Ontilyv | European Medicines Agency (EMA)

March 29, 2025

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Overview

On 21 February 2025, the marketing authorisation of Ontilyv (opicapone) ceased to be valid in the European Union (EU).

The cessation of validity is due to the fact that the marketing authorisation holder, Bial Portela & Ca. S.A., had not marketed Ontilyv in the EU since its initial marketing authorisation. In accordance with provisions of the sunset clause¹, the marketing authorisation of a medicinal product lapsed if the product had not been marketed in any EU Member State within three years of its initial authorisation.

Bial Portela & Ca. S.A. confirmed that the product had not been marketed due to commercial reasons.

Ontilyv was granted marketing authorisation in the EU on 21 February 2022 for use as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors in adults with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.

The marketing authorisation was initially valid for a 5-year period.

Ontilyv was a duplicate application to Ongentys, which is marketed throughout the European Union. The marketing authorisation holder will maintain the marketing authorisation for Ongentys.

The European public assessment report for Ontilyv has been updated to reflect that the marketing authorisation is no longer valid.

¹ Article 14(5) of Regulation (EC) No 726/2004 (“sunset clause”)

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First published: 07/03/2022Last updated: 28/03/2025

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First published: 07/03/2022Last updated: 28/03/2025

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Product information

English (EN)
(1.42 MB – PDF)

First published: 07/03/2022Last updated: 28/03/2025

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Latest procedure affecting product information:
WS2702

11/07/2024

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).

English (EN)
(105.49 KB – PDF)

First published: 07/03/2022Last updated: 28/03/2025

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Product details

Name of medicine: Ontilyv
Active substance: opicapone
International non-proprietary name (INN) or common name: opicapone
Therapeutic area (MeSH): Parkinson Disease
Anatomical therapeutic chemical (ATC) code

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.

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Overview

Product information

Product details

Pharmacotherapeutic group

Therapeutic indication

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