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
|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||
Av. da Siderurgia Nacional S.
Mamede do Coronado 4745-457
13/05/2022 Ongentys - EMEA/H/C/002790 - N/0049
This medicine’s product information is available in all official EU languages.
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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.
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.