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These highlights do not include all the information needed to use AREPANRIX safely and effectively. See full prescribing information for AREPANRIX. AREPANRIX (Influenza A [H5] Monovalent Vaccine, Adjuvanted) injectable emulsion, for intramuscular useInitial U.S. Approval: 2013
Medication labelWhy this: Advisory · dailymed-other
AREPANRIX is indicated for active immunization for the prevention of disease caused by the influenza A virus H5 subtype contained in the vaccine. AREPANRIX is approved for use in individuals 6 months of age and older at increased risk of exposure to the influenza A virus H5 subtype contained in the vaccine. In individuals 6 months through 17 years of age, this indication is approved under accelerated approval based on immune responses, as measured by hemagglutination‑inhibition (HI) titers [see Clinical Studies ( 14.2 )]. Continued approval for this indication in individuals 6 months through 17 years of age may be contingent upon verification and description of clinical benefit in a confirmatory trial.
- generic_name
- influenza a h5 monovalent vaccine
- brand_name
- Influenza A Virus A/Astrakhan/3212/2020Idcdc-Rg71a (H5n8) Antigen (UV, Formaldehyde Inactivated), AS03
- product_names
- Influenza A H5 Monovalent Vaccine, Influenza A Virus A/Astrakhan/3212/2020Idcdc-Rg71a (H5n8) Antigen (UV, Formaldehyde Inactivated), AS03
- ndc
- 58160-742, 58160-742-25, 58160-753, 58160-753-01, 58160-753-19, 58160-855, 58160-855-01, 58160-855-19
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en