European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - split influenza virus, inactivated, containing antigen: a/vietnam/1194/2004 (h5n1) like strain used (nibrg-14) - 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.,

Israel - English - Ministry of Health

medici medical ltd, israel - a/michigan/45/2015 (h1n1)pdm09-like virus; a/singapore/infimh-16-0019/2016 (h3n2) - like virus; b/colorado/06/2017- like virus (b/victoria/2/87 lineage); b/phuket/3073/2013 - like virus (b/yamagata/16/88 lineage) - suspension for injection - b/phuket/3073/2013 - like virus (b/yamagata/16/88 lineage) 15 mcg/dose; a/michigan/45/2015 (h1n1)pdm09-like virus 15 mcg/dose; a/singapore/infimh-16-0019/2016 (h3n2) - like virus 15 mcg/dose; b/colorado/06/2017- like virus (b/victoria/2/87 lineage) 15 mcg/dose - influenza, inactivated, whole virus - influenza, inactivated, whole virus - for the prevention of influenza.

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

novartis vaccines and diagnostics ltd - influenza a virus a/california/7/2009(h1n1)-like hemagglutinin antigen (propiolactone inactivated) (unii: k9p8pva2ug) (influenza a virus a/california/7/2009(h1n1)-like hemagglutinin antigen (propiolactone inactivated) - unii:k9p8pva2ug) - influenza a virus a/california/7/2009(h1n1)-like hemagglutinin antigen (propiolactone inactivated) 15 ug in 0.5 ml - influenza a (h1n1) 2009 monovalent vaccine is an inactivated influenza virus vaccine indicated for immunization of persons 4 years of age and older against influenza disease caused by pandemic (h1n1) 2009 virus. influenza a (h1n1) 2009 monovalent vaccine should not be administered to anyone with known systemic hypersensitivity reactions to egg proteins (eggs or egg products), or to any component of influenza a (h1n1) 2009 monovalent vaccine, or who has had a life-threatening reaction to previous influenza vaccinations [see description (11)]. novartis’ influenza a (h1n1) 2009 monovalent vaccine and seasonal trivalent influenza virus vaccine (fluvirin) are manufactured by the same process. available information for fluvirin is provided in this section. pregnancy category c: animal reproduction studies have not been conducted with influenza a (h1n1) 2009 monovalent vaccine or fluvirin. it is also not known whether influenza a (h1n1) 2009 monovalent vaccine or fluvirin can cause fetal harm when administered to

Ireland - English - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - a/california/07/2009 (h1n1) a/perth/16/2009 (h3n2) like strain (a/victoria/210/2009) b/brisbane/60/2008 (b) - suspension for injection - milligram

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

sanofi pasteur inc. - influenza a virus a/california/7/2009(h1n1)-like antigen (formaldehyde inactivated) (unii: 5i5hvc73i8) (influenza a virus a/california/7/2009(h1n1)-like hemagglutinin antigen (formaldehyde inactivated) - unii:euj84un96z) - influenza a virus a/california/7/2009(h1n1)-like hemagglutinin antigen (formaldehyde inactivated) 15 ug in 0.5 ml - influenza a (h1n1) 2009 monovalent vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons 6 months of age and older against influenza disease caused by pandemic (h1n1) 2009 virus. do not administer influenza a (h1n1) 2009 monovalent vaccine to anyone with a known severe hypersensitivity to egg proteins or any component of the vaccine or life-threatening reactions after previous administration of any influenza vaccine. [see warnings and precautions (5) and description (11) ] sanofi pasteur's influenza a (h1n1) 2009 monovalent vaccine and seasonal trivalent influenza virus vaccine (fluzone vaccine) are manufactured by the same process. available information for fluzone vaccine is provided in this section. pregnancy category c: animal reproduction studies have not been conducted with influenza a (h1n1) 2009 monovalent vaccine or fluzone vaccine. it is also not known whether these vaccines can cause fetal harm when administered to a pregnant woman or can affect reproduction

Malta - English - Medicines Authority

sanofi pasteur 14 espace henry vallée , 69007 lyon, france - influenza vaccine, split virion, inactivated - suspension for injection - influenza vaccine (split virion, inactivated) 15 µg - vaccines

European Union - English - EMA (European Medicines Agency)

novartis vaccines and diagnostics s.r.l. - influenza virus surface antigens (haemagglutinin and neuraminidase) of strain a/viet nam/1194/2004 (h5n1) - influenza, human - vaccines - active immunisation against h5n1 subtype of influenza a virus.; this indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing a/vietnam/1194/2004 (h5n1)-like strain.; prepandemic influenza vaccine (h5n1) novartis vaccines and diagnostic should be used in accordance with official recommendations.

Malta - English - Medicines Authority

sanofi pasteur 14 espace henry vallée , 69007 lyon, france - influenza vaccine, split virion, inactivated - suspension for injection in pre-filled syringe - influenza vaccine (split virion, inactivated) a/victoria/4897/2022 (h1n1) pdm09 - like strain (a/victoria/4897/2022 ivr-238 15 µg a/darwin/9/2021 (h3n2) - like strain (a/darwin/6/2021, ivr-227 15 µg b/austria/1359417/2021 - like strain (b/austria/1359417/2021 bvr-26 15 µg b/phuket/3073/2013 - like strain (b/phuket/3073/2013, wild type) - vaccines

European Union - English - EMA (European Medicines Agency)

novartis vaccines and diagnostics s.r.l. - influenza virus surface antigens (haemagglutinin and neuraminidase) of strain a/viet nam/1194/2004 (h5n1) - influenza, human, immunization, disease outbreaks - vaccines, - active immunisation against h5n1 subtype of influenza a virus., this indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing a/vietnam/1194/2004 (h5n1)-like strain., prepandemic influenza vaccine (h5n1) novartis vaccines and diagnostic should be used in accordance with official recommendations.,

Ireland - English - HPRA (Health Products Regulatory Authority)

seqirus s.r.l. - a/guangdong-maonan/swl 1536/2019 (h1n1)pdm09-like strain (a/guangdong-maonan/swl 1536/2019, cnic-1909); a/hong kong/2671/2019 (h3n2)-like strain (a/hong kong/2671/2019, ivr-208); b/washington/02/2019-like strain (b/washington/02/2019, wild type) - suspension for injection in pre-filled syringe - . - influenza vaccines; influenza, inactivated, split virus or surface antigen - influenza vaccine - prophylaxis of influenza, especially in those who run an increased risk of associated complications