Entacapone Orion

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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 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 Entacapone Orion.

This EPAR was last updated on 10/11/2021

Authorisation details

Product details
Name
Entacapone Orion
Agency product number
EMEA/H/C/002440
Active substance
entacapone
International non-proprietary name (INN) or common name
entacapone
Therapeutic area (MeSH)
Parkinson Disease
Anatomical therapeutic chemical (ATC) code
N04BX02
Publication details
Marketing-authorisation holder
Orion Corporation
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
18/08/2011
Contact address

Orionintie 1
FI-02200 Espoo
Finland

Product information

21/10/2021 Entacapone Orion - EMEA/H/C/002440 - WS2096

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

Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in adult patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.

Assessment history

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