ALPROLIX

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

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 more about Eftrenonacog alfa

Medication package inserts

Below package inserts are available for further reading:

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