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 11/11/2021

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
GenericGeneric

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 Pharmaceuticals Limited
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
04/04/2016
Contact address

Mylan Pharmaceuticals Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
Ireland

Product information

19/10/2021 Rasagiline Mylan - EMEA/H/C/004064 - T/0009

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

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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