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 (5)
RSV: Abrysvo Package Insert
Pfizer
RSV: Arexvy Package Insert
GSK
RSV: Beyfortus Package Insert
Sanofi
RSV: Enflonsia Package Insert
Merck
RSV: Mresvia Package Insert
Moderna