ORFADIN

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

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 more about Nitisinone

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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