European Union - English - EMA (European Medicines Agency)

ology bioservices ireland ltd - influenza virus (whole virion, inactivated), containing antigen of: a/vietnam/1203/2004 (h5n1) - influenza, human; immunization; disease outbreaks - influenza vaccines - active immunisation against h5n1 subtype of influenza a virus. this indication is based on immunogenicity data from subjects from the age of 6 months onwards following administration of two doses of vaccine prepared with h5n1 subtype strains. vepacel should be used in accordance with official guidance.,

Israel - English - Ministry of Health

abbott medical laboratories ltd, israel - 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; a/darwin/9/2021 (h3n2)-like virus 30 mcg ha / 1 ml; b/austria/1359417/2021 (b/victoria lineage)-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 - prophylaxis of influenza, especially those who run an increased risk of associated complications. influvac tetra is indicated in adults and children from 6 months of age.

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.

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/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.

European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - split influenza virus inactivated, containing antigen equivalent to a/california/07/2009 (h1n1)-derived strain used nymc x-179a - influenza, human; immunization; disease outbreaks - influenza vaccines - prophylaxis of influenza caused by a (h1n1)v 2009 virus. pandemrix should only be used if the recommended annual seasonal trivalent / quadrivalent influenza vaccines are not available and if immunisation against (h1n1)v is considered necessary (see sections 4.4 and 4.8).pandemrix should be used in accordance with official guidance.

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

glaxosmithkline australia pty ltd - influenza virus haemagglutinin -

Ireland - English - HPRA (Health Products Regulatory Authority)

seqirus s.r.l. - a/michigan/45/2015 (h1n1) pdm09 - like strain (a/singapore/gp1908/2015, ivr-180a); a/singapore/imfimh-16-0019/2016 (h3n2)-like strain (a/singapore/infimh-16-0019/2016,nib-104); b/colorado/06/2017-like strain (b/victoria/2/87 lineage)(b/maryland/15/2016,nymc bx-69a) - suspension for injection in pre-filled syringe - 0.5 millilitre(s) - influenza vaccines; influenza, inactivated, split virus or surface antigen - influenza vaccine - active immunisation against influenza in the elderly (65 years of age and over. refer to spc for detailed information.

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 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 persons 65 years of age and older.

Malta - English - Medicines Authority

mylan ire healthcare limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - influenza vaccine, split virion, inactivated - suspension for injection in pre-filled syringe - influenza vaccine (split virion, inactivated) 15 µg - vaccines