This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 24/03/2023

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Anemia, Sickle Cell
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Nova Laboratories Ireland Limited
Date of issue of marketing authorisation valid throughout the European Union
Contact address

3rd Floor, Ulysses House
Foley Street
Dublin 1, D01 W2T2

Product information

06/02/2023 Xromi - EMEA/H/C/004837 - 0018/G

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

Antineoplastic agents

Therapeutic indication

Prevention of vaso-occlusive complications of sickle cell disease in patients over 2 years of age

Assessment history

How useful was this page?

Add your rating