levodopa / carbidopa / entacapone
This is a summary of the European public assessment report (EPAR) for Stalevo. 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 Stalevo.
Stalevo : EPAR - Summary for the public (PDF/59.39 KB)
First published: 14/05/2009
Last updated: 13/10/2011
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25/11/2020 Stalevo - EMEA/H/C/000511 - IG/1303
- 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
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Stalevo is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa / dopa-decarboxylase (DDC)-inhibitor treatment.