Israel - English - Ministry of Health

bristol, myers squibb (israel) limited, israel - luspatercept - powder for solution for injection - luspatercept 25 mg - luspatercept - reblozyl is indicated for the treatment of adult patients with transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (mds) with ring sideroblasts, who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy.reblozyl is indicated in adults for the treatment of anaemia associated with transfusion dependent and non-transfusion-dependent beta-thalassaemia

Israel - English - Ministry of Health

bristol, myers squibb (israel) limited, israel - luspatercept - powder for solution for injection - luspatercept 75 mg - luspatercept - reblozyl is indicated for the treatment of adult patients with transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (mds) with ring sideroblasts, who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy.reblozyl is indicated in adults for the treatment of anaemia associated with transfusion dependent and non-transfusion-dependent beta-thalassaemia

United States - English - NLM (National Library of Medicine)

celgene corporation - luspatercept (unii: aqk7uba1ls) (luspatercept - unii:aqk7uba1ls) - reblozyl is indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (rbc) transfusions. reblozyl is indicated for the treatment of anemia without previous erythropoiesis stimulating agent use (esa-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (mds) who may require regular red blood cell (rbc) transfusions. reblozyl is indicated for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (mds-rs) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (mds/mpn-rs-t). reblozyl is not indicated for use as a substitute for rbc transfusions in patients who require immediate correction of anemia. none. risk summary based on findings in animal reproduction studies, reblozyl may cause fetal harm when administered

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

dksh malaysia sdn. bhd. - luspatercept -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

dksh malaysia sdn. bhd. - luspatercept -

European Union - English - EMA (European Medicines Agency)

bristol myers squibb pharma eeig - luspatercept - anemia; myelodysplastic syndromes; beta-thalassemia - other antianemic preparations - reblozyl is indicated for the treatment of adult patients with transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (mds) with ring sideroblasts, who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy (see section 5.1).reblozyl is indicated in adults for the treatment of anaemia associated with transfusion dependent and non transfusion dependent beta thalassaemia (see section 5.1).

Canada - English - Health Canada

celgene inc - luspatercept - powder for solution - 25mg - luspatercept 25mg - hematopoietic agents

Canada - English - Health Canada

celgene inc - luspatercept - powder for solution - 75mg - luspatercept 75mg - antianemia drugs

Australia - English - Department of Health (Therapeutic Goods Administration)

celgene pty ltd - luspatercept, quantity: 75 mg - injection, powder for - excipient ingredients: citric acid monohydrate; sodium citrate dihydrate; hydrochloric acid; sucrose; polysorbate 80; sodium hydroxide - reblozyl 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

celgene pty ltd - luspatercept, quantity: 25 mg - injection, powder for - excipient ingredients: polysorbate 80; sucrose; sodium citrate dihydrate; sodium hydroxide; hydrochloric acid; citric acid monohydrate - reblozyl 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.