This medicine is authorised for use in the European Union.


Reblozyl is a medicine used to treat anaemia (low red blood cell counts) 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) or of dying. It is used in patients in whom another medicine, erythropoietin, is unsuitable or does not work.
  • 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 the European Medicines Agency’s website (myelodysplastic syndromes: 22 August 2014; beta thalassaemia: 29 July 2014).

The medicine contains the active substance luspatercept.

This EPAR was last updated on 09/10/2023

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Anemia
  • Myelodysplastic Syndromes
  • beta-Thalassemia
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.


This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Bristol Myers Squibb Pharma EEIG
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Plaza 254
Blanchardstown Corporate Park 2
Dublin 15
D15 T867

Product information

24/08/2023 Reblozyl - EMEA/H/C/004444 - IB/0022

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.


Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Other antianemic preparations

Therapeutic indication

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).

Assessment history

Related content

How useful was this page?

Add your rating
2 ratings
1 rating