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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

3/31/2008 Telecon - Rotarix

MEMORANDUM

DATE: March 31, 2008
FROM: Laraine S. Henchal, Microbiologist Reviewer, DVRPA, CBER, Review Committee Chair, STN 125265/0
SUBJECT: Telecon with GSK to discuss wording of indication for Rotarix in labeling

The participants discussed a number of options for the labeled indication for Rotarix, and whether language should be specific with types listed or kept general. No decision was made. A discussion with a larger group including CBER management will be required.

CBER participants:

Steve Rosenthal
Paul Kitsutani
Laraine Henchal

GSK particpants:

Donna Boyce
Barbara Howe
Claire Kahn
Leonard Friedland
Benedicte Dupasquier
Tracey Lee

 

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