What is the generic name?

PALIVIZUMAB

What is the Trade Name for PALIVIZUMAB?

Synagis

What are the Indications for PALIVIZUMAB?

• 1 INDICATIONS AND USAGE 1 INDICATIONS AND USAGE Synagis is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients: ‚Ä¢ with a history of premature birth (less than or equal to 35 weeks gestational age) and who are 6 months of age or younger at the beginning of RSV season, ‚Ä¢ with bronchopulmonary dysplasia (BPD) that required medical treatment within the previous 6 months and who are 24 months of age or younger at the beginning of RSV season, ‚Ä¢ with hemodynamically significant congenital heart disease (CHD) and who are 24 months of age or younger at the beginning of RSV season [see Clinical Studies (14) ] . Limitations of Use: The safety and efficacy of Synagis have not been established for treatment of RSV disease [see Warnings and Precautions (5.4) ] . Synagis is a respiratory syncytial virus (RSV) F protein inhibitor monoclonal antibody indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients: ‚Ä¢ with a history of premature birth (less than or equal to 35 weeks gestational age) and who are 6 months of age or younger at the beginning of RSV season, ‚Ä¢ with bronchopulmonary dysplasia (BPD) that required medical treatment within the previous 6 months and who are 24 months of age or younger at the beginning of RSV season, ‚Ä¢ with hemodynamically significant congenital heart disease (CHD) and who are 24 months of age or younger at the beginning of RSV season. Limitations of Use: The safety and efficacy of Synagis have not been established for treatment of RSV disease. (1)

References: https://open.fda.gov/