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Product Approval Information - Licensing Action

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Proper name: Hepatitis B Vaccine (Recombinant)
Tradename: Engerix-B
Manufacturer: SmithKline Beecham Biologicals, 1330 Rixensart, Belgium, License #1090
Manufacturing Change: Preservative-free pediatric monodose presentation
Approval Date: 3/28/2000
Type of submission: Product license application supplement

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Approval Letter - (Text)

 

Updated March 5, 2001
 
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