Rasagiline Mylan

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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 Mylan. 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 Mylan.

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

This EPAR was last updated on 22/06/2016

Authorisation details

Product details
Name
Rasagiline Mylan
Agency product number
EMEA/H/C/004064
Active substance
rasagiline tartrate
International non-proprietary name (INN) or common name
rasagiline
Therapeutic area (MeSH)
Parkinson Disease
Anatomical therapeutic chemical (ATC) code
N04BD02
Generic

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Mylan S.A.S.
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
04/04/2016
Contact address
117 Allée des Parcs
69800 Saint Priest
France

Product information

18/05/2016 Rasagiline Mylan - EMEA/H/C/004064 - IAIN/0001/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

Rasagiline Mylan 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

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