection	EUGIA PHARMA	Prescription	14 Jan 2021
NALOXONE HYDROCHLORIDE	0.4MG/ML; 1MG/ML	injectable · injection	BAXTER HLTHCARE CORP	Prescription	29 Jan 2021
KLOXXADO	8MG/SPRAY; 4MG/SPRAY	spray · nasal	HIKMA PHARMS	Prescription	29 Apr 2021
ZIMHI	5MG/0.5ML (5MG/0.5ML)	solution · intramuscular, subcutaneous	ZMI PHARMA	Prescription	15 Oct 2021
NALOXONE HYDROCHLORIDE	1MG/ML	injectable · injection	MYLAN LABS LTD	Prescription	9 Jun 2022
NALOXONE HYDROCHLORIDE	1MG/ML; 0.4MG/ML	injectable · injection	HIKMA PHARMS	Prescription	10 Jun 2022
NALOXONE HYDROCHLORIDE	4MG/SPRAY	spray, metered · nasal	PADAGIS ISRAEL	Over-the-counter	21 Jun 2022
NALOXONE HYDROCHLORIDE	1MG/ML	injectable · injection	PH HEALTH	Prescription	29 Jul 2022
NALOXONE HYDROCHLORIDE	0.4MG/ML; 1MG/ML	injectable · injection	ACCORD HLTHCARE	Prescription	26 Oct 2022
NALOXONE HYDROCHLORIDE	0.4MG/ML	injectable · injection	BAXTER HLTHCARE CORP	Prescription	7 Nov 2022

66 more — full table

EMA European Union — centrally authorised medicines

Nyxoid Mundipharma Corporation (Ireland) Limited · Authorised · authorised 9 Nov 2017 · ATC V03AB15

Therapeutic indication (EMA)

Nyxoid is intended for immediate administration as emergency therapy for known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression in both non-medical and healthcare settings. Nyxoid is indicated in adults and adolescents aged 14 years and over. Nyxoid is not a substitute for emergency medical care.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
INJECTABLE NALOXONE HYDROCHLORIDE	02455935	0.4 MG / ML	SOLUTION · INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS	OMEGA LABORATORIES LIMITED
NALOXONE HCL INJECTION - 0.4MG/ML USP	02148706	0.4 MG / ML	LIQUID · INTRAVENOUS; SUBCUTANEOUS; INTRAMUSCULAR	SANDOZ CANADA INCORPORATED
NALOXONE HCL INJECTION - 1MG/ML USP	02148714	1 MG / ML	LIQUID · INTRAVENOUS; SUBCUTANEOUS; INTRAMUSCULAR	SANDOZ CANADA INCORPORATED
NALOXONE HYDROCHLORIDE INJECTION	02393034	0.4 MG / ML	SOLUTION · INTRAVENOUS; INTRAMUSCULAR; SUBCUTANEOUS	OMEGA LABORATORIES LIMITED
NALOXONE HYDROCHLORIDE INJECTION	02393042	1 MG / ML	SOLUTION · INTRAVENOUS; INTRAMUSCULAR; SUBCUTANEOUS	OMEGA LABORATORIES LIMITED
NALOXONE HYDROCHLORIDE INJECTION USP	02382482	0.4 MG / ML	SOLUTION · SUBCUTANEOUS; INTRAVENOUS; INTRAMUSCULAR	HIKMA CANADA LIMITED
NALOXONE HYDROCHLORIDE INJECTION USP	02548194	0.4 MG / ML	SOLUTION · SUBCUTANEOUS; INTRAMUSCULAR	STERINOVA INC.
NALOXONE HYDROCHLORIDE INJECTION, USP	02534975	4 MG / 10 ML	SOLUTION · SUBCUTANEOUS; INTRAMUSCULAR; INTRAVENOUS	EUGIA PHARMA INC.
NALOXONE INJECTABLE	02458578	0.4 MG / ML	SOLUTION · SUBCUTANEOUS; INTRAMUSCULAR; INTRAVENOUS	HIKMA CANADA LIMITED
NARCAN NASAL SPRAY	02458187	4 MG / 0.1 ML	SPRAY (METERED-DOSE) · NASAL	EMERGENT OPERATIONS IRELAND LIMITED
S.O.S. NALOXONE HYDROCHLORIDE INJECTION	02453258	0.4 MG / ML	SOLUTION · SUBCUTANEOUS; INTRAMUSCULAR; INTRAVENOUS	SANDOZ CANADA INCORPORATED
TEVA-NALOXONE NASAL SPRAY	02511568	4 MG / 0.1 ML	SPRAY (METERED-DOSE) · NASAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	FT NALOXONE HCL 4 MG NASAL SPR	$17.17734	per EA	23 Sep 2026
US NADAC	GNP NALOXONE HCL 4 MG NASAL SP	$17.17734	per EA	23 Sep 2026
US NADAC	KLOXXADO 8 MG NASAL SPRAY	$59.77417	per EA	23 Sep 2026
US NADAC	NALOXONE 0.4 MG/ML VIAL	$3.82425	per ML	23 Sep 2026
US NADAC	NALOXONE 2 MG/2 ML SYRINGE	$6.27129	per ML	23 Sep 2026
US NADAC	NALOXONE 2 MG/2 ML SYRINGE	$12.74097	per ML	23 Sep 2026
US NADAC	NALOXONE 4 MG/10 ML VIAL	$3.82425	per ML	23 Sep 2026
US NADAC	NALOXONE HCL 4 MG NASAL SPRAY	$17.17734	per EA	23 Sep 2026
US NADAC	NARCAN 4 MG NASAL SPRAY	$16.449	per EA	23 Sep 2026
NHS Drug Tariff	Naloxone 1.26mg/0.1ml nasal spray unit dose	£25.00	2 unit dose	1 Oct 2026
NHS Drug Tariff	Naloxone 1.8mg/0.1ml nasal spray unit dose	£27.50	2 unit dose	1 Oct 2026
NHS Drug Tariff	Naloxone 2mg/2ml solution for injection pre-filled syringes	£18.00	1 pre-filled disposable injection	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)

4.2. Antidotes and other substances used in poisonings > Specific · core
Unintentional exposure to or harmful effects of opioids or related analgesics
Parenteral > General injections > unspecified: 400 µg per 1 mL in ampoule (naloxone hydrochloride)

Safety signals and safety-related labeling changes

US FDA 22 Dec 2025 SUBOXONE — 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 Dec 2025 ZUBSOLV — 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 25 Aug 2025 KLOXXADO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 15 Dec 2023 CASSIPA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 17 Jun 2022 BUNAVAIL — 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 17 Jun 2022 SUBOXONE — 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
US FDA 18 Sep 2018 TARGINIQ — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 24 Jan 2017 NARCAN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for naloxone →

Combinations containing Naloxone

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.