The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail


25 milligram(s) Infus/Pdr/Oral Soln

Novartis Europharm LimitedEU/1/10/612/013

Main Information

Trade NameRevolade
Active SubstancesEltrombopag olamine
Strength25 milligram(s)
Dosage FormInfus/Pdr/Oral Soln
Licence HolderNovartis Europharm Limited
Licence NumberEU/1/10/612/013

Group Information

ATC CodeB02BX Other systemic hemostatics
B02BX05 eltrombopag


Licence Issued04/04/2016
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
« Back