Beyfortus (nirsevimab)
- Region
- 🇪🇺 EU
- Active substance
- nirsevimab
- Company
- Sanofi Winthrop Industrie
- Status
- Authorised
- CHMP opinion
- Thu 15 Sep 2022
- EU approval
- Mon 31 Oct 2022
- Designations
- PRIME, Additional monitoring
- Application
- EMEA/H/C/005304
- ATC
- J06BD08
- Official record
- www.ema.europa.eu
Indication
Beyfortus is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in:i. Neonates and infants during their first RSV season.ii. Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season (see section 5.1).Beyfortus should be used in accordance with official recommendations. Beyfortus is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in:i. Neonates and infants during their first RSV season.ii. Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season (see section 5.1).Beyfortus 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.