Levodopa/Carbidopa/Entacapone Orion


levodopa / carbidopa / entacapone

This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for Levodopa/Carbidopa/Entacapone Orion. 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 Levodopa/Carbidopa/Entacapone Orion.

This EPAR was last updated on 15/12/2020

Authorisation details

Product details
Levodopa/Carbidopa/Entacapone Orion
Agency product number
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
Publication details
Marketing-authorisation holder
Orion Corporation
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Orionintie 1
FI-02200 Espoo

Product information

25/11/2020 Levodopa/Carbidopa/Entacapone Orion - EMEA/H/C/002441 - IG/1303


  • 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

Nervous sytem

Therapeutic indication

Levodopa/Carbidopa/Entacapone Orion 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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