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Molecule

Rotigotine

Nonergot Dopamine Agonist
Available on requestNeurology
Presentations
7
Brands
1
Manufacturers
1
Available from stock
0

Rotigotine is a nonergot dopamine agonist indicated for the treatment of parkinson's disease, among other approved uses. It is available as transdermal patches and kits. MedsAcross supplies Rotigotine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Nonergot Dopamine Agonist, Dopamine Agonists
ATC classification
N04BC09 Rotigotine · Dopamine agonist
US FDA first approval
9 May 2007
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Transdermal
Dosage forms
Transdermal patch, Kit
Identifiers
UNII 87T4T8BO2ERxCUI 616739CAS 99755-59-6DrugBank DB05271Q411985

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

NEUPRO is a dopamine agonist indicated for the treatment of: Parkinson's disease. Moderate-to-severe primary Restless Legs Syndrome Parkinson's Disease (PD) NEUPRO is indicated for the treatment of Parkinson's disease. Restless Legs Syndrome (RLS) NEUPRO is indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome.

Source: US FDA prescribing information

How it works

Rotigotine is a non-ergoline dopamine agonist. The precise mechanism of action of rotigotine as a treatment for Parkinson's disease is unknown, although it is thought to be related to its ability to stimulate dopamine receptors within the caudate-putamen in the brain. The precise mechanism of action of rotigotine as a treatment for Restless Legs Syndrome is unknown but is thought to be related to its ability to stimulate dopamine receptors.

Source: US FDA prescribing information

Dosing overview

Parkinson's disease: Initially, 2 mg/24 hours for early-stage disease or 4 mg/24 hours for advanced-stage disease. The dose may be increased as needed by 2 mg/24 hours at weekly intervals, up to 6 mg/24 hours for early- stage disease and up to 8 mg/24 hours for advanced-stage disease. Restless Legs Syndrome: Initially, 1 mg/24 hours, increased as needed by 1 mg/24 hours at weekly intervals, up to 3 mg/24 hours. Apply once a day to the skin, press firmly in place for 30 seconds. Do not place NEUPRO on oily, irritated, or damaged skin, or where it will be rubbed by tight clothing. Do not use the same site more than once every 14 days. The prescribed dose may be achieved using single or multiple patches. To discontinue treatment, reduce the dose gradually until complete withdrawal of NEUPRO.

Source: US FDA prescribing information

Contraindications

NEUPRO is contraindicated in patients who have demonstrated hypersensitivity to rotigotine or the components of the transdermal system. History of hypersensitivity to rotigotine or components of the transdermal patch.

Source: US FDA prescribing information

Warnings and precautions

Contains sodium metabisulfite that may cause allergic-type reactions in those with sulfite sensitivity. Falling asleep during activities of daily living, including the operation of motor vehicles, and somnolence may occur. Hallucinations/psychosis and dyskinesia may occur. Symptomatic postural hypotension and syncope may occur, especially during dose escalation. Consider dose reduction or stopping NEUPRO if patient develops compulsive behaviors. Elevation of blood pressure and heart rate may occur. Application site reactions can occur and may be severe. Hyperpyrexia and confusion may occur with sudden discontinuation or dose reduction.

Source: US FDA prescribing information

Side effects

The following serious adverse reactions are discussed below and elsewhere in the labeling: Sulfite Sensitivity Falling Asleep During Activities of Daily Living and Somnolence Hallucinations/Psychosis Symptomatic Hypotension Syncope Impulse Control/Compulsive Behaviors Elevation of Blood Pressure and Heart Rate Weight Gain and Fluid Retention Dyskinesia Application Site Reactions Augmentation and Rebound in RLS Hyperpyrexia and Confusion Withdrawal Symptoms Fibrotic Complications Parkinson's disease: Most common adverse reactions (at least 5% greater than placebo) were nausea, vomiting, somnolence, application site reactions, dizziness, anorexia, disturbances in initiating and maintaining sleep, hyperhidrosis, visual disturbance, peripheral edema, and dyskinesia.

Source: US FDA prescribing information

Interactions

Dopamine Antagonists Dopamine antagonists, such as antipsychotics or metoclopramide, may diminish the effectiveness of NEUPRO.

Source: US FDA prescribing information

Storage

Store at 20° - 25°C (68° - 77°F), excursions permitted between 15° - 30°C (59° - 86°F). NEUPRO should be stored in the original pouch. Do not store outside of pouch.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

7 presentations of Rotigotine, sorted by availability.

MedicineManufacturerRegisterAvailability
Neupro 1 mg/24 hours transdermal patchTransdermalUCBUS FDAAvailable on request
Neupro 2 mg/24 hours transdermal patchTransdermalUCBUS FDAAvailable on request
Neupro 3 mg/24 hours transdermal patchTransdermalUCBUS FDAAvailable on request
Neupro 4 mg/24 hours transdermal patchTransdermalUCBUS FDAAvailable on request
Neupro 6 mg/24 hours transdermal patchTransdermalUCBUS FDAAvailable on request
Neupro 8 mg/24 hours transdermal patchTransdermalUCBUS FDAAvailable on request
Neupro kitUCBUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 9 May 2007Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Rotigotine in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Rotigotine available for export from India?

Yes, on request. MedsAcross lists 7 presentations of Rotigotine and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Rotigotine have?

The catalogue lists 1 brand names for Rotigotine, including Neupro.

Is Rotigotine approved by the US FDA?

Yes. The US FDA first approved Rotigotine on 9 May 2007, according to Drugs@FDA.

Is Rotigotine authorised in the European Union?

Yes. Rotigotine has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Rotigotine need cold chain shipping?

No listed presentation of Rotigotine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Rotigotine in?

Rotigotine is classified under ATC code N04BC09 (Rotigotine).

References

  1. Neupro prescribing information (UCB). U.S. National Library of Medicine, DailyMed. Retrieved 10 September 2026
  2. Neupro: European public assessment report (EPAR). European Medicines Agency. Retrieved 7 April 2026

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