Neupro

rotigotine

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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).

What is Neupro?

Neupro is a range of transdermal patches (patches that deliver a medicine across the skin). Each patch releases 1, 2, 3, 4, 6 or 8 mg of the active substance rotigotine over 24 hours.

What is Neupro used for?

Neupro is used to treat the symptoms of the following diseases in adults:

  • Parkinson’s disease. Neupro is used on its own in early-stage disease, or in combination with levodopa (another medicine used in Parkinson’s disease) at any stage of the disease, including the later stages when levodopa starts becoming less effective;
  • moderate to severe restless-legs syndrome, a disorder where the patient has uncontrollable urges to move the limbs to stop uncomfortable, painful or odd sensations in the body, usually at night. Neupro is used when a specific cause for the disorder cannot be identified.

The medicine can only be obtained with a prescription.

How is Neupro used?

Neupro is applied once a day at about the same time every day. The patch is applied to dry, clean, healthy skin on the abdomen (tummy), thigh, hip, side, shoulder or upper arm. The patch remains on the skin for 24 hours and is then replaced by a new one in a different place. The same place must not be used again until two weeks later. The strength of patch to use at the start of treatment depends on the type and stage of the disease being treated. The dose can then be increased every week until an effective dose is reached. A special pack with patches of four different strengths is available to help when starting treatment for early-stage Parkinson’s disease. The maximum dose is 8 mg/24 h for early-stage Parkinson’s disease and 16 mg/24 h for advanced disease. For restless-legs syndrome, the maximum dose is 3 mg/24 h.

How does Neupro work?

The active substance in Neupro, rotigotine, is a dopamine agonist, which means that it imitates the action of dopamine. Dopamine is a messenger substance in the parts of the brain that control movement and coordination. In patients with Parkinson’s disease, the cells that produce dopamine begin to die and the amount of dopamine in the brain decreases. The patients then lose their ability to control their movements reliably. Neupro delivers a constant supply of rotigotine through the skin into the bloodstream. Rotigotine then stimulates the brain as dopamine would, so that patients can control their movement and have fewer of the signs and symptoms of Parkinson’s disease, such as stiffness and slowness of movement. The way rotigotine works in restless-legs syndrome is not fully understood. The syndrome is thought to be caused by problems in the way dopamine works in the brain, which may be improved by rotigotine.

How has Neupro been studied?

In Parkinson’s disease, Neupro has been compared with placebo (a dummy treatment) in four studies involving 830 patients with early-stage disease and 842 patients with advanced disease. Two of these studies also compared Neupro with other dopamine agonists (ropinirole in early-stage disease and pramipexole in advanced disease). The studies in early-stage disease looked at the number of patients who had at least a 20% improvement in symptoms, as measured with a standard symptom questionnaire. The studies in advanced disease measured the length of time during the day that the patients recorded as ‘off’ (when they had too many Parkinson’s disease symptoms to be able to live normally). Two smaller studies comparing Neupro with ropinirole were completed after the medicine’s authorisation.

In moderate to severe restless-legs syndrome, Neupro has been compared with placebo in two main studies involving a total of 963 patients. The main measure of effectiveness was the change in symptoms after six months of treatment with a stable dose, measured using two standard scales.

What benefit has Neupro shown during the studies?

Neupro was more effective than placebo in treating Parkinson’s disease. In early-stage disease, 48 to 52% of the patients using Neupro had an improvement in symptoms, compared with 19 to 30% of those using placebo. Neupro was less effective than ropinirole: an improvement was seen in 70% of the patients receiving ropinirole. In the smaller studies completed later, the effectiveness of Neupro was found to be comparable with ropinirole.

In advanced Parkinson’s disease, patients using Neupro had a greater decrease in their ‘off’ time than those taking placebo (a decrease of 2.1 to 2.7 h with Neupro compared with 0.9 h with placebo). The decrease seen with Neupro was similar to that seen with pramipexole (2.8 h).

In restless-legs syndrome, patients using doses of Neupro between 1 and 3 mg/24 h had a greater improvement than those using placebo in the two studies, as measured on both symptom scales.

What is the risk associated with Neupro?

