BENEFIX

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

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 about Nonacog alfa

Medication package inserts

Below package inserts are available for further reading:

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