Xromi

RSS

hydroxycarbamide

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

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.

This EPAR was last updated on 08/07/2019

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
Date of issue of marketing authorisation valid throughout the European Union
01/07/2019
Contact address

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

Product information

Xromi - EMEA/H/C/004837 -

Contents

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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

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

Assessment history

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