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Food and
Drug Administration
Vaccines and Related Biological Products Advisory Committee
February 20, 2008
Briefing Information
Topic 1
Sponsor
Disclaimer
The statements contained in this document(s) are those of
the product's sponsor, not FDA, and FDA does not necessarily
agree with the sponsor's statements. FDA has not made a final
determination about the safety or effectiveness of the product
described in this document.
GlaxoSmithKline Biologicals Briefing Document (pdf)
FDA
Disclaimer
Portions of this document have been determined to be exempt
from disclosure under the Freedom of Information Act (the
FOIA) (5 U.S.C. §552). These redacted portions will appear
as white space on the screen or on the printed page.
FDA Briefing Document, FDA Statistical Review and Evaluation; Rotarix, Live Attenuated Human Rotavirus (HRV) Vaccine, Oral (GSK) (html)
FDA Briefing Document, Rotarix (rotavirus vaccine, live, oral) (html)
Errata FDA Briefing Document, Rotarix (rotavirus vaccine,
live, oral) (doc) (html)