Leganto

Withdrawn

This medicine's authorisation has been withdrawn

rotigotine

Overview

The marketing authorisation for Leganto has been withdrawn at the request of the marketing-authorisation holder.

Leganto : EPAR - Summary for the public

Product information

Leganto : EPAR - Product Information

Latest procedure affecting product information: WS/1963

14/12/2021

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

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).

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

AdoptedReference Number: EMA/437167/2011

CHMP summary of positive opinion for Leganto

AdoptedReference Number: EMA/259223/2011