Is Esketamine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Esketamine, including SPRAVATO (28 mg, Nasal spray, SAR 1905.75); Spravato (28 mg, Nasal spray, SAR 952.90).

Is Esketamine approved by the US FDA?

Drugs@FDA lists 1 application product line for Esketamine, including SPRAVATO (Prescription).

Is Esketamine authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Esketamine: Spravato.

Are there safety signals or safety updates for Esketamine?

EMA PRAC: 1 entry; US FDA: 1 entry (latest 2025-04-28).

Active substance

Esketamine

SFDA 3
US FDA 1
EMA 1
Health Canada 1
US price lines 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
SPRAVATO	28 mg	Nasal spray · Nasal use	2 Spray Container	SAR 1905.75	NCE · Prescription	JANSSEN PHARMACEUTICA N.V	Valid
SPRAVATO	28 mg	Nasal spray · Nasal use	3 Spray Container	SAR 2858.65	NCE · Prescription	JANSSEN PHARMACEUTICA N.V	Valid
Spravato	28 mg	Nasal spray · Nasal use	1 Spray Container	SAR 952.90	NCE · Prescription	JANSSEN PHARMACEUTICA N.V	Valid

Indications — CHI Daman Drug Formulary

DEPRESSION

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

Product	Strength	Form · route	Applicant	Status	First approved
SPRAVATO	EQ 28MG BASE	spray · nasal	JANSSEN PHARMS	Prescription	5 Mar 2019

EMA European Union — centrally authorised medicines

Spravato Janssen-Cilag International NV · Authorised · authorised 18 Dec 2019 · ATC N06AX27

Therapeutic indication (EMA)

Spravato, in combination with a SSRI or SNRI, is indicated for adults with treatment-resistant Major Depressive Disorder, who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
SPRAVATO	02499290	28 MG / 2 ACT	SOLUTION · NASAL	JANSSEN INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	SPRAVATO 56 MG DOSE PACK	$426.299	per EA	29 Jan 2026
US NADAC	SPRAVATO 84 MG DOSE PACK	$429.97909	per EA	23 Sep 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.

Safety signals and safety-related labeling changes

US FDA 28 Apr 2025 SPRAVATO — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 11 Jul 2024 PRAC signal: Bradycardia
Action for MAH: update of the product information: No

All safety entries for esketamine →

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.