ORFADIN

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

Active ingredients

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

1 Nitisinone UNII K5BN214699 - NITISINONE

Nitisinone is a competitive inhibitor of 4-hydroxyphenylpyruvate dioxygenase, an enzyme which precedes fumarylacetoacetate hydrolase in the tyrosine catabolic pathway. By inhibiting the normal catabolism of tyrosine in patients with hereditary tyrosinemia type 1 (HT-1), nitisinone prevents the accumulation of the toxic intermediates maleylacetoacetate and fumarylacetoacetate. Read about Nitisinone

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
ORFADIN Capsule / Oral suspension	FDA, National Drug Code (US)	MPI, US: SPL/PLR

Medicine classification

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

ATC code	Group title	Classification
A16AX04	Nitisinone	A Alimentary tract and metabolism → A16 Other alimentary tract and metabolism products → A16A Other alimentary tract and metabolism products → A16AX Various alimentary tract and metabolism products
Discover more medicines within A16AX04

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
Country: CA	Health Products and Food Branch	Identifier(s): 02459698, 02459701, 02459728, 02459736, 02469693
Country: EE	Ravimiamet	Identifier(s): 1197738, 1197749, 1214806, 1693504, 1693515
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 04303001, 04303002, 04303003, 104303004, 104303005
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 028328, 151239, 153615, 463724, 528233
Country: FR	Base de données publique des médicaments	Identifier(s): 60459499, 64147632, 64748145, 64861673, 66880925
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 307766, 307769, 95738, 96016, 96021
Country: IE	Health Products Regulatory Authority	Identifier(s): 88393, 88394, 88395, 88414, 88421
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 6924, 6925, 6926
Country: IT	Agenzia del Farmaco	Identifier(s): 036870018, 036870020, 036870032, 036870044
Country: JP	医薬品医療機器総合機構	Identifier(s): 3999036M1029, 3999036M2025, 3999036M3021
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1030353, 1030354, 1030355, 1076837, 1078237
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 128678, 128686, 79987, 79995, 80004
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100115674, 100115846, 100116076, 100342387, 100344110
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W51622001, W51627001, W51629001
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 16673011H, 16673012H, 16673013H, 16673014H
Country: US	FDA, National Drug Code	Identifier(s): 66658-102, 66658-105, 66658-110, 66658-120, 66658-204