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 26/10/2023

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

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Product information documents contain:

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.

Assessment history

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