Xromi
hydroxycarbamide
Table of contents
Overview
Xromi is a medicine used in adults, adolescents and children over two years of age who have sickle cell disease, a genetic disease where the red blood cells become rigid and sticky, and change from being disc-shaped to being crescent-shaped (like a sickle). Xromi is used to prevent so-called vaso-occlusive complications – problems that happen when blood vessels become blocked by the abnormal red blood cells, restricting the flow of blood to parts of the body.
Xromi is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance, but is given as a liquid to be swallowed rather than as capsules and is authorised for different uses. The reference medicine for Xromi is Hydrea.
The active substance in Xromi is hydroxycarbamide.
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List item
Xromi : EPAR - Medicine overview (PDF/84.68 KB)
First published: 08/07/2019
EMA/244342/2019 -
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List item
Xromi : EPAR - Risk-management-plan summary (PDF/368.69 KB)
First published: 08/07/2019
Last updated: 08/06/2022
Authorisation details
Product details | |
---|---|
Name |
Xromi
|
Agency product number |
EMEA/H/C/004837
|
Active substance |
hydroxycarbamide
|
International non-proprietary name (INN) or common name |
hydroxycarbamide
|
Therapeutic area (MeSH) |
Anemia, Sickle Cell
|
Anatomical therapeutic chemical (ATC) code |
L01XX05
|
Publication details | |
---|---|
Marketing-authorisation holder |
Nova Laboratories Ireland Limited
|
Revision |
6
|
Date of issue of marketing authorisation valid throughout the European Union |
01/07/2019
|
Contact address |
3rd Floor, Ulysses House |
Product information
06/02/2023 Xromi - EMEA/H/C/004837 - 0018/G
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
Antineoplastic agents
Therapeutic indication
Prevention of vaso-occlusive complications of sickle cell disease in patients over 2 years of age