Leganto

RSS

rotigotine

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Leganto. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Leganto.

This EPAR was last updated on 08/05/2018

Authorisation details

Product details
Name
Leganto
Agency product number
EMEA/H/C/002380
Active substance
rotigotine
International non-proprietary name (INN) or common name
rotigotine
Therapeutic area (MeSH)
  • Restless Legs Syndrome
  • Parkinson Disease
Anatomical therapeutic chemical (ATC) code
N04BC09
Publication details
Marketing-authorisation holder
UCB Pharma S.A.  
Revision
16
Date of issue of marketing authorisation valid throughout the European Union
16/06/2011
Contact address
UCB Pharma S.A.
Allee de la Recherche 60
B-1070 Bruxelles
Belgium

Product information

24/04/2018 Leganto - EMEA/H/C/002380 - IAIN/0028

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.

Pharmacotherapeutic group

Anti Parkinson drugs

Therapeutic indication

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).

Assessment history

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