Leganto : EPAR - Summary for the public (PDF/671.07 KB)
First published: 23/06/2011
Last updated: 18/02/2022
|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||
Allée de la Recherche 60
14/12/2021 Leganto - EMEA/H/C/002380 - WS/1963
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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).
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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).