Xadago
safinamide
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Xadago. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Xadago.
For practical information about using Xadago, patients should read the package leaflet or contact their doctor or pharmacist.
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List item
Xadago : EPAR - Summary for the public (PDF/76.17 KB)
First published: 30/03/2015
Last updated: 30/03/2015
EMA/181382/2015 -
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Xadago : EPAR - Risk-management-plan summary (PDF/110.78 KB)
First published: 30/03/2015
Last updated: 11/05/2021
Authorisation details
Product details | |
---|---|
Name |
Xadago
|
Agency product number |
EMEA/H/C/002396
|
Active substance |
safinamide methanesulfonate
|
International non-proprietary name (INN) or common name |
safinamide
|
Therapeutic area (MeSH) |
Parkinson Disease
|
Anatomical therapeutic chemical (ATC) code |
N04B
|
Publication details | |
---|---|
Marketing-authorisation holder |
Zambon SpA
|
Revision |
13
|
Date of issue of marketing authorisation valid throughout the European Union |
23/02/2015
|
Contact address |
Via Lillo Del Duca 10
20091 Bresso (Milan) Italy |
Product information
19/10/2023 Xadago - EMEA/H/C/002396 - N/0045
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).
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
Xadago is indicated for the treatment of adult patients with idiopathic Parkinson’s disease (PD) as add-on therapy to a stable dose of Levodopa (L-dopa) alone or in combination with other PD medicinal products in mid-to late-stage fluctuating patients.