Reblozyl

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luspatercept

Authorised
This medicine is authorised for use in the European Union.

Overview

Reblozyl is a medicine used to treat anaemia (low red blood cell counts) that requires regular blood transfusions 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 with a very low to moderate risk of their condition developing into acute myeloid leukaemia (a blood cancer) or of dying, and 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).

The medicine contains the active substance luspatercept.

This EPAR was last updated on 27/09/2022

Authorisation details

Product details
Name
Reblozyl
Agency product number
EMEA/H/C/004444
Active substance
Luspatercept
International non-proprietary name (INN) or common name
luspatercept
Therapeutic area (MeSH)
  • Anemia
  • Myelodysplastic Syndromes
  • beta-Thalassemia
Anatomical therapeutic chemical (ATC) code
B03XA06
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.

OrphanOrphan

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
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
25/06/2020
Contact address

Plaza 254
Blanchardstown Corporate Park 2
Dublin 15
D15 T867
Ireland

Product information

12/09/2022 Reblozyl - EMEA/H/C/004444 - IB/0012

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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.

Reblozyl is indicated for the treatment of adult patients with transfusion-dependent anaemia associated with beta thalassaemia.

Assessment history

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