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U.S. Department of Health and Human Services

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Palivizumab Product Approval Information - Licensing Action

Proper name: Palivizumab
Tradename: Synagis
Manufacturer: MedImmune, Inc, Gaithersburg, MD, License #1252
Revise Package Insert: Revise Warnings and Adverse Reactions sections to include anaphylaxis and to revise the Immunogenicity subsection
Approval Date: 10/23/2002
Type of submission: Biologics license application supplement

 


Approval Letter (PDF)

Label (PDF)