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Package Inserts & EUAs
FDA’s Center for Biologics Evaluation and Research regulates biological products, including vaccines, for human use VSports app下载. 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
Adenovirus: Adenovirus Package Insert
Barr Labs Inc.
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Anthrax: BioThrax Package Insert
Emergent BioSolutions
Anthrax: Cyfendus Package Insert (V体育官网)
Emergent BioSolutions
BCG Package Insert (VSports app下载)
Organon Teknica (Merck)
COVID-19: Comirnaty Package Insert
Pfizer-BioNTech
COVID-19: Mnexspike Package Insert
Moderna
COVID-19: Nuvaxovid Package Insert
Novavax, Inc
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COVID-19: Spikevax Package Insert
Moderna
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Chikungunya virus (CHIKV): Chikungunya Vaccine, Live Package Insert
Valneva
Chikungunya virus (CHIKV): Chikungunya Vaccine, Recombinant Vimkunya Package Insert
Bavarian Nordic A/S
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Cholera: Vaxchora Package Insert
Bavarian Nordic A/S
Combination Vaccine (DTaP-HepB-IPV): Pediarix Package Insert
GSK
Combination Vaccine (DTaP-IPV): Kinrix Package Insert
GSK
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Combination Vaccine (DTaP-IPV): Quadracel Package Insert
Sanofi U.S.
Combination Vaccine (DTaP-IPV-Hib-HepB): Vaxelis Package Insert
MSP Vaccine Company
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Combination Vaccine (DTaP-IPV/Hib): Pentacel Package Insert
Sanofi U.S.
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Combination Vaccine (HepA-HepB): Twinrix Package Insert
GSK
Combination Vaccine (MMRV): ProQuad Package Insert
Merck & Co.
DTaP: Daptacel Package Insert (V体育平台登录)
Sanofi U.S.
DTaP: Infanrix Package Insert
GSK
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Dengue: Dengvaxia Package Insert
Sanofi U.S.
Diphtheria & Tetanus: Td (generic) Package Insert
MassBiologics
Diphtheria & Tetanus: Tenivac Package Insert
Sanofi U.S.
Ebola virus disease (EVD): Ervebo Package Insert
Merck & Co, Inc.
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Hepatitis A: Havrix Package Insert
GSK
Hepatitis A: Vaqta Package Insert
Merck & Co., Inc.
Hepatitis B: Engerix-B Package Insert
GSK
Hepatitis B: Heplisav-B Package Insert
Dynavax Technologies
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Hepatitis B: PreHevbrio Package Insert
VBI Vaccines Inc.
Hepatitis B: Recombivax HB Package Insert (VSports)
Merck & Co., Inc.
Hib: ActHIB Package Insert
Sanofi U.S.
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Hib: Hiberix Package Insert
GSK
Hib: PedvaxHIB Package Insert (V体育平台登录)
Merck & Co., Inc.
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Human papillomavirus (HPV): Gardasil 9 Package Insert
Merck & Co., Inc.
Influenza: Afluria Trivalent Package Insert
Seqirus
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Influenza: Arepanrix [Influenza A (H5N1) Monovalent Vaccine, Adjuvanted] Package Insert
ID Biomedical Corporation
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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
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Influenza: Flublok Trivalent Package Insert
Protein Sciences Corporation
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Influenza: Flucelvax Trivalent Package Insert
Seqirus
Influenza: Fluzone High Dose Trivalent Package Insert
Sanofi U.S.
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Influenza: Fluzone Trivalent Package Insert
Sanofi U.S.
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Influenza: Audenz [Influenza A (H5N1) Monovalent Vaccine, Adjuvanted] Package Insert
Seqirus
Japanese encephalitis: IXIARO Package Insert
Valneva
Measles, Mumps, Rubella: MMR II Package Insert
Merck & Co., Inc.
Measles, Mumps, Rubella: Priorix Package Insert
GSK
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Meningococcal ABCWY: Penbraya Package Insert
Pfizer
Meningococcal ABCWY: Penmenvy Package Insert
GSK
Meningococcal ACWY: MenQuadfi Package Insert
Sanofi U.S.
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Meningococcal ACWY: Menveo Package Insert
GSK
Meningococcal B: Bexsero Package Insert
GSK
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Meningococcal B: Trumenba Package Insert
Pfizer
Pneumococcal (PCV): Capvaxive Package Insert
Merck & Co., Inc.
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Pneumococcal (PCV): Prevnar 13 Package Insert
Pfizer
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Pneumococcal (PCV): Prevnar 20 Package Insert
Pfizer
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Pneumococcal (PCV): Vaxneuvance (PCV15) Package Insert
Merck & Co, Inc.
Pneumococcal (PPSV): Pneumovax 23 Package Insert
Merck & Co., Inc.
Polio: IPOL Package Insert
Sanofi U.S.
RSV: Abrysvo Package Insert
Pfizer
RSV: Arexvy Package Insert
GSK
RSV: Beyfortus Package Insert
Sanofi
RSV: Enflonsia Package Insert
Merck
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RSV: Mresvia Package Insert
Moderna
This page was updated on August 26, 2025. VSports手机版.