nirsevimab

FDA Drug Profile — BEYFORTUS

Drug Details

Generic Name
nirsevimab
Brand Names
BEYFORTUS
Application Number
BLA761328
Sponsor
Novo Nordisk Production Belgium SA
NDC Codes
7
Dosage Forms
INJECTION, SOLUTION, LIQUID, INJECTION
Routes
INTRAMUSCULAR
Active Ingredients
NIRSEVIMAB

Indications and Usage

1 INDICATIONS AND USAGE BEYFORTUS is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in: Neonates and infants born during or entering their first RSV season. Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. BEYFORTUS is a respiratory syncytial virus (RSV) F protein-directed fusion inhibitor indicated for the prevention of RSV lower respiratory tract disease in: Neonates and infants born during or entering their first RSV season. ( 1 ) Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. ( 1 )