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.

Ireland - English - HPRA (Health Products Regulatory Authority)

glaxosmithkline (ireland) limited - a/california/7/2009 (h1n1) pdm09-like strain used nib-74xp derived from a/christchurch/16/2010, a/hong kong/4801/2014 (h3n2) - like strain (a/hong kong/4801/2014, nymc x-263b), b/brisbane/60/2008 - like strain (b/brisbane/60/2008) - suspension for injection - 15/15/15mc microgram - influenza vaccines

Malta - English - Medicines Authority

smithkline beecham limited 980, great west road, brentford middlesex tw8 9gs, united kingdom - a, california, h, b, brisbane, victoria lineage, like strain, medi - suspension for injection - a/california/7/2009 (h1n1) 15 µg b/brisbane/60/2008 (victoria lineage)-like strain (b/brisbane/60/2008, medi 228030) 15 µg - vaccines

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

glaxosmithkline pharmaceutical sdn. bhd. - influenza split virus, inactivated -

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

seqirus pty ltd - influenza virus haemagglutinin, quantity: 15 microgram - injection, suspension - excipient ingredients: sodium chloride; dibasic sodium phosphate; monobasic sodium phosphate; potassium chloride; monobasic potassium phosphate; calcium chloride dihydrate; water for injections - for the prevention of influenza caused by influenza virus, types a and b contained in the vaccine. the vaccine is indicated for use only in persons aged 5 years and over. for full details regarding recommendations for influenza vaccination, please refer to the relevant national immunisation guidelines.

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

seqirus pty ltd - influenza virus haemagglutinin, quantity: 15 microgram - injection, suspension - excipient ingredients: sodium chloride; dibasic sodium phosphate; monobasic sodium phosphate; potassium chloride; monobasic potassium phosphate; calcium chloride dihydrate; water for injections - for the prevention of influenza caused by influenza virus, types a and b contained in the vaccine. the vaccine is indicated for use only in persons aged 5 years and over. for full details regarding recommendations for influenza vaccination, please refer to the relevant national immunisation guidelines.

Singapore - English - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - influenza virus (nh) a/california/7/2009 (h1n1)pdm09 - like strain - injection - 15 mcg haemagglutinin/0.5 ml

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

glaxosmithkline biologicals sa - influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (formaldehyde inactivated) (unii: au5c98u4bb) (influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) hemagglutinin antigen (formaldehyde inactivated) - unii:c46xjt9fq9), influenza a virus a/darwin/6/2021 ivr-227 (h3n2) antigen (formaldehyde inactivated) (unii: f5qv7af326) (influenza a virus a/darwin/6/2021 ivr-227 (h3n2) hemagglutinin antigen (formaldehyde inactivated) - unii:n969qk7xd2), influenza b virus b/austria/1359417/2021 bvr-26 antigen - influenza a virus a/singapore/gp1908/2015 ivr-180 (h1n1) hemagglutinin antigen (formaldehyde inactivated) 15 ug in 0.5 ml - fluarix quadrivalent is indicated for active immunization for the prevention of disease caused by influenza a subtype viruses and type b viruses contained in the vaccine [see description (11)] . fluarix quadrivalent is approved for use in persons aged 6 months and older. do not administer fluarix quadrivalent to anyone with a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or following a previous administration of any influenza vaccine [see description (11)] . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. available data from a pregnancy registry do not suggest an increased risk of major birth defects and miscarriage in individuals who received fluarix quadrivalent within 28 days prior to conception or during pregnancy (see d

New Zealand - English - Medsafe (Medicines Safety Authority)

seqirus (nz) ltd - influenza virus a (h1n1) haemagglutinin 15ug (a/victoria/4897/2022 (h1n1)pdm09-like virus (a/victoria/4897/2022 (ivr-238))); influenza virus a (h3n2) haemagglutinin 15ug (a/thailand/8/2022 (h3n2)-like virus (a/thailand/8/2022 (ivr-237))); influenza virus b (victoria) haemagglutinin 15ug (b/austria/1359417/2021(b/victoria lineage)-like virus (b/austria/1359417/2021 (bvr-26))); influenza virus b (yamagata) haemagglutinin 15ug (b/phuket/3073/2013-like virus (b/phuket/3073/2013 (bvr-1b))) - suspension for injection - 60 mcg/0.5ml - active: influenza virus a (h1n1) haemagglutinin 15ug (a/victoria/4897/2022 (h1n1)pdm09-like virus (a/victoria/4897/2022 (ivr-238))) influenza virus a (h3n2) haemagglutinin 15ug (a/thailand/8/2022 (h3n2)-like virus (a/thailand/8/2022 (ivr-237))) influenza virus b (victoria) haemagglutinin 15ug (b/austria/1359417/2021(b/victoria lineage)-like virus (b/austria/1359417/2021 (bvr-26))) influenza virus b (yamagata) haemagglutinin 15ug (b/phuket/3073/2013-like virus (b/phuket/3073/2013 (bvr-1b))) excipient: calcium chloride dihydrate dibasic sodium phosphate monobasic potassium phosphate monobasic sodium phosphate potassium chloride sodium chloride water for injection - for the prevention of influenza caused by influenza virus, types a and b contained in the vaccine. afluria quad vaccine is indicated for use in persons aged 3 years and over. for full details regarding recommendations for influenza vaccination, please refer to the relevant national immunisation guidelines.