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.
Rasagiline Mylan : EPAR - Summary for the public (PDF/90.46 KB)
First published: 29/04/2016
Last updated: 29/04/2016
Rasagiline Mylan : EPAR - Risk-management-plan summary
First published: 25/01/2016
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
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.
|Date of issue of marketing authorisation valid throughout the European Union||
18/05/2016 Rasagiline Mylan - EMEA/H/C/004064 - IAIN/0001/G
- 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.
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.