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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

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4/1/2008 Telecon - Rotarix

TELECON

DATE: April 1, 2008

CBER participants: Laraine Henchal, Jingyee Kou, Dale Horne, Lew Schrager, Douglas Pratt, Norman Baylor, Steve Rosenthal, Florence Houn, Luba Vujcic

GSK participants: Len Friedland, Tracey Lee, Benedicte T. Dupasquier, Brigette Chevart, Barbara Howe, Claire Khan, Michael Van der Wert, Donna Boyce

11AM
CBER and GSK discussed and finalized the indication for Rotarix. It was agreed to make the indication for prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in infants and children. It was also agreed that the dating period for the product would be 24 months.

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448
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