The most common side effects with Neupro in patients with Parkinson’s disease (seen in more than 1 patient in 10) are somnolence (sleepiness), dizziness, headache, nausea (feeling sick), vomiting, and application-site reactions such as redness, itching and irritation of the skin. In patients with restless-legs syndrome, the most common side effects (seen in more than 1 patient in 10) are nausea, application-site reactions, asthenic conditions (conditions such as tiredness, weakness and feeling unwell) and headache. For the full list of all side effects reported with Neupro, see the package leaflet.

Neupro must not be used in people who are hypersensitive (allergic) to rotigotine or any of the other ingredients. The backing layer of Neupro contains aluminium. To avoid skin burns, Neupro must be removed if the patient has to have magnetic resonance imaging (MRI) or cardioversion (a process that restores the heart’s normal rhythm).

Why has Neupro been approved?

The CHMP decided that Neupro’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Neupro

The European Commission granted a marketing authorisation valid throughout the European Union for Neupro on 15 February 2006.

Name Language First published Last updated
Neupro : EPAR - Summary for the public BG = bălgarski 07/01/2009 12/03/2013
Neupro : EPAR - Summary for the public ES = español 07/01/2009 12/03/2013
Neupro : EPAR - Summary for the public CS = čeština 07/01/2009 12/03/2013
Neupro : EPAR - Summary for the public DA = dansk 07/01/2009 12/03/2013
Neupro : EPAR - Summary for the public DE = Deutsch 07/01/2009 12/03/2013
Neupro : EPAR - Summary for the public ET = eesti keel 07/01/2009 12/03/2013
Neupro : EPAR - Summary for the public EL = elliniká 07/01/2009 12/03/2013
Neupro : EPAR - Summary for the public EN = English 07/01/2009 12/03/2013
Neupro : EPAR - Summary for the public FR = français 07/01/2009 12/03/2013
Neupro : EPAR - Summary for the public IT = italiano 07/01/2009 12/03/2013
Neupro : EPAR - Summary for the public LV = latviešu valoda 07/01/2009 12/03/2013
Neupro : EPAR - Summary for the public LT = lietuvių kalba 07/01/2009 12/03/2013
Neupro : EPAR - Summary for the public HU = magyar 07/01/2009 12/03/2013
Neupro : EPAR - Summary for the public MT = Malti 07/01/2009 12/03/2013
Neupro : EPAR - Summary for the public NL = Nederlands 07/01/2009 12/03/2013
Neupro : EPAR - Summary for the public PL = polski 07/01/2009 12/03/2013
Neupro : EPAR - Summary for the public PT = português 07/01/2009 12/03/2013
Neupro : EPAR - Summary for the public RO = română 07/01/2009 12/03/2013
Neupro : EPAR - Summary for the public SK = slovenčina 07/01/2009 12/03/2013
Neupro : EPAR - Summary for the public SL = slovenščina 07/01/2009 12/03/2013
Neupro : EPAR - Summary for the public FI = suomi 07/01/2009 12/03/2013
Neupro : EPAR - Summary for the public SV = svenska 07/01/2009 12/03/2013

This EPAR was last updated on 26/02/2014 .

Authorisation details

Product details

Product details for Neupro
NameNeupro
Agency product numberEMEA/H/C/000626
Active substance

rotigotine

International non-proprietary name (INN) or common name

rotigotine

Therapeutic area Restless Legs SyndromeParkinson Disease
Anatomical therapeutic chemical (ATC) code N04BC09

Publication details

Publication details for Neupro
Marketing-authorisation holder

UCB Manufacturing Ireland Ltd

Revision17
Date of issue of marketing authorisation valid throughout the European Union15/02/2006

Contact address:

