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.
Entacapone Orion : EPAR - Summary for the public (PDF/61.65 KB)
First published: 31/08/2011
Last updated: 31/08/2011
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21/10/2021 Entacapone Orion - EMEA/H/C/002440 - WS2096
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.
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.