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.

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)

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

Ireland - English - HPRA (Health Products Regulatory Authority)

mylan products limited - a/michigan/45/2015 (h1n1) pdm09 - like strain (a/singapore/gp1908/2015, ivr-180a), a/hong kong/4801/2014 (h3n2) - like strain (a/hong kong/4801/2014, nymc x-263b), b/phuket/3073/2013 -like strain (b/phuket/3073/2013, wild type), b/brisbane/60/2008 - like strain (b/brisbane/60/2008) - solution for injection in pre-filled syringe - 15 microgram - influenza vaccines

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - influenza virus a (h1n1) haemagglutinin 15ug (a/victoria/4897/2022 (h1n1) pdm09-like strain (a/victoria/4897/2022, ivr-238)); influenza virus a (h3n2) haemagglutinin 15ug (a/thailand/8/2022 (h3n2)-like strain (a/thailand/8/2022, ivr-237)); influenza virus b (victoria) haemagglutinin 15ug (b/austria/1359417/2021-like strain (b/austria/1359417/2021, bvr-26)); influenza virus b (yamagata) haemagglutinin 15ug (b/phuket/3073/2013-like strain (b/phuket/3073/2013, wild type)) - suspension for injection - 0.5 ml - active: influenza virus a (h1n1) haemagglutinin 15ug (a/victoria/4897/2022 (h1n1) pdm09-like strain (a/victoria/4897/2022, ivr-238)) influenza virus a (h3n2) haemagglutinin 15ug (a/thailand/8/2022 (h3n2)-like strain (a/thailand/8/2022, ivr-237)) influenza virus b (victoria) haemagglutinin 15ug (b/austria/1359417/2021-like strain (b/austria/1359417/2021, bvr-26)) influenza virus b (yamagata) haemagglutinin 15ug (b/phuket/3073/2013-like strain (b/phuket/3073/2013, wild type)) excipient: calcium chloride dihydrate dibasic sodium phosphate as dihydrate 0.67 mg magnesium chloride hexahydrate monobasic potassium phosphate potassium chloride sodium chloride water for injection - for the prevention of influenza caused by influenza virus, types a and b. for full details regarding recommendations for influenza vaccination, please refer to the relevant national immunisation guidelines. influvac tetra is indicated in adults and children from 6 months of age and older.

New Zealand - English - Medsafe (Medicines Safety Authority)

seqirus (nz) ltd - 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 (x-311)); influenza virus b/phuket/3073/2013 - like strain 15ug ( b/phuket/3073/2013 (bvr-1b)) - suspension for injection - 45 mcg/0.5ml - 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 (x-311)) influenza virus b/phuket/3073/2013 - like strain 15ug ( b/phuket/3073/2013 (bvr-1b)) excipient: calcium chloride dihydrate citric acid monohydrate dibasic sodium phosphate dihydrate magnesium chloride hexahydrate monobasic potassium phosphate polysorbate 80 potassium chloride sodium chloride sodium citrate dihydrate sorbitan trioleate squalene water for injection - active immunisation against influenza in the elderly (65 years of age and older), especially for those with an increased risk of associated complications (i.e. patients affected by underlying chronic diseases including diabetes, cardiovascular and respiratory diseases). the use of fluad should be based on official recommendations.

Israel - English - Ministry of Health

glaxo smith kline (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 - suspension for injection - b/phuket/3073/2013 (b/yamagata lineage)-like virus 30 mcg ha / 1 ml; b/austria/1359417/2021 (b/victoria lineage)-like virus 30 mcg ha / 1 ml; a/darwin/9/2021 (h3n2)-like virus 30 mcg ha / 1 ml; a/victoria/4897/2022 (h1n1)pdm09-like virus 30 mcg ha / 1 ml - influenza, inactivated, split virus or surface antigen - fluarix tetra is indicated for active immunisation of adults and children from 6 months of age for the prevention of influenza disease caused by the two influenza a virus subtypes and the two influenza b virus types contained in the vaccine.

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

glaxosmithkline uk ltd - influenza virus split virion - suspension for injection

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

seqirus pty ltd - influenza virus haemagglutinin, quantity: 30 microgram/ml - injection, suspension - excipient ingredients: sodium chloride; potassium chloride; monobasic potassium phosphate; dibasic sodium phosphate dihydrate; magnesium chloride hexahydrate; calcium chloride dihydrate; squalene; polysorbate 80; sorbitan trioleate; sodium citrate dihydrate; citric acid monohydrate; water for injections - active immunisation against influenza in the elderly (65 years of age and older), especially for those with an increased risk of associated complications (i.e. patients affected by underlying chronic diseases including diabetes, cardiovascular and respiratory diseases).

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

seqirus pty ltd - influenza virus haemagglutinin, quantity: 30 microgram/ml - injection, suspension - excipient ingredients: sodium chloride; potassium chloride; monobasic potassium phosphate; dibasic sodium phosphate dihydrate; magnesium chloride hexahydrate; calcium chloride dihydrate; squalene; polysorbate 80; sorbitan trioleate; sodium citrate dihydrate; citric acid monohydrate; water for injections - active immunisation against influenza in the elderly (65 years of age and older), especially for those with an increased risk of associated complications (i.e. patients affected by underlying chronic diseases including diabetes, cardiovascular and respiratory diseases).