ONGENTYS

This brand name is authorized in Austria, Estonia, Spain, Finland, Croatia, Ireland, Italy, Japan, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States

Active ingredients

The drug ONGENTYS contains one active pharmaceutical ingredient (API):

1 Opicapone UNII Y5929UIJ5N - OPICAPONE

Opicapone is a peripheral, selective and reversible catechol-O-methyltransferase (COMT) inhibitor endowed with a high binding affinity (sub-picomolar). Opicapone is indicated as adjunctive therapy to preparations of levodopa/DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease, leading to an increase of levodopa plasma levels thereby improving the clinical response to levodopa. Read about Opicapone

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
ONGENTYS Hard capsule	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
N04BX04		N Nervous system → N04 Anti-parkinson drugs → N04B Dopaminergic agents → N04BX Other dopaminergic agents
Discover more medicines within N04BX04

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: EE	Ravimiamet	Identifier(s): 1722619, 1722620, 1722631, 1722642, 1722653
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 1151066003
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 031480
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 334950, 391526
Country: IE	Health Products Regulatory Authority	Identifier(s): 66925
Country: IT	Agenzia del Farmaco	Identifier(s): 044932010, 044932022, 044932034, 044932046, 044932059, 044932061, 044932073, 044932085, 044932097, 044932109
Country: JP	医薬品医療機器総合機構	Identifier(s): 1169019F1024
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1080640, 1080641, 1080642, 1080643, 1080644, 1080645, 1080646, 1080647, 1080648, 1080649
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100387898, 100387906
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W65877001, W65877002, W65877003, W65877004, W65877005, W65877006
Country: US	FDA, National Drug Code	Identifier(s): 70370-3025, 70370-3050