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.
Leganto : EPAR - Summary for the public (PDF/83.23 KB)
First published: 23/06/2011
Last updated: 12/03/2013
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
UCB Pharma S.A.
|Date of issue of marketing authorisation valid throughout the European Union||
11/04/2019 Leganto - EMEA/H/C/002380 - WS/1381
- 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
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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).