REBLOZYL

This brand name is authorized in United States. It is also authorized in Austria, Canada, Croatia, Cyprus, Estonia, Finland, France, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Spain, Turkey.

Active ingredients

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

1
UNII AQK7UBA1LS - LUSPATERCEPT
 

Luspatercept, an erythroid maturation agent, is a recombinant fusion protein that binds selected transforming growth factor-β (TGF-β) superfamily ligands. By binding to specific endogenous ligands (e.g. GDF-11, activin B) luspatercept inhibits Smad2/3 signalling, resulting in erythroid maturation through differentiation of late-stage erythroid precursors (normoblasts) in the bone marrow.

 
Read more about Luspatercept

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 REBLOZYL Powder for solution for injection MPI, EU: SmPC European Medicines Agency (EU)
 REBLOZYL Powder for solution for injection / infusion MPI, US: SPL/PLR FDA, National Drug Code (US)

Medicine classification

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

ATC Group Classification
B03XA06 B Blood and blood forming organs → B03 Antianemic preparations → B03X Other antianemic preparations → B03XA Other antianemic preparations
Discover more medicines within B03XA06

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 02505541, 02505568
EE Ravimiamet 1821912, 1821923
ES Centro de información online de medicamentos de la AEMPS 1201452001, 1201452002
FI Lääkealan turvallisuus- ja kehittämiskeskus 473722, 598825
FR Base de données publique des médicaments 60175591, 62508169
IL מִשְׂרַד הַבְּרִיאוּת 8784, 8785
IT Agenzia del Farmaco 048905018, 048905020
LT Valstybinė vaistų kontrolės tarnyba 1090725, 1090726
NL Z-Index G-Standaard, PRK 203971, 203998
PL Rejestru Produktów Leczniczych 100438911, 100438928
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W67355001, W67356001
TR İlaç ve Tıbbi Cihaz Kurumu 8699726269406, 8699726269505
US FDA, National Drug Code 59572-711, 59572-775

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