Rasagiline ratiopharm

RSS

rasagiline

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

Overview

This is a summary of the European public assessment report (EPAR) for Rasagiline ratiopharm. 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 Rasagiline ratiopharm.

For practical information about using Rasagiline ratiopharm, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 25/07/2018

Authorisation details

Product details
Name
Rasagiline ratiopharm
Agency product number
EMEA/H/C/003957
Active substance
rasagiline
International non-proprietary name (INN) or common name
rasagiline
Therapeutic area (MeSH)
Parkinson Disease
Anatomical therapeutic chemical (ATC) code
N04BD02
Publication details
Marketing-authorisation holder
Teva B.V.
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
12/01/2015
Contact address
Swensweg 5
2031 GA Haarlem
Netherlands

Product information

21/06/2018 Rasagiline ratiopharm - EMEA/H/C/003957 - WS/1361

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

Rasagiline ratiopharm is indicated for the treatment of idiopathic Parkinson’s disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.

Assessment history

How useful was this page?

Add your rating