Levodopa/Carbidopa/Entacapone Orion

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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 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 08/02/2022

Authorisation details

Product details
Name
Levodopa/Carbidopa/Entacapone Orion
Agency product number
EMEA/H/C/002441
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
12
Date of issue of marketing authorisation valid throughout the European Union
23/08/2011
Contact address

Orionintie 1
FI-02200 Espoo
Finland

Product information

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

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

Nervous system

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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