Ontilyv

Lapsed

This medicine's authorisation has lapsed

opicapone

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The European public assessment report for Ontilyv has been updated to reflect that the marketing authorisation is no longer valid.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

Ontilyv : EPAR - Medicine Overview

Reference Number: EMA/784718/2021

Ontilyv : EPAR - Risk management plan summary

Product information

Ontilyv : EPAR - Product Information

Ontilyv : EPAR - All authorised presentations

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:
  • N04
  • N04BX04

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.

Authorisation details

• EMA product number:
  EMEA/H/C/005782
• Marketing authorisation holder:
  Bial Portela & Companhia S.A.

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

• Opinion adopted:
  16/12/2021
• Marketing authorisation issued:
  21/02/2022
• Lapse of marketing authorisation:
  21/02/2025
• Revision:
  2

Assessment history

Changes since initial authorisation of medicine

Ontilyv : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Ontilyv : EPAR - Public Assessment Report

Adopted Reference Number: EMA/129900/2022

CHMP summary of opinion for Ontilyv

Adopted Reference Number: EMA/CHMP/679312/2021