ALPROLIX

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

Active ingredients

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

1 Eftrenonacog alfa UNII 02E00T2QDE - EFTRENONACOG ALFA

Eftrenonacog alfa is a long-acting, fully recombinant, fusion protein comprising human coagulation factor IX covalently linked to the Fc domain of human immunoglobulin G1, and produced by recombinant DNA technology. Haemophilia B is an X-linked hereditary disorder of blood coagulation due to decreased levels of factor IX and results in bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma. By replacement therapy the plasma level of factor IX is increased thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies. Read about Eftrenonacog alfa

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
ALPROLIX 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: CA	Health Products and Food Branch	Identifier(s): 02422913, 02422921, 02422948, 02422956
Country: EE	Ravimiamet	Identifier(s): 1718513, 1718524, 1718535, 1718546, 1718557
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 1161098001, 1161098002, 1161098003, 1161098004, 1161098005
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 030253, 397482, 445900, 482037, 519054
Country: FR	Base de données publique des médicaments	Identifier(s): 60256036, 64611260, 64832013, 66430312, 68071018
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 335061, 335091, 335095, 335099, 335839
Country: HK	Department of Health Drug Office	Identifier(s): 67045, 67046, 67047, 67048
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 9003, 9004, 9005
Country: JP	医薬品医療機器総合機構	Identifier(s): 6343441D1028, 6343441D2024, 6343441D3020, 6343441D4027, 6343441D5023, 6343441D6020
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1080364, 1080365, 1080366, 1080367, 1080368
Country: NL	Z-Index G-Standaard	Identifier(s): 14281910, 14281929, 14281937
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 132314, 132322, 132330, 132349, 132357
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 17335, 17336, 17337, 17338, 17339, 21326
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100369848, 100369860, 100369877, 100369883, 100369890
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W63105001, W63106001, W63107001, W63108001, W63109001
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8683125910076, 8683125910083, 8683125910090, 8683125910106, 8683125910113