Leganto

RSS

rotigotine

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Leganto has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 18/02/2022

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
19
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

14/12/2021 Leganto - EMEA/H/C/002380 - WS/1963

Product information documents contain:

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

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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