Entacapone Orion
entacapone
Table of contents
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.
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 |
Product information
21/10/2021 Entacapone Orion - EMEA/H/C/002440 - 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:
- 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
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.