Package Inserts & EUAs
FDA’s Center for Biologics Evaluation and ResearchĀ 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 useĀ the filter to choose a specific vaccine.
Manufacturer’s contact information
Results (79)
Rabies: RabAvert Package Insert
Bavarian Nordic
Rotavirus: RotaTeq Package Insert
Merck & Co., Inc.
Rotavirus: Rotarix Package Insert
GSK
Smallpox & Mpox: ACAM2000 Package Insert
Emergent Biosolutions
Smallpox & Mpox: Emergency Use Authorization (EUA) Information
Jynneos
Smallpox & Mpox: Jynneos Package Insert
Bavarian Nordic A/S
Tdap: Adacel Package Insert
Sanofi U.S.
Tdap: Boostrix Package Insert
GSK
Tick-borne encephalitis: Ticovac Package Insert
Pfizer
Typhoid: Typhim Vi Package Insert
Sanofi U.S.
Typhoid: Vivotif Package Insert
Bavarian Nordic A/S
Varicella (chickenpox): Varivax Package Insert
Merck & Co., Inc.
Yellow Fever: YF-Vax Package Insert
Sanofi U.S.
Zoster (shingles): Shingrix Package Insert
GSK