Stalevo

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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 08/02/2022

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
28
Date of issue of marketing authorisation valid throughout the European Union
17/10/2003
Contact address

Orionintie 1
FI-02200 Espoo
Finland

Product information

27/01/2022 Stalevo - EMEA/H/C/000511 - WS2175

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

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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