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.

Ireland - English - HPRA (Health Products Regulatory Authority)

glaxosmithkline (ireland) limited - a/victoria/4897/2022 (h1n1)pdm09-like strain (a/victoria/4897/2022, ivr-238; a/darwin/9/2021 (h3n2)-like strain (a/darwin/6/2021, ivr-227); b/austria/1359417/2021 - like strain (b/austria/1359417/2021, bvr-26) [victoria lineage]; b/phuket/3073/2013 -like strain (b/phuket/3073/2013, wild type) - suspension for injection in pre-filled syringe - 15 international unit(s) - influenza vaccines; influenza, inactivated, split virus or surface antigen

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.

Singapore - English - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - influenza virus (sh) a/thailand/8/2022 (h3n2) - like strain; influenza virus (sh) a/victoria/4897/2022 (h1n1)pdm09-like strain; influenza virus (sh) b/austria/1359417/2021 - like strain; influenza virus (sh) b/phuket/3073/2013-like strain - injection, suspension - influenza virus (sh) a/thailand/8/2022 (h3n2) - like strain 15mcg ha/0.5ml; influenza virus (sh) a/victoria/4897/2022 (h1n1)pdm09-like strain 15mcg ha/0.5ml; influenza virus (sh) b/austria/1359417/2021 - like strain 15mcg ha/0.5ml; influenza virus (sh) b/phuket/3073/2013-like strain 15mcg ha/0.5ml

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - influenza virus a/california/7/2009 (h1n1) - like strain 30 µg/ml (a/christchurch/16/2010 (nib-74xp) (15 µg ha)); influenza virus a/hong kong/4801/2014 (h3n2) - like strain 30 µg/ml (a/hong kong/4801/2014, nymc x-263b (15 µg ha)); influenza virus b/brisbane/60/2008 - like strain 30 µg/ml (b/brisbane/60/2008 (15 µg ha)) - suspension for injection - active: influenza virus a/california/7/2009 (h1n1) - like strain 30 µg/ml (a/christchurch/16/2010 (nib-74xp) (15 µg ha)) influenza virus a/hong kong/4801/2014 (h3n2) - like strain 30 µg/ml (a/hong kong/4801/2014, nymc x-263b (15 µg ha)) influenza virus b/brisbane/60/2008 - like strain 30 µg/ml (b/brisbane/60/2008 (15 µg ha)) excipient: commercial light duty detergent d-alpha-tocopheryl acid succinate dibasic sodium phosphate dodecahydrate formaldehyde gentamicin sulfate magnesium chloride hexahydrate monobasic potassium phosphate potassium chloride sodium chloride sodium deoxycholate sucrose water for injection - fluarix is indicated for prophylaxis against influenza in adults and children older than six months of age.

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

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

Malta - English - Medicines Authority

glaxosmithkline biologicals s.a. rue de l'institut 89 b-1330 rixensart, belgium - a, brisbane, h, ivr, kansas, nymc x, phuket, wild type, nymc bx - suspension for injection in pre-filled syringe - a/darwin/9/2021 (h3n2) - like strain (a/darwin/6/2021, ivr-227 15 µg b/phuket/3073/2013 - like strain (b/phuket/3073/2013, wild type) 15 µg b/austria/1359417/2021 - like strain (b/austria/1359417/2021 bvr-26 15 µg a/victoria/4897/2022 (h1n1) pdm09 - like strain (a/victoria/4897/2022 ivr-238 15 µg - vaccines

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

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.