REBLOZYL (Celgene Pty Ltd)
Product name
REBLOZYL
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
250 (255 working days)
Active ingredients
luspatercept
Registration type
NCE/NBE
Indication
REBLOZYL (powder for injection) is indicated for the treatment of adult patients with transfusion-dependent anaemia (requiring 2 or more RBC units over 8 weeks) due to very low, low and intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS).
REBLOZYL is indicated for the treatment of adult patients with transfusion-dependent anaemia associated with beta thalassaemia.
Limitation of Use
REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anaemia.