Is Ropinirole registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Ropinirole.

Is Ropinirole approved by the US FDA?

Drugs@FDA lists 23 application product lines for Ropinirole, including ROPINIROLE HYDROCHLORIDE (Prescription); ROPINIROLE HYDROCHLORIDE (Prescription); ROPINIROLE HYDROCHLORIDE (Prescription); ROPINIROLE HYDROCHLORIDE (Prescription); ROPINIROLE HYDROCHLORIDE (Prescription).

Are there safety signals or safety updates for Ropinirole?

US FDA: 2 entries (latest 2021-07-12).

Active substance

Ropinirole

SFDA 7
US FDA 23
Health Canada 8
US price lines 12
NHS prices 10
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
REQUIP 1MG TAB	1 mg	Tablet · Oral use	21 Blister	SAR 60.45	NCE · Prescription	SMIITHKLINE BEECHAM	Withdrawn by MAH · Not Marketed
REQUIP 2MG TAB	2 mg	Tablet · Oral use	21 Blister	SAR 91.70	NCE · Prescription	SMIITHKLINE BEECHAM	Withdrawn by MAH · Not Marketed
REQUIP 5MG TAB	5 mg	Tablet · Oral use	84 Blister	SAR 574.65	NCE · Prescription	SMIITHKLINE BEECHAM	Withdrawn by MAH · Not Marketed
REQUIP PD 24HOUR 2 mg prolonged release tablet	2 mg	Prolonged-release tablet · Oral use	28 Blister	SAR 32.75	NCE · Prescription	GLAXOWELLCOME	Withdrawn by MAH · Not Marketed
REQUIP PD 24HOUR 4 mg prolonged release tablet	4 mg	Prolonged-release tablet · Oral use	28 Blister	SAR 68.70	NCE · Prescription	SMIITHKLINE BEECHAM	Withdrawn by MAH · Not Marketed
REQUIP PD 24HOUR 8 mg prolonged release tablet	8 mg	Prolonged-release tablet · Oral use	28 Blister	SAR 109.60	NCE · Prescription	SMIITHKLINE BEECHAM	Withdrawn by MAH · Not Marketed
REQUIP0.25MG TAB	0.25 mg	Tablet · Oral use	84 Blister	SAR 66.75	NCE · Prescription	SMIITHKLINE BEECHAM	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE; EQ 0.5MG BASE; EQ 1MG BASE; EQ 2MG BASE; EQ 3MG BASE; EQ 4MG BASE; EQ 5MG BASE	tablet · oral	PRINSTON INC	Prescription	5 May 2008
ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE; EQ 0.5MG BASE; EQ 1MG BASE; EQ 2MG BASE; EQ 3MG BASE; EQ 4MG BASE; EQ 5MG BASE	tablet · oral	CHARTWELL RX	Prescription	29 May 2008
ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE; EQ 0.5MG BASE; EQ 1MG BASE; EQ 2MG BASE; EQ 3MG BASE; EQ 4MG BASE; EQ 5MG BASE	tablet · oral	ZYDUS LIFESCIENCES	Prescription	1 Jun 2009
ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE; EQ 0.5MG BASE; EQ 1MG BASE; EQ 2MG BASE; EQ 3MG BASE; EQ 4MG BASE; EQ 5MG BASE	tablet · oral	GLENMARK PHARMS LTD	Prescription	25 Feb 2010
ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE; EQ 0.5MG BASE; EQ 1MG BASE; EQ 2MG BASE; EQ 3MG BASE; EQ 4MG BASE; EQ 5MG BASE	tablet · oral	ALEMBIC LTD	Prescription	24 Mar 2010
ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE; EQ 0.5MG BASE; EQ 1MG BASE; EQ 2MG BASE; EQ 3MG BASE; EQ 4MG BASE; EQ 5MG BASE	tablet · oral	MLV	Prescription	7 Feb 2012
ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE; EQ 4MG BASE; EQ 6MG BASE; EQ 8MG BASE; EQ 12MG BASE	tablet, extended release · oral	ACTAVIS ELIZABETH	Prescription	17 May 2012
ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE; EQ 4MG BASE; EQ 6MG BASE; EQ 8MG BASE; EQ 12MG BASE	tablet, extended release · oral	SANDOZ INC	Prescription	6 Jun 2012
ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE; EQ 4MG BASE; EQ 6MG BASE; EQ 8MG BASE; EQ 12MG BASE	tablet, extended release · oral	DR REDDYS LABS LTD	Prescription	6 Jun 2012
ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE; EQ 4MG BASE; EQ 6MG BASE; EQ 8MG BASE; EQ 12MG BASE	tablet, extended release · oral	CHARTWELL RX	Prescription	27 Aug 2012
ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE; EQ 0.5MG BASE; EQ 1MG BASE; EQ 2MG BASE; EQ 3MG BASE; EQ 4MG BASE; EQ 5MG BASE	tablet · oral	ORBION PHARMS	Prescription	28 Nov 2012
ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE; EQ 4MG BASE; EQ 6MG BASE; EQ 8MG BASE; EQ 12MG BASE	tablet, extended release · oral	ALEMBIC	Prescription	22 Apr 2013
ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE; EQ 0.5MG BASE; EQ 1MG BASE; EQ 2MG BASE; EQ 3MG BASE; EQ 4MG BASE; EQ 5MG BASE	tablet · oral	ACCORD HLTHCARE	Prescription	28 Feb 2017
ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE; EQ 4MG BASE; EQ 6MG BASE; EQ 8MG BASE; EQ 12MG BASE	tablet, extended release · oral	PRINSTON INC	Prescription	11 May 2022
ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE; EQ 4MG BASE; EQ 6MG BASE; EQ 8MG BASE; EQ 12MG BASE	tablet, extended release · oral	ELITE LABS INC	Prescription	10 Nov 2025
REQUIP	EQ 0.25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	GLAXOSMITHKLINE LLC	Discontinued	19 Sep 1997
ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE; EQ 0.5MG BASE; EQ 1MG BASE; EQ 2MG BASE; EQ 3MG BASE; EQ 4MG BASE; EQ 5MG BASE	tablet · oral	COSETTE PHARMS NC	Discontinued	5 May 2008
ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE; EQ 0.5MG BASE; EQ 1MG BASE; EQ 2MG BASE; EQ 3MG BASE; EQ 4MG BASE; EQ 5MG BASE	tablet · oral	HIKMA PHARMS	Discontinued	5 May 2008
ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE; EQ 0.5MG BASE; EQ 1MG BASE; EQ 2MG BASE; EQ 3MG BASE; EQ 4MG BASE; EQ 5MG BASE	tablet · oral	PHARMOBEDIENT	Discontinued	5 May 2008
ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE; EQ 0.5MG BASE; EQ 1MG BASE; EQ 2MG BASE; EQ 3MG BASE; EQ 4MG BASE; EQ 5MG BASE	tablet · oral	EPIC PHARMA LLC	Discontinued	20 May 2008
REQUIP XL	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 12MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet, extended release · oral	GLAXOSMITHKLINE LLC	Discontinued	13 Jun 2008
ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE; EQ 4MG BASE; EQ 6MG BASE; EQ 8MG BASE; EQ 12MG BASE	tablet, extended release · oral	WATSON LABS INC	Discontinued	6 Jun 2012
ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE; EQ 3MG BASE; EQ 4MG BASE; EQ 6MG BASE; EQ 8MG BASE; EQ 12MG BASE	tablet, extended release · oral	AUROBINDO PHARMA USA	Discontinued	15 Oct 2012

