Ireland - English - HPRA (Health Products Regulatory Authority)

viatris healthcare limited - a/victoria/2570/2019 (h1n1)pdm09 - like strain (a/victoria/2570/2019, ivr-215) ; a/darwin/9/2021 (h3n2) - like strain (a/darwin/9/2021, ivr-228); b/phuket/3073/2013 -like strain (b/phuket/3073/2013, wild type); b/austria/1359417/2021 - like strain (b/michigan/01/2021, wild type) - suspension for injection in pre-filled syringe - influenza vaccines; influenza, inactivated, split virus or surface antigen

European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - whole virion, inactivated, containing antigen*: a/vietnam/1194/2004 (h5n1)* produced in eggs - influenza, human; immunization; disease outbreaks - vaccines - prophylaxis of influenza in an officially declared pandemic situation. pandemic influenza vaccine should be used in accordance with official guidance.

United States - English - NLM (National Library of Medicine)

sanofi pasteur inc. - influenza a virus a/brisbane/02/2018 ivr-190 (h1n1) antigen (formaldehyde inactivated) (unii: xw4jb03ti5) (influenza a virus a/brisbane/02/2018 ivr-190 (h1n1) hemagglutinin antigen (formaldehyde inactivated) - unii:92xe6ghc89), influenza a virus a/kansas/14/2017 x-327 (h3n2) antigen (formaldehyde inactivated) (unii: 3nzw5nd3d6) (influenza a virus a/kansas/14/2017 x-327 (h3n2) hemagglutinin antigen (formaldehyde inactivated) - unii:k329ycd1n9), influenza b virus b/maryland/15/2016 bx-69a antigen (formaldeh - influenza a virus a/michigan/45/2015 x-275 (h1n1) hemagglutinin antigen (formaldehyde inactivated) 60 ug in 0.5 ml - fluzone® high-dose is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza a subtype viruses and type b virus contained in the vaccine. fluzone high-dose is approved for use in persons 65 years of age and older. a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine [see description (11) ], including egg protein, or to a previous dose of any influenza vaccine is a contraindication to administration of fluzone high-dose. fluzone high-dose is not approved for use in persons <65 years of age. there are limited human data and no animal data available to establish whether there is a vaccine-associated risk with use of fluzone high-dose in pregnancy. fluzone high-dose is not approved for use in persons <65 years of age. no human or animal data are available to assess the effects of fluzone high-dose on the breastfed infant or on milk production/excretion. safety and effectiveness of fluzone high-dose in persons <65 years of age have not bee

New Zealand - English - Medsafe (Medicines Safety Authority)

seqirus (nz) ltd - influenza virus a/hong kong/4801/2014 (h3n2) - like strain 15ug (a/hong kong/4801/2014 (x-263b)); influenza virus a/michigan/45/2015 (h1n1) pdm09 - like strain 15ug (a/singapore/gp1908/2015 (ivr-180)); influenza virus b/brisbane/60/2008 - like strain 15ug (b/brisbane/46/2015) - suspension for injection - 0.5 ml - active: influenza virus a/hong kong/4801/2014 (h3n2) - like strain 15ug (a/hong kong/4801/2014 (x-263b)) influenza virus a/michigan/45/2015 (h1n1) pdm09 - like strain 15ug (a/singapore/gp1908/2015 (ivr-180)) influenza virus b/brisbane/60/2008 - like strain 15ug (b/brisbane/46/2015) excipient: calcium chloride dihydrate dibasic sodium phosphate monobasic potassium phosphate monobasic sodium phosphate dihydrate potassium chloride sodium chloride water for injection - fluvax is indicated for the prevention of influenza caused by infuenza virus, types a and b. for the southern hemisphere 2017 season, the vaccine is indicated for use only in persons aged 5 years and over

