Xofluza
baloxavir marboxil
Table of contents
Overview
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.
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Xofluza : EPAR - Medicine overview (PDF/119.96 KB)
First published: 22/01/2021
Last updated: 19/01/2023
EMA/886617/2022 -
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Xofluza : EPAR - Risk-management-plan summary (PDF/87.19 KB)
First published: 22/01/2021
Last updated: 19/01/2023
Authorisation details
Product details | |
---|---|
Name |
Xofluza
|
Agency product number |
EMEA/H/C/004974
|
Active substance |
Baloxavir marboxil
|
International non-proprietary name (INN) or common name |
baloxavir marboxil
|
Therapeutic area (MeSH) |
Influenza, Human
|
Additional 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 | |
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Marketing-authorisation holder |
Roche Registration GmbH
|
Revision |
4
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Date of issue of marketing authorisation valid throughout the European Union |
07/01/2021
|
Contact address |
Emil-Barell-Strasse 1 |
Product information
10/01/2023 Xofluza - EMEA/H/C/004974 - X/0008/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.