Israel - English - Ministry of Health

sanofi 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; 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 - vaxigrip tetra is indicated 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 for:- active immunisation of adults, including pregnant women, and children from 6 months of age and older- passive protection of infant(s) from birth to less than 6 months of age following vaccination of pregnant women.the use of vaxigrip tetra should be based on official recommendations.

Ireland - English - HPRA (Health Products Regulatory Authority)

sanofi pasteur msd ltd - a/california/7/2009 (h1n1)v like strain (x-179a) a/california/7/2009 (h1n1) - derived strain used nymc x-181 reass b/brisbane/60/2008 - like strain (b/brisbane/60/2008) - suspension for injection - 7.5 mcg ea %v/v

New Zealand - English - Medsafe (Medicines Safety Authority)

seqirus (nz) ltd - influenza virus a/california/7/2009 (h1n1) - like strain 15ug - suspension for injection - 15 mcg/0.5ml - active: influenza virus a/california/7/2009 (h1n1) - like strain 15ug excipient: calcium chloride dihydrate dibasic sodium phosphate monobasic potassium phosphate monobasic sodium phosphate dihydrate potassium chloride sodium chloride thiomersal water for injection - for active immunisation to prevent influenza disease caused by the influenza a(h1n1) virus, in adults, adolescents and children 10 years of age and older.

Ireland - English - HPRA (Health Products Regulatory Authority)

sanofi pasteur msd ltd - a/california/7/2009 (h1n1)pdm09 - derived strain used nymc x-179a a/victoria/361/2011 (h3n2) - derived strain used ivr-165 b/massachusetts/2/2012 - suspension for injection - 7.5 mcg ea %v/v

Singapore - English - HSA (Health Sciences Authority)

seqirus pte. ltd. - influenza virus (sh) a/california/07/2009 (h1n1) pdm09- like strain; influenza virus (sh) a/hong kong/4801/2014 (h3n2) - like strain; influenza virus (sh) b/brisbane/60/2008 - like strain - injection - 15 mcg ha/0.5ml - influenza virus (sh) a/california/07/2009 (h1n1) pdm09- like strain 15 mcg ha/0.5ml; influenza virus (sh) a/hong kong/4801/2014 (h3n2) - like strain 15 mcg ha/0.5ml; influenza virus (sh) b/brisbane/60/2008 - like strain 15 mcg ha/0.5ml

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

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

European Union - English - EMA (European Medicines Agency)

seqirus netherlands b.v. - a/darwin/9/2021 (h3n2) - like strain (a/darwin/6/2021, ivr-227) / a/victoria/4897/2022 (h1n1) pdm09-like strain (a/victoria/4897/2022, ivr-238) / b/phuket/3073/2013-like strain (b/phuket/3073/2013, bvr-1b) / influenza virus b/austria/1359417/2021-like strain (b/austria/1359417/2021, bvr-26) - influenza, human - vaccines - prophylaxis of influenza in the elderly (65 years of age and older).fluad tetra should be used in accordance with official recommendations.

Malta - English - Medicines Authority

viatris healthcare limited damastown industrial park, mulhuddart, dublin 15, dublin , ireland - suspension for injection in pre-filled syringe - influenza vaccine (split virion, inactivated) 15 µg - vaccines

Singapore - English - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - purified antigen fractions of inactivated split virions - a/indonesia/05/2005 (h5n1)/pr8-ibcdc-rg2 - injection, emulsion - 3.75 µg haemagglutinin/0.25 ml - purified antigen fractions of inactivated split virions - a/indonesia/05/2005 (h5n1)/pr8-ibcdc-rg2 3.75 µg haemagglutinin/0.25 ml

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

seqirus, inc. - influenza a virus a/idaho/07/2018 (h1n1) antigen (mdck cell derived, propiolactone inactivated (unii: z6y9y35soy) (influenza a virus a/idaho/07/2018 (h1n1) hemagglutinin antigen (mdck cell derived, propiolactone inactivated) - unii:cj7119yk1w), influenza a virus a/indiana/08/2018 (h3n2) antigen (mdck cell derived, propiolactone inactivated) (unii: z5eje3ep8t) (influenza a virus a/indiana/08/2018 (h3n2) hemagglutinin antigen (mdck cell derived, propiolactone inactivated) - unii:4t55w47jol), influenza b vir - flucelvax quadrivalent is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes a and type b contained in the vaccine. flucelvax quadrivalent is approved for use in persons 4 years of age and older. for children and adolescents 4 through 17 years of age, approval is based on the immune response elicited by flucelvax quadrivalent. data demonstrating a decrease in influenza disease after vaccination of this age group with flucelvax quadrivalent are not available. [see clinical studies (14)] do not administer flucelvax quadrivalent to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine [see description (11) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to flucelvax quadrivalent during pregnancy. women who are vaccinated with flucelvax quadrivalent during pregnancy are encouraged to enroll in the registry by calling