Package Inserts & EUAs
FDA’s Center for Biologics Evaluation and Research regulates biological products, including vaccines, for human use. As part of their responsibility to ensure that these products are safe and effective, they also approve product labeling, package inserts, and issue emergency use authorizations (EUAs).
Here we provide package inserts, product approvals, EUAs, and other supporting documents listed alphabetically by vaccine. You may use the filter to choose a specific vaccine.
Manufacturer’s contact information
Results (7)
Combination Vaccine (DTaP-HepB-IPV): Pediarix Package Insert
GSK
Combination Vaccine (DTaP-IPV): Kinrix Package Insert
GSK
Combination Vaccine (DTaP-IPV): Quadracel Package Insert
Sanofi U.S.
Combination Vaccine (DTaP-IPV-Hib-HepB): Vaxelis Package Insert
MSP Vaccine Company
Combination Vaccine (DTaP-IPV/Hib): Pentacel Package Insert
Sanofi U.S.
Tdap: Adacel Package Insert
Sanofi U.S.
Tdap: Boostrix Package Insert
GSK