New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - influenza virus a/michigan/45/2015 (h1n1) pdm09 - like strain 15ug (a/singapore/gp1908/2015, ivr-180); influenza virus a/singapore/infimh-16-0019/2016 (h3n2) - like strain 15ug (a/singapore/infimh-16-0019/2016, nib-104); influenza virus b/phuket/3073/2013 - like strain 15ug (b/phuket/3073/2013, wild type) - suspension for injection - 0.5 ml - active: influenza virus a/michigan/45/2015 (h1n1) pdm09 - like strain 15ug (a/singapore/gp1908/2015, ivr-180) influenza virus a/singapore/infimh-16-0019/2016 (h3n2) - like strain 15ug (a/singapore/infimh-16-0019/2016, nib-104) influenza virus b/phuket/3073/2013 - like strain 15ug (b/phuket/3073/2013, wild type) excipient: calcium chloride dihydrate dibasic sodium phosphate dihydrate magnesium chloride hexahydrate monobasic potassium phosphate potassium chloride sodium chloride water for injection - for the prevention of influenza virus, types a and b in adults and children older than 6 months in accordance with the recommendations in the national immunisation guideline.

New Zealand - English - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - influenza virus a/california/7/2009 (h1n1) - like strain 9ug (a/california/7/2009 nymc x-179a); influenza virus a/texas/50/2012 (h3n2) like strain 9ug (a/texas/50/2012 nymc x-223a); influenza virus b/massachusetts/2/2012 like strain 9ug (wild type) - suspension for injection - 9 mcg - active: influenza virus a/california/7/2009 (h1n1) - like strain 9ug (a/california/7/2009 nymc x-179a) influenza virus a/texas/50/2012 (h3n2) like strain 9ug (a/texas/50/2012 nymc x-223a) influenza virus b/massachusetts/2/2012 like strain 9ug (wild type) excipient: dibasic sodium phosphate dihydrate hydrochloric acid monobasic potassium phosphate potassium chloride sodium chloride sodium hydroxide water for injection - intanza 9mcg is indicated for prophylaxis of influenza in adults from 18 to 59 years of age. the use of intanza 9mcg in new zealand should be based on the ministry of health recommendations for influenza vaccination as published in the current new zealand immunisation handbook.

Israel - English - Ministry of Health

astrazeneca (israel) ltd - a/darwin/9/2021 (h3n2)-like virus; a/victoria/4897/2022 (h1n1)pdm09-like virus; b/austria/1359417/2021 (b/victoria lineage)-like virus; b/phuket/3073/2013 (b/yamagata lineage)-like virus - nasal spray, suspension - b/phuket/3073/2013 (b/yamagata lineage)-like virus 7 ±0.5 log10 ffu^a / 0.2 ml; a/darwin/9/2021 (h3n2)-like virus 7 ±0.5 log10 ffu^a / 0.2 ml; b/austria/1359417/2021 (b/victoria lineage)-like virus 7 ±0.5 log10 ffu^a / 0.2 ml; a/victoria/4897/2022 (h1n1)pdm09-like virus 7 ±0.5 log10 ffu^a / 0.2 ml - influenza, inactivated, split virus or surface antigen - influenza, purified antigen - flumist quadrivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza a subtype viruses ad type b viruses contained in the vaccine. flumist quadrivalent is approved for use in persons 2 through 49 years of age.

European Union - English - EMA (European Medicines Agency)

