EMEA-002440-PIP01-18-M03

Invented name	Xofluza
Active substance	Baloxavir marboxil
Therapeutic area	Infectious diseases
Decision number	P/0383/2022
PIP number	EMEA-002440-PIP01-18-M03
Pharmaceutical form(s)	Film-coated tablet Granules for oral suspension
Condition(s) / indication(s)	Prevention of influenza infection Treatment of influenza
Route(s) of administration	Oral use
Contact for public enquiries	Roche Registration GmbH Tel. +41 6169 79411 E-mail: global.paediatrics@roche.com
Decision type	PM: decision on the application for modification of an agreed PIP

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