Comtess

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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). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 05/11/2021

Authorisation details

Product details
Name
Comtess
Agency product number
EMEA/H/C/000170
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
28
Date of issue of marketing authorisation valid throughout the European Union
16/09/1998
Contact address

Orionintie 1
FI-02200 Espoo
Finland

Product information

21/10/2021 Comtess - EMEA/H/C/000170 - WS2096

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

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 patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.

Assessment history

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