Indications
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.
Composition
- Active substance
- Baloxavir marboxil
Official product information
The European public assessment report holds the summary of product characteristics and the package leaflet in every EU language.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Medicine
- Xofluza
- Active substance
- Baloxavir marboxil
- Therapeutic area
- Influenza, Human
- Marketing authorisation holder
- Roche Registration GmbH
- Status
- Authorised
- EU authorisation
- 7 Jan 2021
- EMA product number
- EMEA/H/C/004974
EMA designations
- Orphan medicine
- No
- Conditional approval
- No
- Biosimilar
- No
- Generic
- No
- Accelerated assessment
- No
- Additional monitoring
- Yes
- Patient safety information
- No