sanofi pasteur s.a. - split influenza virus, inactivated, containing antigen*: a/california/7/2009 (h1n1)v like strain (x-179a)*propagated 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - influenza virus a/michigan/45/2015 (h1n1) pdm09 - like strain 15ug (a/singapore/gp1908/2015, ivr-180); influenza virus a/switzerland/8060/2017 (h3n2) like strain 15ug (a/brisbane/1/2018, nymc x-311); influenza virus b/colorado/06/2017 - like strain 15ug (b/maryland/15/2016, nymc bx-69a (victoria lineage)); influenza virus b/phuket/3073/2013 - like strain 15ug (b/phuket/3073/2013, wild type (yamagata lineage)) - suspension for injection - 0.5 ml - active: influenza virus a/michigan/45/2015 (h1n1) pdm09 - like strain 15ug (a/singapore/gp1908/2015, ivr-180) influenza virus a/switzerland/8060/2017 (h3n2) like strain 15ug (a/brisbane/1/2018, nymc x-311) influenza virus b/colorado/06/2017 - like strain 15ug (b/maryland/15/2016, nymc bx-69a (victoria lineage)) influenza virus b/phuket/3073/2013 - like strain 15ug (b/phuket/3073/2013, wild type (yamagata lineage)) excipient: d-alpha-tocopheryl acid succinate dibasic sodium phosphate dodecahydrate magnesium chloride hexahydrate monobasic potassium phosphate octoxinol polysorbate 80 potassium chloride sodium chloride water for injection - fluarix tetra is a quadrivalent vaccine indicated for active immunisation of adults and children from 6 months of age for the prevention of influenza disease caused by the influenza virus types a and b contained in the vaccine. the use of fluarix tetra should be based on official recommendations.

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

novartis vaccines and diagnostics limited - influenza a virus a/california/7/2009 x-181 (h1n1) antigen (formaldehyde inactivated) (unii: 872508x6jg) (influenza a virus a/california/7/2009 x-181 (h1n1) hemagglutinin antigen (formaldehyde inactivated) - unii:5cl7878s2q) - influenza a virus a/california/7/2009 x-181 (h1n1) antigen (formaldehyde inactivated) 15 ug in 0.5 ml

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

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

biocsl pty ltd. - influenza a virus a/california/7/2009 x-181 (h1n1) antigen (propiolactone inactivated) (unii: bh0r06yxfz) (influenza a virus a/california/7/2009 x-181 (h1n1) hemagglutinin antigen (propiolactone inactivated) - unii:mhg4xw7big), influenza a virus a/south australia/55/2014 ivr-175 (h3n2) antigen (propiolactone inactivated) (unii: 5087bpo79o) (influenza a virus a/south australia/55/2014 ivr-175 (h3n2) hemagglutinin antigen (propiolactone inactivated) - unii:9a68j3t9te), influenza b virus b/phuket/3073/2013 ant - influenza a virus a/california/7/2009 x-181 (h1n1) hemagglutinin antigen (propiolactone inactivated) 15 ug in 0.5 ml - afluria® is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes a and type b present in the vaccine. afluria is approved for use in persons 5 years of age and older. afluria is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine (see description [11]) . pregnancy category b: a reproductive and developmental toxicity study has been performed in female rats at a dose approximately 265 times the human dose (on a mg/kg basis) and revealed no evidence of impaired female fertility or harm to the fetus due to afluria. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, afluria should be given to a pregnant woman only if clearly needed. in the reproductive and developmental toxicity study, the effect

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

sanofi pasteur inc. - influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) antigen (formaldehyde inactivated) (unii: wd5e5vym2e) (influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) hemagglutinin antigen (formaldehyde inactivated) - unii:erb9sj9vmq), influenza a virus a/darwin/9/2021 san-010 (h3n2) antigen (formaldehyde inactivated) (unii: kja387fhb2) (influenza a virus a/darwin/9/2021 san-010 (h3n2) hemagglutinin antigen (formaldehyde inactivated) - unii:6s4y8a8uey), influenza b virus b/phuket/3073/2013 antigen (formaldehy - influenza a virus a/michigan/45/2015 x-275 (h1n1) hemagglutinin antigen (formaldehyde inactivated) 15 ug in 0.5 ml - fluzone® quadrivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza a subtype viruses and type b viruses contained in the vaccine. fluzone quadrivalent is approved for use in persons 6 months of age and older. do not administer fluzone quadrivalent to anyone with a history of 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. pregnancy exposure registry sanofi pasteur inc. is maintaining a prospective pregnancy exposure registry to collect data on pregnancy outcomes following vaccination with fluzone quadrivalent during pregnancy. healthcare providers are encouraged to enroll women who receive fluzone quadrivalent during pregnancy in sanofi pasteur inc.'s vaccination pregnancy registry by calling 1-800-822-2463. risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general popul

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

h1n1 - suspension for injection