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
SPC-ROPINIROLE	02314037	0.25 MG	TABLET · ORAL	SUN PHARMA CANADA INC
SPC-ROPINIROLE	02314053	1 MG	TABLET · ORAL	SUN PHARMA CANADA INC
SPC-ROPINIROLE	02314061	2 MG	TABLET · ORAL	SUN PHARMA CANADA INC
SPC-ROPINIROLE	02314088	5 MG	TABLET · ORAL	SUN PHARMA CANADA INC
TEVA-ROPINIROLE	02316846	0.25 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-ROPINIROLE	02316854	1 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-ROPINIROLE	02316862	2 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-ROPINIROLE	02316870	5 MG	TABLET · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ROPINIROLE HCL 0.25 MG TABLET	$0.04599	per EA	23 Sep 2026
US NADAC	ROPINIROLE HCL 0.5 MG TABLET	$0.04297	per EA	23 Sep 2026
US NADAC	ROPINIROLE HCL 1 MG TABLET	$0.04774	per EA	23 Sep 2026
US NADAC	ROPINIROLE HCL 2 MG TABLET	$0.0672	per EA	23 Sep 2026
US NADAC	ROPINIROLE HCL 3 MG TABLET	$0.0768	per EA	23 Sep 2026
US NADAC	ROPINIROLE HCL 4 MG TABLET	$0.08139	per EA	23 Sep 2026
US NADAC	ROPINIROLE HCL 5 MG TABLET	$0.08434	per EA	23 Sep 2026
US NADAC	ROPINIROLE HCL ER 12 MG TABLET	$1.81115	per EA	23 Sep 2026
US NADAC	ROPINIROLE HCL ER 2 MG TABLET	$0.3487	per EA	23 Sep 2026
US NADAC	ROPINIROLE HCL ER 4 MG TABLET	$0.4617	per EA	23 Sep 2026
US NADAC	ROPINIROLE HCL ER 6 MG TABLET	$1.34089	per EA	23 Sep 2026
US NADAC	ROPINIROLE HCL ER 8 MG TABLET	$0.9066	per EA	7 Oct 2026
NHS Drug Tariff	Ropinirole 1mg tablets	£15.06	84 tablet	1 Oct 2026
NHS Drug Tariff	Ropinirole 250microgram tablets	£4.35	12 tablet	1 Oct 2026
NHS Drug Tariff	Ropinirole 2mg modified-release tablets	£12.54	28 tablet	1 Oct 2026
NHS Drug Tariff	Ropinirole 2mg tablets	£10.64	28 tablet	1 Oct 2026
NHS Drug Tariff	Ropinirole 3mg modified-release tablets	£8.46	28 tablet	1 Oct 2026
NHS Drug Tariff	Ropinirole 4mg modified-release tablets	£25.09	28 tablet	1 Oct 2026
NHS Drug Tariff	Ropinirole 500microgram tablets	£3.53	28 tablet	1 Oct 2026
NHS Drug Tariff	Ropinirole 5mg tablets	£195.92	84 tablet	1 Oct 2026
NHS Drug Tariff	Ropinirole 6mg modified-release tablets	£15.32	28 tablet	1 Oct 2026
NHS Drug Tariff	Ropinirole 8mg modified-release tablets	£42.11	28 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 12 Jul 2021 REQUIP — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 12 Jul 2021 REQUIP XL — 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

All safety entries for ropinirole →

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.