Ontilyv
opicapone
Table of contents
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.
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Ontilyv : EPAR - Medicine Overview (PDF/188.62 KB)
First published: 07/03/2022
EMA/784718/2021 -
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Ontilyv : EPAR - Risk management plan summary (PDF/173.55 KB)
First published: 07/03/2022
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 |
|
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 |
Product information
24/08/2022 Ontilyv - EMEA/H/C/005782 - IB/0006
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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.
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.