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Product Approval Information - Licensing Action

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Proper name: Lyme Disease Vaccine (Recombinant OspA)
Tradename: LYMErix
Manufacturer: SmithKline Beecham Biologicals, B-1330 Rixensart, Belgium, License #1090
Indication for Use: For active immunization against Lyme disease in individuals 15-70 years of age
Approval Date: 12/21/98
Type of submission: Biologics license application

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Approval Letter - (PDF),   (Text)

Label - (PDF)

Review Documents -
     Product Review (PDF)
     Clinical Review (6/27/98) (PDF)
     Clinical Review (7/7/98) (PDF)
     Clinical Review (11/1/98) (PDF)
     Clinical Review (11/7/98) (PDF)
     Statistical Review (6/30/98) (PDF)
     Statistical Review (12/18/98) (PDF)

Talk Paper

 

Updated March 5, 2001
 
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