baloxavir marboxil

This medicine is authorised for use in the European Union.


Xofluza is an antiviral medicine for treating and preventing flu in adults and children from 1 year of age.

As a treatment, Xofluza is only used for uncomplicated flu (flu without serious effects that may require hospital care).

Xofluza contains the active substance baloxavir marboxil.

This EPAR was last updated on 27/07/2023

Authorisation details

Product details
Agency product number
Active substance
Baloxavir marboxil
International non-proprietary name (INN) or common name
baloxavir marboxil
Therapeutic area (MeSH)
Influenza, Human
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Roche Registration GmbH
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen

Product information

10/01/2023 Xofluza - EMEA/H/C/004974 - X/0008/G

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Treatment of influenza

Xofluza is indicated for the treatment of uncomplicated influenza in patients aged 1 year and above.

Post exposure prophylaxis of influenza

Xofluza is indicated for post-exposure prophylaxis of influenza in individuals aged 1 year and above.

Xofluza should be used in accordance with official recommendations.

Assessment history

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