Xofluza (baloxavir marboxil)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- baloxavir marboxil
- Company
- Roche Registration GmbH
- Status
- Authorised
- Therapeutic area
- Influenza, Human
- CHMP opinion
- Thu 12 Nov 2020
- EU approval
- Thu 07 Jan 2021
- Designations
- Additional monitoring
- Application
- EMEA/H/C/004974
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.