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Vaccines, Blood & Biologics

July 7, 1998 Approval Letter - Engerix-B

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

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