Ongentys

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opicapone

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 02/02/2017

Authorisation details

Product details
Name
Ongentys
Agency product number
EMEA/H/C/002790
Active substance
opicapone
International non-proprietary name (INN) or common name
opicapone
Therapeutic area (MeSH)
Parkinson Disease
Anatomical therapeutic chemical (ATC) code
N04
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Bial - Portela Cª, S.A.
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
23/06/2016
Contact address
Av. da Siderurgia Nacional S.
Mamede do Coronado 4745-457
Portugal

Product information

16/01/2017 Ongentys - EMEA/H/C/002790 - IB/0003G

Contents

  • 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.

Pharmacotherapeutic group

Anti Parkinson drugs

Therapeutic indication

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.

Assessment history

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