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Ontilyv

Active substance: opicapone

opicapone

Centralised EU authorisationActive

Marketing holder: Bial Portela & Companhia S.A.

Verified 2026-10-09 · EMA

Analogues in other countries
Composition
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
US 2
  • ONGENTYS
    CAPSULE · OPICAPONE 25 mg/1
    64896-402
    Amneal Pharmaceuticals LLC
  • ONGENTYS
    CAPSULE · OPICAPONE 50 mg/1
    64896-403
    Amneal Pharmaceuticals LLC
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208d-7465-7a9c-94e0-6feecf7adac9,01a12092-49e6-7057-9a0c-9701391f6c66;count=2 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/005782
Registration status
Active
ATC code
N04
Sources
  • product · EMA · EMEA/H/C/005782 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/005782 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/005782 · Verified 2026-10-09