New Zealand - English - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - influenza virus a/hong kong/4801/2014 (h3n2) - like strain 15ug (a/ hong kong/4801/2014 nymc x-263b );  ; influenza virus a/michigan/45/2015 (h1n1) pdm09 - like strain 15ug (a/michigan/45/2015 nymc x-275);  ; influenza virus b/brisbane/60/2008 - like strain 15ug (b/brisbane/60/2008 );   - solution for injection - 0.5 ml - active: influenza virus a/hong kong/4801/2014 (h3n2) - like strain 15ug (a/ hong kong/4801/2014 nymc x-263b )   influenza virus a/michigan/45/2015 (h1n1) pdm09 - like strain 15ug (a/michigan/45/2015 nymc x-275)   influenza virus b/brisbane/60/2008 - like strain 15ug (b/brisbane/60/2008 )   excipient: dibasic sodium phosphate dihydrate monobasic potassium phosphate neomycin potassium chloride sodium chloride water for injection - vaxigrip is indicated for the prevention of influenza caused by influenza virus types a and b in adults and children aged 6 months and over.

Australia - English - Department of Health (Therapeutic Goods Administration)

seqirus pty ltd - influenza virus haemagglutinin, quantity: 30 microgram/ml - injection, suspension - excipient ingredients: monobasic potassium phosphate; water for injections; thiomersal; calcium chloride dihydrate; dibasic sodium phosphate; potassium chloride; sodium chloride; monobasic sodium phosphate - for active immunization against influenza disease caused by influenza subtype viruses and type b viruses contained in the vaccine.

Australia - English - Department of Health (Therapeutic Goods Administration)

seqirus pty ltd - influenza virus haemagglutinin, quantity: 30 microgram/ml - injection, suspension - excipient ingredients: dibasic sodium phosphate; water for injections; monobasic potassium phosphate; sodium chloride; potassium chloride; calcium chloride dihydrate; monobasic sodium phosphate - for active immunization against influenza disease caused by influenza a subtype viruses and type b viruses contained in the vaccine.

United States - English - NLM (National Library of Medicine)

newton laboratories, inc. - influenza a virus (unii: r9hh0nde2e) (influenza a virus - unii:r9hh0nde2e), influenza b virus (unii: 1314jz2x6w) (influenza b virus - unii:1314jz2x6w), histamine dihydrochloride (unii: 3poa0q644u) (histamine - unii:820484n8i3), aconitum napellus (unii: u0nq8555jd) (aconitum napellus - unii:u0nq8555jd), american ginseng (unii: 8w75vcv53q) (american ginseng - unii:8w75vcv53q), arsenic trioxide (unii: s7v92p67ho) (arsenic cation (3+) - unii:c96613f5av), baptisia tinctoria root (unii: 5ef0hwi5wu) (baptisia tinc - influenza a virus 35 [hp_x] in 1 ml - influenza   formulated for symptoms associated with colds and flu such as aches, discomfort, fatigue, respiratory dysfunction and digestive upset.

United States - English - NLM (National Library of Medicine)

newton laboratories, inc. - influenza a virus (unii: r9hh0nde2e) (influenza a virus - unii:r9hh0nde2e), influenza b virus (unii: 1314jz2x6w) (influenza b virus - unii:1314jz2x6w), histamine dihydrochloride (unii: 3poa0q644u) (histamine - unii:820484n8i3), aconitum napellus (unii: u0nq8555jd) (aconitum napellus - unii:u0nq8555jd), american ginseng (unii: 8w75vcv53q) (american ginseng - unii:8w75vcv53q), arsenic trioxide (unii: s7v92p67ho) (arsenic cation (3+) - unii:c96613f5av), baptisia tinctoria root (unii: 5ef0hwi5wu) (baptisia tinc - influenza a virus 35 [hp_x] in 1 g - influenza   formulated for symptoms associated with colds and flu such as aches, discomfort, fatigue, respiratory dysfunction and digestive upset.

Australia - English - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - influenza virus haemagglutinin, quantity: 3.75 microgram - injection, suspension - excipient ingredients: water for injections; polysorbate 80; magnesium chloride hexahydrate; sodium chloride; thiomersal; potassium chloride; dibasic sodium phosphate dodecahydrate; octoxinol 10; monobasic potassium phosphate - prophylaxis of influenza in an officially declared pandemic situation. pandemrix h5n1 should be used in accordance with official recommendations.