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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08/10/2020 Entacapone Orion - EMEA/H/C/002440 - IG/1277
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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.