Package Inserts & EUAs
FDA’s Center for Biologics Evaluation and Research regulates biological products, including vaccines, for human use. As part of their responsibility of ensuring that these products are safe and effective, they also approve product labeling, or package inserts.
Here we provide package inserts, product approvals, and other supporting documents listed alphabetically by vaccine, or use the filter to choose a specific vaccine.
Manufacturer’s contact information
Results (10)
Influenza: Afluria Trivalent Package Insert
Seqirus
Influenza: Arepanrix Package Insert
ID Biomedical Corporation
Influenza: FluLaval Trivalent Package Insert
ID Biomedical Corporation
Influenza: FluMist Trivalent Package Insert
MedImmune, Inc.
Influenza: Fluad Trivalent Package Insert
Seqirus
Influenza: Fluarix Trivalent Package Insert
GSK
Influenza: Flublok Trivalent Package Insert
Protein Sciences Corporation
Influenza: Flucelvax Trivalent Package Insert
Seqirus
Influenza: Fluzone High Dose Trivalent Package Insert
Sanofi U.S.
Influenza: Fluzone Trivalent Package Insert
Sanofi U.S.