Product Approval Information - Licensing Action
Proper name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine
Tradename: Infanrix
Manufacturer: SmithKline Beecham Biologicals, 1330 Rixensart, Belgium, License #1090
Indication for Use: Primary and booster immunization of infants and children except as a fifth dose in children who have previously received four doses of DTaP
Approval Date: 1/29/97
Type of submission: Biologics license application
Approval Letter - (PDF),
(Text)
|