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

seqirus, inc. - influenza a virus a/victoria/2454/2019 ivr-207 (h1n1) antigen (formaldehyde inactivated) (unii: 2j002y0b0w) (influenza a virus a/victoria/2454/2019 ivr-207 (h1n1) hemagglutinin antigen (formaldehyde inactivated) - unii:mz5g0f0san), influenza a virus a/hong kong/2671/2019 ivr-208 (h3n2) antigen (formaldehyde inactivated) (unii: p8orn3uom6) (influenza a virus a/hong kong/2671/2019 ivr-208 (h3n2) hemagglutinin antigen (formaldehyde inactivated) - unii:thg3pu0kok), influenza b virus b/victoria/705/2018 bvr-11 - fluad quadrivalent is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes a and types b contained in the vaccine. fluad quadrivalent is approved for use in persons 65 years of age and older. this indication is approved under accelerated approval based on the immune response elicited by fluad quadrivalent [see clinical studies (14.1)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. do not administer fluad quadrivalent to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine, including egg protein [see description (11)] , or to a previous influenza vaccine. risk summary fluad quadrivalent is not approved for use in persons < 65 years of age. there are insufficient human data to establish whether there is a vaccine-associated risk with use of fluad quadrivalent in pregnancy. there were no development

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

seqirus, inc. - influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) antigen (formaldehyde inactivated) (unii: wd5e5vym2e) (influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) hemagglutinin antigen (formaldehyde inactivated) - unii:erb9sj9vmq), influenza a virus a/cambodia/e0826360/2020 ivr-224 (h3n2) antigen (formaldehyde inactivated) (unii: yy2tbu8yqs) ( iinfluenza a virus a/cambodia/e0826360/2020 ivr-224 (h3n2) hemagglutinin antigen (formaldehyde inactivated) - unii:33qej7v9bf), influenza b virus b/victoria/705/201 - fluad quadrivalent is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes a and types b contained in the vaccine. fluad quadrivalent is approved for use in persons 65 years of age and older. this indication is approved under accelerated approval based on the immune response elicited by fluad quadrivalent [see clinical studies (14.1)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. do not administer fluad quadrivalent to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine, including egg protein [see description (11)] , or to a previous influenza vaccine. risk summary fluad quadrivalent is not approved for use in persons < 65 years of age. there are insufficient human data to establish whether there is a vaccine-associated risk with use of fluad quadrivalent in pregnancy. there were no development

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

sanofi-aventis australia pty ltd - influenza haemagglutinin recombinant, quantity: 45 microgram - injection, solution - excipient ingredients: dibasic sodium phosphate; sodium chloride; polysorbate 20; monobasic sodium phosphate; water for injections - flublok quadrivalent is indicated for active immunisation for the prevention of influenza disease caused by influenza virus types a and b contained in the vaccine. flublok quadrivalent is approved for use in persons 18 years of age and older.

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

glaxosmithkline australia pty ltd - influenza virus haemagglutinin -

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

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

seqirus pty ltd - influenza a virus a/singapore/gp1908/2015 ivr-180a (h1n1) antigen (propiolactone inactivated) (unii: 9jwn7vdq7n) (influenza a virus a/singapore/gp1908/2015 ivr-180a (h1n1) hemagglutinin antigen (propiolactone inactivated) - unii:u6c4gj6wzg), influenza a virus a/singapore/infimh-16-0019/2016 ivr-186 (h3n2) antigen (propiolactone inactivated) (unii: a5wli8wk8a) (influenza a virus a/singapore/infimh-16-0019/2016 ivr-186 (h3n2) hemagglutinin antigen (propiolactone inactivated) - unii:37h6eg2naq), influenza b vi - influenza a virus a/singapore/gp1908/2015 ivr-180a (h1n1) hemagglutinin antigen (propiolactone inactivated) 15 ug in 0.5 ml - afluria® quadrivalent is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza a subtype viruses and type b viruses contained in the vaccine. afluria quadrivalent is approved for use in persons 5 years of age and older. afluria quadrivalent is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine (see description [11]) . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to afluria quadrivalent during pregnancy. women who are vaccinated with afluria quadrivalent during pregnancy are encouraged to enroll in the registry by calling 1-855-358-8966 or sending an email to seqirus at us.medicalinformation@seqirus.com. risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated backg

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

protein sciences corporation - influenza a virus a/michigan/45/2015 (h1n1) recombinant hemagglutinin antigen (unii: 69h0yj871t) (influenza a virus a/michigan/45/2015 (h1n1) recombinant hemagglutinin antigen - unii:69h0yj871t) - influenza a virus a/michigan/45/2015 (h1n1) recombinant hemagglutinin antigen 45 ug in 0.5 ml

Israel - English - Ministry of Health

astrazeneca (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 - nasal spray, suspension - b/phuket/3073/2013 (b/yamagata lineage)-like virus 7 ±0.5 log10 ffu^a / 0.2 ml; a/darwin/9/2021 (h3n2)-like virus 7 ±0.5 log10 ffu^a / 0.2 ml; b/austria/1359417/2021 (b/victoria lineage)-like virus 7 ±0.5 log10 ffu^a / 0.2 ml; a/victoria/4897/2022 (h1n1)pdm09-like virus 7 ±0.5 log10 ffu^a / 0.2 ml - influenza, inactivated, split virus or surface antigen - influenza, purified antigen - flumist quadrivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza a subtype viruses ad type b viruses contained in the vaccine. flumist quadrivalent is approved for use in persons 2 through 49 years of age.

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

glaxosmithkline biologicals sa - influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (formaldehyde inactivated) (unii: au5c98u4bb) (influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) hemagglutinin antigen (formaldehyde inactivated) - unii:c46xjt9fq9), influenza a virus a/darwin/6/2021 ivr-227 (h3n2) antigen (formaldehyde inactivated) (unii: f5qv7af326) (influenza a virus a/darwin/6/2021 ivr-227 (h3n2) hemagglutinin antigen (formaldehyde inactivated) - unii:n969qk7xd2), influenza b virus b/austria/1359417/2021 bvr-26 antigen - influenza a virus a/singapore/gp1908/2015 ivr-180 (h1n1) hemagglutinin antigen (formaldehyde inactivated) 15 ug in 0.5 ml - fluarix quadrivalent is indicated for active immunization for the prevention of disease caused by influenza a subtype viruses and type b viruses contained in the vaccine [see description (11)] . fluarix quadrivalent is approved for use in persons aged 6 months and older. do not administer fluarix quadrivalent to anyone with a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or following a previous administration of any influenza vaccine [see description (11)] . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. available data from a pregnancy registry do not suggest an increased risk of major birth defects and miscarriage in individuals who received fluarix quadrivalent within 28 days prior to conception or during pregnancy (see d

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

seqirus, inc. - influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (formaldehyde inactivated) (unii: au5c98u4bb) (influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) hemagglutinin antigen (formaldehyde inactivated) - unii:c46xjt9fq9), influenza a virus a/darwin/6/2021 ivr-227 (h3n2) antigen (formaldehyde inactivated) (unii: f5qv7af326) (influenza a virus a/darwin/6/2021 ivr-227 (h3n2) hemagglutinin antigen (formaldehyde inactivated) - unii:n969qk7xd2), influenza b virus b/austria/1359417/2021 bvr-26 antigen - fluad quadrivalent is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes a and types b contained in the vaccine. fluad quadrivalent is approved for use in persons 65 years of age and older. this indication is approved under accelerated approval based on the immune response elicited by fluad quadrivalent [see clinical studies (14.1)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. do not administer fluad quadrivalent to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine, including egg protein [see description (11)] , or to a previous influenza vaccine. risk summary fluad quadrivalent is not approved for use in persons < 65 years of age. there are insufficient human data to establish whether there is a vaccine-associated risk with use of fluad quadrivalent in pregnancy. there were no development