Is Rufinamide 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 Rufinamide, including Rufzel (40 mg/ml, Oral suspension, SAR 665.50); Rufzel (400 mg, Tablet, SAR 1732.80); Rufzel (200 mg, Tablet, SAR 866.00).

Is Rufinamide approved by the US FDA?

Drugs@FDA lists 18 application product lines for Rufinamide, including BANZEL (Prescription); BANZEL (Prescription); RUFINAMIDE (Prescription); RUFINAMIDE (Prescription); RUFINAMIDE (Prescription).

Is Rufinamide authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Rufinamide: Inovelon.

Are there safety signals or safety updates for Rufinamide?

US FDA: 2 entries (latest 2019-11-29).

Active substance

Rufinamide

SFDA 3
US FDA 18
EMA 1
Health Canada 5
US price lines 6
NHS prices 4
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
Rufzel	40 mg/ml	Oral suspension · Oral use	1 Bottle	SAR 665.50	Generic · Prescription	Saudi Amarox	Valid
Rufzel	400 mg	Tablet · Oral use	120 Bottle	SAR 1732.80	Generic · Prescription	Saudi Amarox	Valid
Rufzel	200 mg	Tablet · Oral use	120 Bottle	SAR 866.00	Generic · Prescription	Saudi Amarox	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
BANZEL	200MG; 400MG	tablet · oral	EISAI INC	Prescription	14 Nov 2008
BANZEL	40MG/ML	suspension · oral	EISAI INC	Prescription	3 Mar 2011
RUFINAMIDE	200MG; 400MG	tablet · oral	HIKMA PHARMS	Prescription	16 May 2016
RUFINAMIDE	200MG; 400MG	tablet · oral	GLENMARK PHARMS LTD	Prescription	16 May 2016
RUFINAMIDE	200MG; 400MG	tablet · oral	SCIEGEN PHARMS	Prescription	16 May 2016
RUFINAMIDE	40MG/ML	suspension · oral	HIKMA PHARMS	Prescription	23 Apr 2019
RUFINAMIDE	40MG/ML	suspension · oral	BIONPHARMA	Prescription	23 Apr 2019
RUFINAMIDE	40MG/ML	suspension · oral	LUPIN	Prescription	18 Dec 2020
RUFINAMIDE	40MG/ML	suspension · oral	ALKEM LABS LTD	Prescription	23 Feb 2021
RUFINAMIDE	200MG; 400MG	tablet · oral	HETERO LABS LTD III	Prescription	11 May 2021
RUFINAMIDE	100MG; 200MG; 400MG	tablet · oral	LUPIN	Prescription	17 Aug 2022
RUFINAMIDE	40MG/ML	suspension · oral	AUROBINDO PHARMA	Prescription	26 Oct 2022
RUFINAMIDE	40MG/ML	suspension · oral	CHARTWELL RX	Prescription	7 Nov 2022
RUFINAMIDE	200MG; 400MG	tablet · oral	MICRO LABS	Prescription	15 May 2023
RUFINAMIDE	200MG; 400MG	tablet · oral	AUROBINDO PHARMA	Prescription	16 Jun 2023
RUFINAMIDE	40MG/ML	suspension · oral	HETERO LABS LTD III	Prescription	5 Dec 2023
RUFINAMIDE	40MG/ML	suspension · oral	MSN	Prescription	15 Apr 2025
BANZEL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	EISAI INC	Discontinued	14 Nov 2008

EMA European Union — centrally authorised medicines

Inovelon Eisai GmbH · Authorised · authorised 16 Jan 2007 · ATC N03AF03

Therapeutic indication (EMA)

Inovelon is indicated as adjunctive therapy in the treatment of seizures associated with Lennox Gastaut syndrome in patients 4 years of age and older.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AURO-RUFINAMIDE	02545985	200 MG	TABLET · ORAL	AURO PHARMA INC
AURO-RUFINAMIDE	02545993	400 MG	TABLET · ORAL	AURO PHARMA INC
BANZEL	02369613	100 MG	TABLET · ORAL	EISAI LIMITED
BANZEL	02369621	200 MG	TABLET · ORAL	EISAI LIMITED
BANZEL	02369648	400 MG	TABLET · ORAL	EISAI LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	BANZEL 200 MG TABLET	$12.61034	per EA	23 Sep 2026
US NADAC	BANZEL 40 MG/ML SUSPENSION	$3.64872	per ML	23 Sep 2026
US NADAC	BANZEL 400 MG TABLET	$25.18264	per EA	23 Sep 2026
US NADAC	RUFINAMIDE 200 MG TABLET	$0.881	per EA	23 Sep 2026
US NADAC	RUFINAMIDE 40 MG/ML SUSPENSION	$0.20341	per ML	23 Sep 2026
US NADAC	RUFINAMIDE 400 MG TABLET	$1.39131	per EA	23 Sep 2026
NHS Drug Tariff	Rufinamide 100mg tablets	£5.15	10 tablet	1 Oct 2026
NHS Drug Tariff	Rufinamide 200mg tablets	£61.77	60 tablet	1 Oct 2026
NHS Drug Tariff	Rufinamide 400mg tablets	£102.96	60 tablet	1 Oct 2026
NHS Drug Tariff	Rufinamide 40mg/ml oral suspension sugar free	£94.71	460 ml	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.

Safety signals and safety-related labeling changes

US FDA 29 Nov 2019 BANZEL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 28 Nov 2019 BANZEL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for rufinamide →

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.