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Xofluza



Roche Registration GmbHEU/1/20/1500/003

Main Information

Trade NameXofluza
Active SubstancesBaloxavir Marboxil
Dosage FormFilm-coated tablet
Licence HolderRoche Registration GmbH
Licence NumberEU/1/20/1500/003

Group Information

ATC CodeJ05AX25 baloxavir marboxil

Status

License statusAuthorised
Licence Issued07/01/2021
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing StatusUnknown

Documents

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