Azilect

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). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 11/07/2018

Authorisation details

Product details
Name
Azilect
Agency product number
EMEA/H/C/000574
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 Pharma GmbH
Revision
20
Date of issue of marketing authorisation valid throughout the European Union
21/02/2005
Contact address
Teva B.V.
Swensweg 5
2031GA Haarlem
Netherlands

Product information

21/06/2018 Azilect - EMEA/H/C/000574 - IA/0080/G

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

Azilect 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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