INFANRIX
The FDA has updated product approval information for Infanrix, a Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed.
This update affects manufacturers of DTaP vaccines, regulatory personnel managing vaccine licensure, and clinical operations departments involved in pediatric immunization oversight.
The update ensures that the official record for this biologics license remains current. For regulatory professionals, this represents the authoritative source for approved indications and manufacturing specifications for this specific DTaP formulation. While the source does not detail specific changes, such updates typically precede or confirm labeling modifications or manufacturing site changes that must be reflected in global compliance registries.
Regulatory and compliance teams should verify that their internal product dossiers and labeling records align with the most recent FDA approval information for Infanrix. Quality and pharmacovigilance units should ensure all site-specific records reflect this updated reference documentation.
Product approval information for Diphtheria Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed also known as Infanrix.
Open in openFDA / FDA.gov