Vaccines, Blood & Biologics
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4/1/2008 Telecon - Rotarix
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
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.