Stalevo

RSS

levodopa / carbidopa / entacapone

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Stalevo. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Stalevo.

This EPAR was last updated on 14/03/2018

Authorisation details

Product details
Name
Stalevo
Agency product number
EMEA/H/C/000511
Active substance
  • levodopa
  • carbidopa
  • entacapone
International non-proprietary name (INN) or common name
levodopa / carbidopa / entacapone
Therapeutic area (MeSH)
Parkinson Disease
Anatomical therapeutic chemical (ATC) code
N04BA03
Publication details
Marketing-authorisation holder
Orion Corporation
Revision
23
Date of issue of marketing authorisation valid throughout the European Union
17/10/2003
Contact address
Orionintie 1
FI-02200 Espoo
Finland

Product information

08/02/2018 Stalevo - EMEA/H/C/000511 - WS/1327

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

Stalevo is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa / dopa-decarboxylase (DDC)-inhibitor treatment.

Assessment history

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