baloxavir marboxil

Table of contents


On 10 November 2022, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Xofluza. The marketing authorisation holder for this medicinal product is Roche Registration GmbH.

The CHMP adopted a change to the existing indications to include the treatment of paediatric patients from 1 year of age.

For information, the full indications for Xofluza will be as follows:1

Treatment of influenza

Xofluza is indicated for the treatment of uncomplicated influenza in patients aged 1 12 years and above.

Post exposure prophylaxis of influenza

Xofluza is indicated for post-exposure prophylaxis of influenza in individuals aged 1 12 years and above.

Xofluza should be used in accordance with official recommendations.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

1 New text in bold, removed text as strikethrough 

Key facts

Agency product number
International non-proprietary name (INN) or common name
  • baloxavir marboxil
Active substance
  • Baloxavir marboxil
Therapeutic area
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.

Date opinion adopted
Company name
Roche Registration GmbH
Application type

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