Leganto
rotigotine
Table of contents
Overview
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.
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) |
|
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
14/01/2021 Leganto - EMEA/H/C/002380 - WS/1963
Contents
- 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
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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).