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 dibasic sodium phosphate monobasic potassium phosphate monobasic sodium phosphate potassium chloride sodium chloride water for injection - for the prevention of influenza caused by influenza virus, types a and b contained in the vaccine. afluria quad vaccine is indicated for use in persons aged 3 years and over. for full details regarding recommendations for influenza vaccination, please refer to the relevant national immunisation guidelines.

Malta - English - Medicines Authority

glaxosmithkline biologicals s.a. rue de l'institut 89 b-1330 rixensart, belgium - a, brisbane, h, ivr, kansas, nymc x, phuket, wild type, nymc bx - suspension for injection in pre-filled syringe - a/darwin/9/2021 (h3n2) - like strain (a/darwin/6/2021, ivr-227 15 µg b/phuket/3073/2013 - like strain (b/phuket/3073/2013, wild type) 15 µg b/austria/1359417/2021 - like strain (b/austria/1359417/2021 bvr-26 15 µg a/victoria/4897/2022 (h1n1) pdm09 - like strain (a/victoria/4897/2022 ivr-238 15 µg - vaccines

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

seqirus, inc. - influenza a virus a/singapore/gp1908/2015 ivr-180 (h1n1) antigen (mdck cell derived, propiolactone inactivated) (unii: qwjhw3wexs) (influenza a virus a/singapore/gp1908/2015 ivr-180 (h1n1) hemagglutinin antigen (mdck cell derived, propiolactone inactivated) - unii:55qh9pjkdv) - influenza a virus a/singapore/gp1908/2015 ivr-180 (h1n1) antigen (mdck cell derived, propiolactone inactivated) 15 ug in 0.5 ml

European Union - English - EMA (European Medicines Agency)

gsk vaccines s.r.l. - meningococcal group a, c, w-135 and y conjugate vaccine - immunization, meningitis, meningococcal - bacterial vaccines - prefilled syringe menveo is indicated for active immunisation of adolescents (from 11 years of age) and adults at risk of exposure to neisseria meningitidis groups a, c, w135 and y, to prevent invasive disease. the use of this vaccine should be in accordance with official recommendations. vials menveo is indicated for active immunisation of children (from two years of age), adolescents and adults at risk of exposure to neisseria meningitidis groups a, c, w135 and y, to prevent invasive disease. the use of this vaccine should be in accordance with official recommendations.,

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

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

European Union - English - EMA (European Medicines Agency)

merck sharp & dohme b.v. - virus, live attenuated, measles, virus, live attenuated, mumps, virus, live attenuated, rubella, virus, live attenuated, varicella - chickenpox; rubella; measles; mumps; immunization - vaccines - proquad is indicated for simultaneous vaccination against measles, mumps, rubella and varicella in individuals from 12 months of age. proquad can be administered to individuals from 9 months of age under special circumstances (e.g., to conform with national vaccination schedules, outbreak situations, or travel to a region with high prevalence of measles.,

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - influenza virus a (h1n1) haemagglutinin 15ug (a/victoria/4897/2022 (h1n1) pdm09-like strain (a/victoria/4897/2022, ivr-238)); influenza virus a (h3n2) haemagglutinin 15ug (a/thailand/8/2022 (h3n2)-like strain (a/thailand/8/2022, ivr-237)); influenza virus b (victoria) haemagglutinin 15ug (b/austria/1359417/2021-like strain (b/austria/1359417/2021, bvr-26)); influenza virus b (yamagata) haemagglutinin 15ug (b/phuket/3073/2013-like strain (b/phuket/3073/2013, wild type)) - suspension for injection - 0.5 ml - active: influenza virus a (h1n1) haemagglutinin 15ug (a/victoria/4897/2022 (h1n1) pdm09-like strain (a/victoria/4897/2022, ivr-238)) influenza virus a (h3n2) haemagglutinin 15ug (a/thailand/8/2022 (h3n2)-like strain (a/thailand/8/2022, ivr-237)) influenza virus b (victoria) haemagglutinin 15ug (b/austria/1359417/2021-like strain (b/austria/1359417/2021, bvr-26)) influenza virus b (yamagata) haemagglutinin 15ug (b/phuket/3073/2013-like strain (b/phuket/3073/2013, wild type)) excipient: calcium chloride dihydrate dibasic sodium phosphate as dihydrate 0.67 mg magnesium chloride hexahydrate monobasic potassium phosphate potassium chloride sodium chloride water for injection - for the prevention of influenza caused by influenza virus, types a and b. for full details regarding recommendations for influenza vaccination, please refer to the relevant national immunisation guidelines. influvac tetra is indicated in adults and children from 6 months of age and older.