Leganto

Withdrawn

This medicine's authorisation has been withdrawn

rotigotine

Overview

On 14 December 2021, the European Commission withdrew the marketing authorisation for Leganto (rotigotine) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, UCB Pharma S.A., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Leganto was granted marketing authorisation in the EU on 16 June 2011 for the treatment of restless legs syndrome and Parkinson´s disease. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2016. 

Leganto was a duplicate of Neupro, which is marketed in several EU countries. 

The European Public Assessment Report (EPAR) for Leganto is updated to indicate that the marketing authorisation is no longer valid.

Leganto : EPAR - Summary for the public

Product information

Leganto : EPAR - Product Information

Leganto : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Leganto
• 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

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).

Authorisation details

• EMA product number:
  EMEA/H/C/002380
• Marketing authorisation holder:
  UCB Pharma S.A.

  Allée de la Recherche 60; B-1070 Bruxelles; Belgium

• Opinion adopted:
  14/04/2011
• Marketing authorisation issued:
  16/06/2011
• Revision:
  19

Assessment history

Changes since initial authorisation of medicine

Leganto : EPAR - Procedural steps taken and scientific information after authorisation

Leganto-H-C-PSUSA-00002667-201702 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMA/12301/2018

Leganto-H-C-2380-P46-017 : EPAR - Assessment Report

Adopted

Leganto- H-C-2380-PSUV-0013 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/CHMP/714236/2014

Initial marketing authorisation documents

Leganto : EPAR - Public assessment report

Adopted Reference Number: EMA/437167/2011

CHMP summary of positive opinion for Leganto

Adopted Reference Number: EMA/259223/2011