Is Rotigotine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 4 valid registrations of Rotigotine, including NEUPRO 2 mg/24 hrs Transdermal Patches (2 mg, Transdermal patch, SAR 132.90); NEUPRO 4 MG/24 HRS TRANSDERMAL PATCHES (4 mg, Transdermal patch, SAR 219.00); NEUPRO 6 mg/24 hrs Transdermal Patches (6 mg, Transdermal patch, SAR 296.00); NEUPRO 8 mg/24 hrs Transdermal Patches (8 mg, Transdermal patch, SAR 364.00).

Is Rotigotine approved by the US FDA?

Drugs@FDA lists 1 application product line for Rotigotine, including NEUPRO (Prescription).

Is Rotigotine authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Rotigotine: Neupro.

Are there safety signals or safety updates for Rotigotine?

US FDA: 1 entry (latest 2021-07-12).

Active substance

Rotigotine

SFDA 4
US FDA 1
EMA 3
Health Canada 6
US price lines 6
NHS prices 6
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
NEUPRO 2 mg/24 hrs Transdermal Patches	2 mg	Transdermal patch · Transdermal use	28 Patch	SAR 132.90	NCE · Prescription	UCB Pharma S.A	Valid
NEUPRO 4 MG/24 HRS TRANSDERMAL PATCHES	4 mg	Transdermal patch · Transdermal use	28 Patch	SAR 219.00	NCE · Prescription	UCB Pharma S.A.	Valid
NEUPRO 6 mg/24 hrs Transdermal Patches	6 mg	Transdermal patch · Transdermal use	28 Patch	SAR 296.00	NCE · Prescription	UCB Pharma S.A.	Valid
NEUPRO 8 mg/24 hrs Transdermal Patches	8 mg	Transdermal patch · Transdermal use	28 Patch	SAR 364.00	NCE · Prescription	UCB Pharma S.A.	Valid

Indications — CHI Daman Drug Formulary

PARKINSONISM

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

Product	Strength	Form · route	Applicant	Status	First approved
NEUPRO	2MG/24HR; 4MG/24HR; 6MG/24HR; 1MG/24HR; 3MG/24HR; 8MG/24HR	film, extended release · transdermal	UCB INC	Prescription	9 May 2007

EMA European Union — centrally authorised medicines

Neupro UCB Pharma S.A. · Authorised · authorised 15 Feb 2006 · ATC N04BC09

Therapeutic indication (EMA)

Parkinson's disease: Neupro is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or 'on-off' fluctuations). Restless-legs syndrome: Neupro is indicated for the symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in adults.

Rotigotine Mylan Mylan S.A.S · Application withdrawn · ATC N04BC09

Therapeutic indication (EMA)

Treatment of idiopathic Restless Legs Syndrome and Parkinson's disease.

Leganto UCB Pharma S.A. · Withdrawn · authorised 16 Jun 2011 · ATC N04BC09

Therapeutic indication (EMA)

Leganto is indicated for the symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in adults. Leganto is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson’s disease as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or ‘on-off’ fluctuations).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
NEUPRO	02403897	1 MG / 24 HOUR	PATCH · TRANSDERMAL	UCB CANADA INC
NEUPRO	02403900	2 MG / 24 HOUR	PATCH · TRANSDERMAL	UCB CANADA INC
NEUPRO	02403919	3 MG / 24 HOUR	PATCH · TRANSDERMAL	UCB CANADA INC
NEUPRO	02403927	4 MG / 24 HOUR	PATCH · TRANSDERMAL	UCB CANADA INC
NEUPRO	02403935	6 MG / 24 HOUR	PATCH · TRANSDERMAL	UCB CANADA INC
NEUPRO	02403943	8 MG / 24 HOUR	PATCH · TRANSDERMAL	UCB CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	NEUPRO 1 MG/24 HR PATCH	$28.28679	per EA	23 Sep 2026
US NADAC	NEUPRO 2 MG/24 HR PATCH	$28.26022	per EA	23 Sep 2026
US NADAC	NEUPRO 3 MG/24 HR PATCH	$28.25044	per EA	23 Sep 2026
US NADAC	NEUPRO 4 MG/24 HR PATCH	$28.31614	per EA	23 Sep 2026
US NADAC	NEUPRO 6 MG/24 HR PATCH	$28.17877	per EA	23 Sep 2026
US NADAC	NEUPRO 8 MG/24 HR PATCH	$28.24156	per EA	23 Sep 2026
NHS Drug Tariff	Rotigotine 1mg/24hours transdermal patches	£77.24	28 patch	1 Oct 2026
NHS Drug Tariff	Rotigotine 2mg/24hours transdermal patches	£81.10	28 patch	1 Oct 2026
NHS Drug Tariff	Rotigotine 3mg/24hours transdermal patches	£102.35	28 patch	1 Oct 2026
NHS Drug Tariff	Rotigotine 4mg/24hours transdermal patches	£123.60	28 patch	1 Oct 2026
NHS Drug Tariff	Rotigotine 6mg/24hours transdermal patches	£149.93	28 patch	1 Oct 2026
NHS Drug Tariff	Rotigotine 8mg/24hours transdermal patches	£149.93	28 patch	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 NEUPRO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for rotigotine →

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.