Rasagiline ratiopharm
rasagiline
Table of contents
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.
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Rasagiline ratiopharm : EPAR - Summary for the public (PDF/77.17 KB)
First published: 02/03/2015
Last updated: 02/03/2015
EMA/723435/2014 -
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Rasagiline ratiopharm : EPAR - Risk-management-plan summary (PDF/51.54 KB)
First published: 02/03/2015
Last updated: 02/03/2015
EMA/744222/2014
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 |
8
|
Date of issue of marketing authorisation valid throughout the European Union |
12/01/2015
|
Contact address |
Swensweg 5
2031 GA Haarlem Netherlands |
Product information
21/10/2021 Rasagiline ratiopharm - EMEA/H/C/003957 - N/0020
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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 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.