Neupro
rotigotine
Table of contents
Overview
This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the scientific discussion (also part of the EPAR).
Authorisation details
Product details | |
---|---|
Name |
Neupro
|
Agency product number |
EMEA/H/C/000626
|
Active substance |
rotigotine
|
International non-proprietary name (INN) or common name |
rotigotine
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
N04BC09
|
Publication details | |
---|---|
Marketing-authorisation holder |
UCB Pharma S.A.
|
Revision |
31
|
Date of issue of marketing authorisation valid throughout the European Union |
15/02/2006
|
Contact address |
Allée de la Recherche 60 |
Product information
08/11/2021 Neupro - EMEA/H/C/000626 - N/0090
This medicine’s product information is available in all official EU languages.
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Anti-Parkinson drugs
Therapeutic indication
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.