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
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.
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M. Carolyn Hardegree, M.D.
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research