Ontilyv

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opicapone

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

Overview

Ontilyv is a medicine used to treat adults with Parkinson’s disease, a progressive brain disorder that causes shaking and muscle stiffness, and slows movement.

Ontilyv is used as an add-on in patients who are having fluctuations  in the ability to move while being treated with combination medicines for Parkinson’s disease that contain levodopa and a DOPA decarboxylase inhibitor (DDCI).

Fluctuations happen when the effects of the combination medication wear off and symptoms re-emerge before the next dose is due. They are linked to a reduction in the effect of levodopa. During these motor fluctuations the patient experiences sudden switches between being ‘on’ and able to move, and being ‘off’ and having difficulty moving about. Ontilyv is used when these fluctuations cannot be treated with the standard levodopa‑containing combinations alone.

This medicine is the same as Ongentys, which is already authorised in the EU. The company that makes Ongentys has agreed that its scientific data can be used for Ontilyv (‘informed consent’).

Ontilyv contains the active substance opicapone.

This EPAR was last updated on 25/08/2022

Authorisation details

Product details
Name
Ontilyv
Agency product number
EMEA/H/C/005782
Active substance
opicapone
International non-proprietary name (INN) or common name
opicapone
Therapeutic area (MeSH)
Parkinson Disease
Anatomical therapeutic chemical (ATC) code
  • N04
  • N04BX04
Publication details
Marketing-authorisation holder
Bial Portela & Companhia S.A.
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
21/02/2022
Contact address

Apartado 19 A
Avenida De Siderurgia Nacional 4745-457
Sao Mamede Do Coronado
Portugal

Product information

24/08/2022 Ontilyv - EMEA/H/C/005782 - IB/0006

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Product information documents contain:

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.

Pharmacotherapeutic group

Anti-Parkinson drugs

Therapeutic indication

Ontilyv 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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