Palivizumab
Product Approval Information - Licensing Action
Proper name: Palivizumab
Tradename: Synagis
Manufacturer: MedImmune, Inc, Gaithersburg, MD, License #1252
Indication for Use: Prophylaxis of serious lower respiratory tract disease, caused by respiratory syncytial virus, in pediatric patients at high risk of RSV disease
Approval Date: 6/19/98
Type of submission: Biologics license application
Approval Letter
(PDF),
(Text)
SBA (PDF)
Reviews (PDF)
Clinical Review (56 pages)
CMC Review (27 pages)
Pharmacology Review (21 pages)
Product Review (71 pages) -
Part I,
Part II,
Part III
Statistical Review (19 pages)
Talk Paper
Last Updated: 3/5/2001
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Updated: September 25, 2003 |