ALPROLIX

This brand name is authorized in Austria, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, 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

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