Beyfortus
What Beyfortus is used 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.
Approved use, as published by the European Medicines Agency.
What the labels mean
- PRIME: a priority medicine that the EMA supported early because it may meet an unmet need.
Key facts
- Brand
- Beyfortus
- Active substance
- nirsevimab
- Medicine group
- Immune sera and immunoglobulins
- ATC code
- J06BD08
- Marketing authorisation holder
- Sanofi Winthrop Industrie
- Authorised in the EU since
- 2022
Official information
In the USA
Same active substance: Beyfortus
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 used 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 sev…
What is the active substance in Beyfortus?
Beyfortus contains nirsevimab.
Who makes Beyfortus?
The EU marketing authorisation holder is Sanofi Winthrop Industrie.
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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