Leganto
rotigotine
Table of contents
Overview
The marketing authorisation for Leganto has been withdrawn at the request of the marketing-authorisation holder.
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. |
Product information
14/12/2021 Leganto - EMEA/H/C/002380 - WS/1963
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).
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).