United States - English - NLM (National Library of Medicine)

neurocrine biosciences, inc. - opicapone (unii: y5929uij5n) (opicapone - unii:y5929uij5n) - ongentys is indicated as adjunctive treatment to levodopa/carbidopa in patients with parkinson’s disease (pd) experiencing “off” episodes. ongentys is contraindicated in patients with: - concomitant use of non-selective monoamine oxidase (mao) inhibitors [ see drug interactions ( 7.1 ) ] . - pheochromocytoma, paraganglioma, or other catecholamine secreting neoplasms. risk summary there are no adequate data on the developmental risk associated with use of ongentys in pregnant women. in animal studies, oral administration of opicapone during pregnancy resulted in adverse effects on embryofetal development (increased incidence of fetal abnormalities) at clinically relevant plasma exposures in one of two species tested.  in addition, opicapone is always given concomitantly with levodopa/carbidopa, which is known to cause developmental toxicity in rabbits (s ee data ). the background risk of major birth defects and miscarriage in the u.s. general population is 2-4% and 15-20% of clinically recognized pregnancies

European Union - English - EMA (European Medicines Agency)

bial portela & companhia s.a. - opicapone - parkinson disease - anti-parkinson drugs - 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.

Israel - English - Ministry of Health

truemed ltd, israel - opicapone - hard capsule - opicapone 50 mg - opicapone - ongentys 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.

European Union - English - EMA (European Medicines Agency)

bial - portela cª, s.a. - opicapone - parkinson disease - anti-parkinson drugs - ongentys 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.ongentys 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.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

bial pharma uk ltd - opicapone - capsule - 50mg

Australia - English - Department of Health (Therapeutic Goods Administration)

maxx pharma pty ltd - opicapone, quantity: 50 mg - capsule, hard - excipient ingredients: titanium dioxide; pregelatinised starch; erythrosine; gelatin; magnesium stearate; lactose monohydrate; sodium starch glycollate type a; indigo carmine aluminium lake; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; pharmaceutical glaze; dimeticone - ongentys 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.

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

ono pharmaceutical co., ltd. - opicapone - pale red tablet, major axis: approx. 11.6 mm, minor axis: approx. 5.1 mm thickness: approx. 3.6 mm

Ireland - English - HPRA (Health Products Regulatory Authority)

abbvie limited - foslevodopa; foscarbidopa - solution for infusion - dopa and dopa derivatives

European Union - English - EMA (European Medicines Agency)

acorda therapeutics ireland limited - levodopa - parkinson disease - anti-parkinson drugs - inbrija is indicated for the intermittent treatment of episodic motor fluctuations (off episodes) in adult patients with parkinson’s disease (pd) treated with a levodopa/dopa-decarboxylase inhibitor.

Israel - English - Ministry of Health

abbvie biopharmaceuticals ltd, israel - foscarbidopa; foslevodopa - solution for infusion - foslevodopa 240 mg / 1 ml; foscarbidopa 12 mg / 1 ml - treatment of advanced levodopa-responsive parkinson’s disease with severe motor fluctuations and hyperkinesia or dyskinesia when available combinations of parkinson medicinal products have not given satisfactory results.