BENEFIX

This brand name is authorized in Austria, Brazil, Canada, Croatia, Cyprus, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.

Active ingredients

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

1	Nonacog alfa UNII 382L14738L - COAGULATION FACTOR IX RECOMBINANT HUMAN
	Nonacog alfa is a recombinant coagulation factor IX. Recombinant coagulation factor IX is a recombinant DNA-based protein therapeutic which has structural and functional characteristics comparable to endogenous factor IX. Haemophilia B is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor IX. By replacement therapy the plasma levels of factor IX is increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.
	Read more about Nonacog alfa

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
BENEFIX Powder and solvent for solution for injection	MPI, EU: SmPC	European Medicines Agency (EU)

Medicine classification

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

ATC Group		Classification
B02BD04	Coagulation factor IX	B Blood and blood forming organs → B02 Antihemorrhagics → B02B Vitamin K and other hemostatics → B02BD Blood coagulation factors
Discover more medicines within B02BD04

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
BR	Câmara de Regulação do Mercado de Medicamentos	522720050085517, 522720050085617, 522720050085717, 522720050085817
CA	Health Products and Food Branch	02293773, 02293781, 02293803, 02392984
EE	Ravimiamet	1316023, 1397471, 1469583, 1469594, 1592906, 1744950
ES	Centro de información online de medicamentos de la AEMPS	197047008, 97047004, 97047005, 97047006, 97047007
FI	Lääkealan turvallisuus- ja kehittämiskeskus	075715, 075724, 075733, 545221
FR	Base de données publique des médicaments	60839455, 61613014, 62084553, 63965053, 65424737
GB	Medicines & Healthcare Products Regulatory Agency	128660, 217014, 48464, 48467, 48470
HK	Department of Health Drug Office	46237, 46238, 46239, 60194
IL	מִשְׂרַד הַבְּרִיאוּת	6728, 6729, 6730
JP	医薬品医療機器総合機構	6343438D1026, 6343438D2022, 6343438D3029, 6343438D4025
LT	Valstybinė vaistų kontrolės tarnyba	1027703, 1027705, 1027707, 1027708, 1067340, 1082616
NL	Z-Index G-Standaard	14281910, 14281929, 14281937
NL	Z-Index G-Standaard, PRK	52884, 52892, 52906, 84883
NZ	Medicines and Medical Devices Safety Authority	12529, 16447, 8744, 8745, 8746
PL	Rejestru Produktów Leczniczych	100177882, 100177899, 100177907, 100177913, 100288044, 100386433
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W64925001, W64926001, W64927001, W64928001
SG	Health Sciences Authority	13803P, 13804P, 13805P, 13806P
TN	Direction de la Pharmacie et du Médicament	8063121H, 8063122H, 8063123H
TR	İlaç ve Tıbbi Cihaz Kurumu	8681308274441, 8681308274458, 8681308274465, 8681308274472
ZA	Health Products Regulatory Authority	35/8.1/0234, 35/8.1/0235, 35/8.1/0236