This is a summary of the European public assessment report (EPAR) for Ongentys. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Ongentys.
For practical information about using Ongentys, patients should read the package leaflet or contact their doctor or pharmacist.
Ongentys : EPAR - Summary for the public (PDF/93.41 KB)
First published: 01/07/2016
Last updated: 01/07/2016
Ongentys : EPAR - Risk-management-plan summary
First published: 20/11/2015
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Bial - Portela Cª, S.A.
|Date of issue of marketing authorisation valid throughout the European Union||
16/01/2017 Ongentys - EMEA/H/C/002790 - IB/0003G
- 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.
Ongentys is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.Ongentys is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.