Xadago

RSS

safinamide

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 26/11/2018

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
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Zambon SpA
Revision
8
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

27/07/2018 Xadago - EMEA/H/C/002396 - IB/0026/G

Contents

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

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.

Assessment history

How useful was this page?

Add your rating