• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail

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)