UCB Manufacturing Ireland Ltd
Shannon Industrial Estate
County Clare
Ireland

Product information

Product information

23/01/2014  Neupro -EMEA/H/C/000626 -WS/0450

Name Language First published Last updated
Neupro : EPAR - Product Information SV = svenska 21/12/2009 26/02/2014
Neupro : EPAR - Product Information SV = svenska 21/12/2009 26/02/2014
Neupro : EPAR - Product Information SV = svenska 21/12/2009 26/02/2014
Neupro : EPAR - Product Information SV = svenska 21/12/2009 26/02/2014
Neupro : EPAR - Product Information SV = svenska 21/12/2009 26/02/2014
Neupro : EPAR - Product Information SV = svenska 21/12/2009 26/02/2014
Neupro : EPAR - Product Information SV = svenska 21/12/2009 26/02/2014
Neupro : EPAR - Product Information SV = svenska 21/12/2009 26/02/2014
Neupro : EPAR - Product Information SV = svenska 21/12/2009 26/02/2014
Neupro : EPAR - Product Information SV = svenska 21/12/2009 26/02/2014
Neupro : EPAR - Product Information SV = svenska 21/12/2009 26/02/2014
Neupro : EPAR - Product Information SV = svenska 21/12/2009 26/02/2014
Neupro : EPAR - Product Information SV = svenska 21/12/2009 26/02/2014
Neupro : EPAR - Product Information SV = svenska 21/12/2009 26/02/2014
Neupro : EPAR - Product Information SV = svenska 21/12/2009 26/02/2014
Neupro : EPAR - Product Information SV = svenska 21/12/2009 26/02/2014
Neupro : EPAR - Product Information SV = svenska 21/12/2009 26/02/2014
Neupro : EPAR - Product Information SV = svenska 21/12/2009 26/02/2014
Neupro : EPAR - Product Information SV = svenska 21/12/2009 26/02/2014
Neupro : EPAR - Product Information SV = svenska 21/12/2009 26/02/2014
Neupro : EPAR - Product Information SV = svenska 21/12/2009 26/02/2014
Neupro : EPAR - Product Information SV = svenska 21/12/2009 26/02/2014
Neupro : EPAR - Product Information SV = svenska 21/12/2009 26/02/2014
Neupro : EPAR - Product Information SV = svenska 21/12/2009 26/02/2014
Neupro : EPAR - Product Information SV = svenska 21/12/2009 26/02/2014

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Neupro : EPAR - All Authorised presentations SV = svenska 07/01/2009  
Neupro : EPAR - All Authorised presentations SV = svenska 07/01/2009  
Neupro : EPAR - All Authorised presentations SV = svenska 07/01/2009  
Neupro : EPAR - All Authorised presentations SV = svenska 07/01/2009  
Neupro : EPAR - All Authorised presentations SV = svenska 07/01/2009  
Neupro : EPAR - All Authorised presentations SV = svenska 07/01/2009  
Neupro : EPAR - All Authorised presentations SV = svenska 07/01/2009  
Neupro : EPAR - All Authorised presentations SV = svenska 07/01/2009  
Neupro : EPAR - All Authorised presentations SV = svenska 07/01/2009  
Neupro : EPAR - All Authorised presentations SV = svenska 07/01/2009  
Neupro : EPAR - All Authorised presentations SV = svenska 07/01/2009  
Neupro : EPAR - All Authorised presentations SV = svenska 07/01/2009  
Neupro : EPAR - All Authorised presentations SV = svenska 07/01/2009  
Neupro : EPAR - All Authorised presentations SV = svenska 07/01/2009  
Neupro : EPAR - All Authorised presentations SV = svenska 07/01/2009  
Neupro : EPAR - All Authorised presentations SV = svenska 07/01/2009  
Neupro : EPAR - All Authorised presentations SV = svenska 07/01/2009  
Neupro : EPAR - All Authorised presentations SV = svenska 07/01/2009  
Neupro : EPAR - All Authorised presentations SV = svenska 07/01/2009  
Neupro : EPAR - All Authorised presentations SV = svenska 07/01/2009  
Neupro : EPAR - All Authorised presentations SV = svenska 07/01/2009  
Neupro : EPAR - All Authorised presentations SV = svenska 07/01/2009  

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.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Neupro : EPAR - Procedural steps taken before authorisation SV = svenska 09/03/2006  
Neupro : EPAR - Scientific Discussion SV = svenska 09/03/2006  

Authorised

This medicine is approved for use in the European Union

More information on Neupro