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DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Food and Drug Administration 1401 Rockville Pike Rockville, MD 20852-1448 July 7, 1998 Our Reference Number: 97-0816 Johan Van Hoof, Ph.D. SmithKline Beecham Biologicals 89, rue de l'Institut 1330 Rixensart Belgium Dear Dr. Van Hoof: The Supplement to your Product License Application for Hepatitis B Vaccine, (Recombinant) to include the use of Hepatitis B Vaccine, (Recombinant) in individuals with chronic hepatitis C infection, has been approved. This information will be included in your Product License Application file. Sincerely yours,  --- signature --- M. Carolyn Hardegree, M.D. Director Office of Vaccines Research and Review Center for Biologics Evaluation and Research

Updated January 23, 2001

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