Beyfortus
Beyfortus ingredients
| Active ingredient | Strength |
|---|---|
| Nirsevimab | 100 mg/mL |
What Beyfortus is used for
The FDA lists the approved uses on the official label (below). In the EU, nirsevimab is approved as Beyfortus for:
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.
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Beyfortus
- Generic name
- Nirsevimab
- Made by
- Sanofi Vaccines US Inc.
- Forms
- Injection
- Given
- Intramuscular
- Drug class
- Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody
- FDA approval
- Biologic licence (BLA) BLA761328
- On the US market since
- 2023
Official information
- Beyfortus prescribing information (FDA label) on DailyMed
- MedlinePlus drug information (search for Nirsevimab)
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Beyfortus?
Beyfortus (Nirsevimab) is a specialist medicine made by Sanofi Vaccines US Inc., approved by the US FDA.
What are the ingredients of Beyfortus?
Beyfortus contains Nirsevimab (100 mg/mL).
Is Beyfortus approved in Europe?
The same active substance is approved in the EU as Beyfortus.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA