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100 milligram(s)/millilitre Oral solution

Nova Laboratories Ireland LimitedEU/1/19/1366/001

Main Information

Trade NameXromi
Active SubstancesHydroxycarbamide
Strength100 milligram(s)/millilitre
Dosage FormOral solution
Licence HolderNova Laboratories Ireland Limited
Licence NumberEU/1/19/1366/001

Group Information

ATC CodeL01XX Other antineoplastic agents
L01XX05 hydroxycarbamide


Licence Issued01/07/2019
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Marketing Status


Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website

Educational Materials - HCP

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