Rotigotine
Neupro · ATC code N04BC09
Also known as: Rotigotin · Brand names: Neupro, Kinparlev, Rotigotin Gebro, Rotigotin Luye, Rotigotin Neuraxpharm, Rotigotin Ucb
- Key facts
- Active substance
- Rotigotine
- Drug class
- Dopamine agonist
- ATC code
- N04BC09
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Neupro 1 mg/24 h transdermal patch / Neupro 3 mg/24 h transdermal patch · Neupro 2 mg/24 h transdermal patch · Neupro 4 mg/24 h transdermal patch / Neupro 6 mg/24 h transdermal patch / Neupro 8 mg/24 h transdermal patch · Neupro / 2 mg/24 h / 4 mg/24 h
- Marketing authorisation holder
- UCB Pharma S.A.
- Information as of
- 2026-10-27
Key facts
Rotigotine is a dopamine agonist delivered through the skin by a transdermal patch. It is used for moderate to severe restless legs syndrome and for Parkinson's disease.
What it is used for
- Symptomatic treatment of moderate to severe idiopathic restless legs syndrome (RLS) in adults
- Idiopathic Parkinson's disease, early stage as monotherapy or with levodopa through to late stages with fluctuations
Dosing
- RLS: start 1 mg/24 h, increase weekly by 1 mg/24 h to a maximum of 3 mg/24 h; reconsider continuation every 6 months
- Early Parkinson's disease: start 2 mg/24 h, increase weekly by 2 mg/24 h to a maximum of 8 mg/24 h
- Advanced Parkinson's disease with fluctuations: start 4 mg/24 h, increase weekly by 2 mg/24 h to a maximum of 16 mg/24 h
- Apply one patch daily at about the same time at a new site; avoid the same site within 14 days
- Withdraw gradually (RLS in steps of 1 mg/24 h, Parkinson's in steps of 2 mg/24 h, preferably every other day)
- No adjustment in renal impairment; caution in severe hepatic impairment
Contraindications
- Hypersensitivity to the active substance or any excipient
- Magnetic resonance imaging or cardioversion (patch backing contains aluminium; remove beforehand)
Important warnings
- Somnolence and sudden sleep onset during daily activities, sometimes without warning; affected patients must not drive
- Impulse control disorders (e.g. pathological gambling, hypersexuality, compulsive buying, binge eating) and dopamine dysregulation syndrome
- Orthostatic hypotension; monitor blood pressure, especially at the start
- RLS: augmentation may occur; avoid doses above the approved range
- Contains sodium metabisulphite (sulphite sensitivity)
Side effects
- In more than 10%: nausea, application site reactions, asthenic conditions and headache
- Dopaminergic effects such as nausea and vomiting at the start, usually mild and transient
- Others: sleep attacks, hallucinations, impulse control disorders, insomnia
Interactions
- Dopamine antagonists (neuroleptics, metoclopramide) may reduce effectiveness; avoid co-administration
- Sedating medicines, other CNS depressants and alcohol: possible additive effects
- No pharmacokinetic interaction with levodopa/carbidopa, domperidone or omeprazole
Pregnancy and breastfeeding
- Should not be used during pregnancy
- Decreases prolactin secretion so inhibition of lactation is expected; breast-feeding should be discontinued
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- NeuproUCB Pharma S.A. · EMEA/H/C/000626
Source: European Medicines Agency (EMA), product information
Austria
- KinparlevOrion Corporation · 1 register entry
- Rotigotin GebroGebro Pharma Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- Rotigotin LuyeLuye Pharma Ag · 1 register entry
- Rotigotin NeuraxpharmNeuraxpharm Arzneimittel Gmbh · 1 register entry
- Rotigotin UcbUcb Pharma S.A. · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Brand names in 14 more European countries
- Denmark
- Kinparlev, Rotigotine Medical Valley
- Finland
- Kinparlev, Rotigotine Medical Valley
- France
- Rotigotine Arrow
- Greece
- Kinparlev
- Iceland
- Neupro, Rotigotine Medical Valley
- Italy
- Rotigotina Doc
- Liechtenstein
- Neupro
- Luxembourg
- Rotigotin Luye
- Netherlands
- Rotigotine Medical Valley, Rotigotine Xiromed
- Norway
- Kinparlev, Neupro, Rotigotine Medical Valley
- Portugal
- Kinparlev, Rotigotina Generis
- Romania
- Kinparlev
- Spain
- Dariante
- Sweden
- Kinparlev, Rotigotine Medical Valley
EMA – Article 57 product data (EU/EEA), 2026-10-28
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Neupro – EPAR, Product Information (OF THE TEXT {MM/YYYY} Detailed information on this medicinal). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/neupro-epar-product-information_en.pdf
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- Wikidata (CC0): ATC N04BC.
Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.