Is Amisulpride registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 14 valid registrations of Amisulpride, including Amilian (400 mg, Tablet, SAR 178.45); Amilian (200 mg, Tablet, SAR 114.30); Amilian (100 mg, Tablet, SAR 60.90); SILOMES 100 mg Tablet (100 mg, Tablet, SAR 60.90); SILOMES 200 mg Tablet (200 mg, Tablet, SAR 114.30).

Is Amisulpride approved by the US FDA?

Drugs@FDA lists 1 application product line for Amisulpride, including BARHEMSYS (Prescription).

Active substance

Amisulpride

SFDA 18
US FDA 1
NHS prices 5

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Amilian	400 mg	Tablet · Oral use	30 Blister	SAR 178.45	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
Amilian	200 mg	Tablet · Oral use	30 Blister	SAR 114.30	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
Amilian	100 mg	Tablet · Oral use	30 Blister	SAR 60.90	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
SILOMES 100 mg Tablet	100 mg	Tablet · Oral use	30 Blister	SAR 60.90	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
SILOMES 200 mg Tablet	200 mg	Tablet · Oral use	30 Blister	SAR 114.30	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
SILOMES 400 mg Tablet	400 mg	Tablet · Oral use	30 Blister	SAR 178.45	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
SILOMES 50MG TABLET	50 mg	Tablet · Oral use	30 Blister	SAR 40.55	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
SOLIAN 100 MG TABLET	100 mg	Tablet · Oral use	30 Blister	SAR 71.20	Generic · Prescription	sanofi-aventis	Valid
SOLIAN 200MG TAB	200 mg	Tablet · Oral use	30 Blister	SAR 140.65	NCE · Prescription	sanofi-aventis	Valid
SOLIAN 400 MG FILM COATED TABLETS	400 mg	Film-coated tablet · Oral use	30 Blister	SAR 220.60	Generic · Prescription	sanofi-aventis	Valid
SOLIAN 50MG TAB	50 mg	Tablet · Oral use	30 Blister	SAR 49.90	NCE · Prescription	Sanofi Aventis France	Valid
Sulmetic	400 mg	Film-coated tablet · Oral use	30 Blister	SAR 147.20	Generic · Prescription	Aurobindo Pharma Limited	Valid
Sulmetic	200 mg	Film-coated tablet · Oral use	30 Blister	SAR 94.30	Generic · Prescription	Aurobindo Pharma Limited	Valid
Sulmetic	100 mg	Tablet · Oral use	30 Blister	SAR 54.80	Generic · Prescription	Aurobindo Pharma Limited	Valid
SOLIAN 100 MG TABLET	100 mg	Tablet · Oral use	30 Blister	SAR 93.70	Generic · Prescription	sanofi-aventis	Withdrawn by MAH · Not Marketed
SOLIAN 200MG TAB	200 mg	Tablet · Oral use	30 Blister	SAR 175.80	NCE · Prescription	sanofi-aventis	Withdrawn by MAH · Not Marketed
SOLIAN 400 MG FILM COATED TABLETS	400 mg	Film-coated tablet · Oral use	30 Blister	SAR 275.75	Generic · Prescription	sanofi-aventis	Withdrawn by MAH · Not Marketed
SOLIAN 50MG TAB	50 mg	Tablet · Oral use	30 Blister	SAR 62.35	NCE · Prescription	sanofi-aventis	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD); SCHIZOPHRENIA; TOURETTE SYNDROME

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

Product	Strength	Form · route	Applicant	Status	First approved
BARHEMSYS	5MG/2ML (2.5MG/ML); 10MG/4ML (2.5MG/ML)	solution · intravenous	LXO IRELAND	Prescription	26 Feb 2020

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
NHS Drug Tariff	Amisulpride 100mg tablets	£3.95	60 tablet	1 Oct 2026
NHS Drug Tariff	Amisulpride 100mg/ml oral solution sugar free	£79.88	60 ml	1 Oct 2026
NHS Drug Tariff	Amisulpride 200mg tablets	£7.54	60 tablet	1 Oct 2026
NHS Drug Tariff	Amisulpride 400mg tablets	£31.44	60 tablet	1 Oct 2026
NHS Drug Tariff	Amisulpride 50mg tablets	£2.91	60 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.

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.