Synagis

Product manufactured by Medimmune, Llc

Application Nr Approved Date Route Status External Links
BLA103770 None Intramuscular None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

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: • 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, • 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, • 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: • 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, • 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, • 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)

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Palivizumab

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