Is Vigabatrin 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 Vigabatrin, including SABRIL 500MG F.C.TAB (500 mg, Film-coated tablet, SAR 213.70).

Is Vigabatrin approved by the US FDA?

Drugs@FDA lists 30 application product lines for Vigabatrin, including SABRIL (Prescription); SABRIL (Prescription); VIGABATRIN (Prescription); VIGABATRIN (Prescription); VIGADRONE (Prescription).

Is Vigabatrin authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Vigabatrin: Kigabeq.

Are there safety signals or safety updates for Vigabatrin?

US FDA: 3 entries (latest 2025-09-03).

Active substance

Vigabatrin

SFDA 2
US FDA 30
EMA 1
Health Canada 2
NHS prices 4
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
SABRIL 500MG F.C.TAB	500 mg	Film-coated tablet · Oral use	100 Tablet Container	SAR 213.70	NCE · Prescription	SANOFI WINTHROP INDUSTRIE	Valid
SABRIL 500MG F.C.TAB	500 mg	Film-coated tablet · Oral use	100 Tablet Container	SAR 213.70	NCE · Prescription	sanofi-aventis	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

FOCAL SEIZURES

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

Product	Strength	Form · route	Applicant	Status	First approved
SABRIL	500MG	tablet · oral	LUNDBECK PHARMS LLC	Prescription	21 Aug 2009
SABRIL	500MG/PACKET	for solution · oral	LUNDBECK PHARMS LLC	Prescription	21 Aug 2009
VIGABATRIN	500MG/PACKET	for solution · oral	PH HEALTH	Prescription	27 Apr 2017
VIGABATRIN	500MG/PACKET	for solution · oral	AMNEAL PHARMS	Prescription	13 Mar 2018
VIGADRONE	500MG/PACKET	for solution · oral	BORA	Prescription	21 Jun 2018
VIGABATRIN	500MG/PACKET	for solution · oral	DR REDDYS	Prescription	20 Nov 2018
VIGABATRIN	500MG	tablet · oral	TEVA PHARMS USA	Prescription	14 Jan 2019
VIGABATRIN	500MG/PACKET	for solution · oral	INVAGEN PHARMS	Prescription	3 Dec 2019
VIGABATRIN	500MG/PACKET	for solution · oral	ALKEM LABS LTD	Prescription	2 Dec 2020
VIGABATRIN	500MG/PACKET	for solution · oral	ANNORA PHARMA	Prescription	26 Jan 2021
VIGABATRIN	500MG	tablet · oral	DR REDDYS	Prescription	29 Jan 2021
VIGABATRIN	500MG	tablet · oral	DEXCEL	Prescription	23 Sep 2021
VIGABATRIN	500MG/PACKET	for solution · oral	AUROBINDO PHARMA LTD	Prescription	29 Sep 2021
VIGABATRIN	500MG	tablet · oral	ZYDUS LIFESCIENCES	Prescription	19 Jan 2022
VIGABATRIN	500MG	tablet · oral	AUROBINDO PHARMA LTD	Prescription	10 May 2022
VIGPODER	500MG/PACKET	for solution · oral	PYROS PHARMS	Prescription	24 Jun 2022
VIGABATRIN	500MG	tablet · oral	HIKMA PHARMS	Prescription	29 Aug 2022
VIGABATRIN	500MG/PACKET	for solution · oral	MSN	Prescription	7 Sep 2022
VIGABATRIN	500MG	tablet · oral	CARNEGIE	Prescription	28 Apr 2023
VIGABATRIN	500MG	tablet · oral	UPSHER SMITH LABS	Prescription	29 Jun 2023
VIGAFYDE	100MG/ML	solution · oral	PYROS PHARMS	Prescription	17 Jun 2024
VIGABATRIN	500MG/PACKET	for solution · oral	TEVA PHARMS USA	Discontinued	23 Apr 2018
VIGABATRIN	500MG/PACKET	for solution · oral	GRANULES	Discontinued	24 Apr 2020
VIGABATRIN	500MG/PACKET	for solution · oral	ACCORD HLTHCARE	Discontinued	13 Nov 2020
VIGABATRIN	500MG/PACKET	for solution · oral	ADAPTIS	Discontinued	13 May 2021

5 more — full table

EMA European Union — centrally authorised medicines

Kigabeq Orphelia Pharma S.A.S. · Authorised · authorised 20 Sep 2018 · ATC N03AG04

Therapeutic indication (EMA)

Kigabeq is indicated in infants and children from 1 month to less than 7 years of age for: Treatment in monotherapy of infantile spasms (West's syndrome). Treatment in combination with other antiepileptic medicinal products for patients with resistant partial epilepsy (focal onset seizures) with or without secondary generalisation, that is where all other appropriate medicinal product combinations have proved inadequate or have not been tolerated.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
SABRIL	02065819	500 MG	TABLET · ORAL	LUNDBECK PHARMACEUTICALS LLC
SABRIL	02068036	500 MG / SACHET	POWDER FOR SOLUTION · ORAL	LUNDBECK PHARMACEUTICALS LLC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
NHS Drug Tariff	Vigabatrin 100mg soluble tablets sugar free	£66.47	100 tablet	1 Oct 2026
NHS Drug Tariff	Vigabatrin 500mg granules for oral solution sachets sugar free	£24.60	50 sachet	1 Oct 2026
NHS Drug Tariff	Vigabatrin 500mg soluble tablets sugar free	£148.72	50 tablet	1 Oct 2026
NHS Drug Tariff	Vigabatrin 500mg tablets	£44.41	100 tablet	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 3 Sep 2025 VIGAFYDE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 24 Jan 2020 SABRIL — 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
US FDA 24 Jan 2020 SABRIL — 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

All safety entries for vigabatrin →

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.