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Product Approval Information - Licensing Action

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Proper name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
Tradename: Infanrix
Manufacturer: GlaxoSmithKline Biologicals, 1330 Rixensart BELGIUM, License #1090
Indication for Use: To include in the indication a fifth dose at 4-6 years of age after 4 prior doses of Infanrix
Approval Date: 7/7/2003
Type of submission: Biologics license application supplement

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Approval Letter - (Text)

Label (PDF)

Clinical Review - (PDF), (Text)

 

Updated November 3, 2003
 
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