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EMA Product

Reblozyl

Product approved by European Medicines Agency (EU)

Basic Information

Reblozyl

Regulatory Information

EMEA/H/C/004444

Authorised

June 25, 2020

April 30, 2020

9

October 9, 2024

Company Information

Ireland

Plaza 254 Blanchardstown Corporate Park 2 Dublin 15 D15 T867

Bristol-Myers Squibb Pharma EEIG

Drug Classification

Orphan MedicineAdditional Monitoring

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication Reblozyl is indicated in adults for the treatment of transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS). Reblozyl is indicated in adults for the treatment of anaemia associated with transfusion dependent and non transfusion dependent beta thalassaemia. Reblozyl is indicated in adults for the treatment of transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS). Reblozyl is indicated in adults for the treatment of anaemia associated with transfusion dependent and non transfusion dependent beta thalassaemia.

Overview Summary

Reblozyl is a medicine used to treat anaemia (low levels of red blood cells) in adults with the following blood disorders: - myelodysplastic syndromes, a group of conditions where too few blood cells are produced by the bone marrow. Reblozyl is used in patients who need regular blood transfusions and who have a very low to moderate risk of their condition developing into acute myeloid leukaemia (a blood cancer); - beta thalassaemia, a genetic condition in which patients cannot make enough beta globin, a component of haemoglobin (the protein in red blood cells that carries oxygen around the body). These diseases are rare, and Reblozyl was designated an ‘orphan medicine’ (a medicine used in rare diseases). Further information on the orphan designations can be found on ( [myelodysplastic syndromes](/en/medicines/human/orphan-designations/eu-3-14-1331): 22 August 2014; [beta thalassaemia](https://data.ec.europa.eu/ewp/media/f8bd6c6d-3535-49cd-999e-3cc2b4755999): 29 July 2014). The medicine contains the active substance luspatercept.

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