Oxbryta
Voxelotor
Table of contents
Overview
Oxbryta is a medicine used to treat haemolytic anaemia (excess breakdown of red blood cells) in patients aged 12 years and older who have sickle cell disease. Oxbryta can be given on its own or together with another medicine for sickle cell disease called hydroxycarbamide.
Sickle cell disease is a genetic disease where individuals produce an abnormal form of haemoglobin (the protein in red blood cells that carries oxygen). The red blood cells become rigid and sticky, and change from being disc-shaped to being crescent-shaped (like a sickle). Sickle cell disease is rare, and Oxbryta was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 18 November 2016. Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu-3-16-1769.
Oxbryta contains the active substance voxelotor.
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List item
Oxbryta : EPAR - Medicine Overview (PDF/119.37 KB)
First published: 17/03/2022
EMA/131392/2022 -
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Oxbryta : EPAR - Risk management plan summary (PDF/165.06 KB)
First published: 17/03/2022
Authorisation details
Product details | |
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Name |
Oxbryta
|
Agency product number |
EMEA/H/C/004869
|
Active substance |
Voxelotor
|
International non-proprietary name (INN) or common name |
Voxelotor
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
B06AX03
|
Additional 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. |
Orphan |
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 | |
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Marketing-authorisation holder |
Pfizer Europe MA EEIG
|
Revision |
4
|
Date of issue of marketing authorisation valid throughout the European Union |
14/02/2022
|
Contact address |
Pfizer Europe MA EEIG |
Product information
08/06/2023 Oxbryta - EMEA/H/C/004869 - T/0007
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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 hematological agents
Therapeutic indication
Oxbryta is indicated for the treatment of haemolytic anaemia due to sickle cell disease (SCD) in adults and paediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide.