Ireland - English - HPRA (Health Products Regulatory Authority)

sanofi pasteur msd ltd - a/california/7/2009 (h1n1)pdm09 - derived strain used nymc x-179a, 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 %v/v - influenza vaccines

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/hong kong/4801/2014 (h3n2) recombinant hemagglutinin antigen (unii: 2i1eol437m) (influenza a virus a/hong kong/4801/2014 (h3n2) recombinant hemagglutinin antigen - unii:2i1eol437m), influenza b virus b/brisbane/60/2008 recombinant hemagglutinin antigen (unii: 058u2312cr) (influenza b virus b/bri - influenza a virus a/michigan/45/2015 (h1n1) recombinant hemagglutinin antigen 45 ug in 0.5 ml - flublok is a vaccine indicated for active immunization against disease caused by influenza a virus subtypes and influenza type b virus contained in the vaccine. flublok is approved for use in persons 18 years of age and older. flublok is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine (see postmarketing experience [6.2] and description [11] ). pregnancy outcomes in women who have been exposed to flublok during pregnancy are being monitored. contact: protein sciences corporation by calling 1-888-855-7871. all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. available data on flublok administered to pregnant women are insufficient to inform vaccine-associated risks in pregnant women. a developmental study of flublok has been performed in

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)

id biomedical corporation of quebec - influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (uv, formaldehyde inactivated) (unii: a5pts27urj) (influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) hemagglutinin antigen (uv, formaldehyde inactivated) - unii:9ha5c4xl36), influenza a virus a/darwin/9/2021 ivr-228 (h3n2) antigen (uv, formaldehyde inactivated) (unii: p483j7gx6d) (influenza a virus a/darwin/9/2021 ivr-228 (h3n2) hemagglutinin antigen (uv, formaldehyde inactivated) - unii:grn94tp8yv), influenza b virus b/austria/1359417/2021 - influenza a virus a/singapore/gp1908/2015 ivr-180 (h1n1) hemagglutinin antigen (uv, formaldehyde inactivated) 15 ug in 0.5 ml - flulaval 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. flulaval quadrivalent is approved for use in persons aged 6 months and older. do not administer flulaval 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 dose 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. there are insufficient data on flulaval quadrivalent in pregnant women to inform vaccine-associated risks. a developmental toxicity study was performed in female rats administered flulaval quadrivalent prior to mating and during gestation and lactation p

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

sanofi pasteur inc. - influenza a virus a/wisconsin/588/2019 (h1n1) recombinant hemagglutinin antigen (unii: gb6adz2asn) (influenza a virus a/wisconsin/588/2019 (h1n1) recombinant hemagglutinin antigen - unii:gb6adz2asn), influenza a virus a/darwin/6/2021 (h3n2) recombinant hemagglutinin antigen (unii: 7vj7x8pkx3) (influenza a virus a/darwin/6/2021 (h3n2) recombinant hemagglutinin antigen - unii:7vj7x8pkx3), influenza b virus b/austria/1359417/2021 recombinant hemagglutinin antigen (unii: m48387n67g) (influenza b virus b/aust - flublok quadrivalent is a vaccine indicated for active immunization against disease caused by influenza a subtype viruses and type b viruses contained in the vaccine. flublok quadrivalent is approved for use in persons 18 years of age and older [see clinical studies (14)] . flublok quadrivalent is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine [see postmarketing experience (6.2) and description (11)] . pregnancy exposure pregnancy outcomes in women who have been exposed to flublok quadrivalent during pregnancy are being monitored. sanofi pasteur inc. is maintaining a prospective pregnancy exposure registry to collect data on pregnancy outcomes and newborn health status following vaccination with flublok quadrivalent during pregnancy. healthcare providers are encouraged to enroll women who receive flublok quadrivalent during pregnancy in sanofi pasteur inc.'s vaccination pregnancy registry by calling 1-800-822-2463. risk summary all pre

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

seqirus inc. - influenza a virus a/nebraska/14/2019 (h1n1) antigen (mdck cell derived, propiolactone inactivated) (unii: ezq32tf2as) (influenza a virus a/nebraska/14/2019 (h1n1) hemagglutinin antigen (mdck cell derived, propiolactone inactivated) - unii:jtd2pe1hfr), influenza a virus a/delaware/39/2019 (h3n2) antigen (mdck cell derived, propiolactone inactivated) (unii: 5mir93vlg8) (influenza a virus a/delaware/39/2019 (h3n2) hemagglutinin antigen (mdck cell derived, propiolactone inactivated) - unii:jx3jfh4h9s), influe - flucelvax quadrivalent is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes a and types b contained in the vaccine. flucelvax quadrivalent is approved for use in persons 2 years of age and older. [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)] . 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. there are insufficient data for flucelvax quadrivalent in pregnant women to inform vaccine-associated risks in pregnancy. there were no developmental toxicity studies of flucelvax quadrivalent performed in animals. a developmental toxicity study has been performed in female ra

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

seqirus inc. - influenza a virus a/washington/19/2020 (h1n1) antigen (mdck cell derived, propiolactone inactivated) (unii: 3yn85tu9mj) (influenza a virus a/washington/19/2020 (h1n1) hemagglutinin antigen (mdck cell derived, propiolactone inactivated) - unii:32ss7wu2j7), influenza a virus a/tasmania/503/2020 (h3n2) antigen (mdck cell derived, propiolactone inactivated) (unii: 6er9j3gb63) (influenza a virus a/tasmania/503/2020 (h3n2) hemagglutinin antigen (mdck cell derived, propiolactone inactivated) - unii:bun3xfj2b3), - flucelvax quadrivalent is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes a and types b contained in the vaccine. flucelvax quadrivalent is approved for use in persons 6 months of age and older. [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)] . 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. there are insufficient data for flucelvax quadrivalent in pregnant women to inform vaccine-associated risks in pregnancy. there were no developmental toxicity studies of flucelvax quadrivalent performed in animals. a developmental toxicity study has been performed in female r

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

seqirus inc. - influenza a virus a/georgia/12/2022 cvr-167 (h1n1) antigen (mdck cell derived, propiolactone inactivated) (unii: b8p3xn76w4) (influenza a virus a/georgia/12/2022 cvr-167 (h1n1) hemagglutinin antigen (mdck cell derived, propiolactone inactivated) - unii:n8jks3vk2a), influenza a virus a/darwin/11/2021 (h3n2) antigen (mdck cell derived, propiolactone inactivated) (unii: pv9k2r8hrm) (influenza a virus a/darwin/11/2021 (h3n2) hemagglutinin antigen (mdck cell derived, propiolactone inactivated) - unii:c6pm4nxj3 - flucelvax quadrivalent is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes a and types b contained in the vaccine. flucelvax quadrivalent is approved for use in persons 6 months of age and older. [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)] . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the us 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. data collected in a prospective pregnancy exposure registry from 665 women vaccinated with flucelvax quadrivalent showed no evidence of a vaccine-associated increase in the risk of major birth defects and miscarriages when flucelvax quadrivalent is administered during any trime

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

sanofi-aventis (malaysia) sdn. bhd. - influenza split virus, inactivated -

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

seqirus vaccines ltd - influenza virus surface antigens - suspension for injection