Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - neisseria meningitides group b strain nz98/254; neisseria meningitidis group b fhbp fusion protein; neisseria meningitidis group b nada protein; neisseria meningitidis group b nhba fusion protein - suspension for injection - neisseria meningitides group b strain nz98/254 25 mcg; neisseria meningitidis group b fhbp fusion protein 50 mcg; neisseria meningitidis group b nada protein 50 mcg; neisseria meningitidis group b nhba fusion protein 50 mcg - meningococcus b, outer membrane vesicle vaccine - bexsero is indicated for active immunization of individuals from 2 months of age and older against invasive meningococcal disease caused by neisseria meningitidis group b.

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

pfizer australia pty ltd - neisseria meningitidis serogroup b recombinant lipidated- factor h binding protein subfamily a, quantity: 60 microgram; neisseria meningitidis serogroup b recombinant lipidated- factor h binding protein subfamily b, quantity: 60 microgram - injection, suspension - excipient ingredients: water for injections; aluminium phosphate; histidine; sodium chloride; polysorbate 80 - trumenba is indicated in individuals 10 years and older for active immunisation to prevent invasive meningococcal disease caused by neisseria meningitidis serogroup b.

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

glaxosmithkline biologicals sa - neisseria meningitidis group b nhba fusion protein antigen (unii: 28e911y7ae) (neisseria meningitidis group b nhba fusion protein antigen - unii:28e911y7ae), neisseria meningitidis group b fhbp fusion protein antigen (unii: 25db599g64) (neisseria meningitidis group b fhbp fusion protein antigen - unii:25db599g64), neisseria meningitidis group b nada protein antigen (unii: 1s25r442rs) (neisseria meningitidis group b nada protein antigen - unii:1s25r442rs), neisseria meningitidis group b strain nz98/254 outer membrane vesicle antigen (unii: 91523m4s24) (neisseria meningitidis group b strain nz98/254 outer membrane vesicle antigen - unii:91523m4s24) - neisseria meningitidis serogroup b nhba fusion protein antigen 50 ug in 0.5 ml - bexsero is a vaccine indicated for active immunization to prevent invasive disease caused by neisseria meningitidis serogroup b. bexsero is approved for use in individuals aged 10 through 25 years. approval of bexsero is based on demonstration of immune response, as measured by serum bactericidal activity against three serogroup b strains representative of prevalent strains in the united states. the effectiveness of bexsero against diverse serogroup b strains has not been confirmed. hypersensitivity, including severe allergic reaction, to any component of the vaccine, or after a previous dose of bexsero [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 no adequate and well-controlled studies of bexsero in pregnant women in the u.s. available human data on bexsero administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. a developmental toxicity study was performed in female rabbits administered bexsero prior to mating and during gestation. the dose was 0.5 ml at each occasion (a single human dose is 0.5 ml). this study revealed no adverse effects on fetal or pre-weaning development due to bexsero (see data) . data animal data: in a developmental toxicity study, female rabbits were administered bexsero by intramuscular injection on days 29, 15, and 1 prior to mating and on gestation days 7 and 20. the total dose was 0.5 ml at each occasion (a single human dose is 0.5 ml). no adverse effects on pre-weaning development up to postnatal day 29 were observed. there were no fetal malformations or variations observed. risk summary it is not known whether the vaccine components of bexsero are excreted in human milk. available data are not sufficient to assess the effects of bexsero on the breastfed infant or on milk production/excretion. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for bexsero and any potential adverse effects on the breastfed child from bexsero or from the underlying maternal condition. for preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. safety and effectiveness of bexsero have not been established in children younger than 10 years. safety and effectiveness of bexsero have not been established in adults older than 65 years.

European Union - English - EMA (European Medicines Agency)

pfizer europe ma eeig - neisseria meningitidis serogroup b fhbp (recombinant lipidated fhbp (factor h binding protein)) subfamily a; neisseria meningitidis serogroup b fhbp (recombinant lipidated fhbp (factor h binding protein)) subfamily b - meningitis, meningococcal - bacterial vaccines, meningococcal vaccines - trumenba is indicated for active immunisation of individuals 10 years and older to prevent invasive meningococcal disease caused by neisseria meningitidis serogroup b.the use of this vaccine should be in accordance with official recommendations.

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

sanofi pasteur inc. - neisseria meningitidis group a capsular polysaccharide diphtheria toxoid conjugate antigen (unii: re9a0h8oab) (neisseria meningitidis group a capsular polysaccharide diphtheria toxoid conjugate antigen - unii:re9a0h8oab), neisseria meningitidis group c capsular polysaccharide diphtheria toxoid conjugate antigen (unii: 2j57k2523t) (neisseria meningitidis group c capsular polysaccharide diphtheria toxoid conjugate antigen - unii:2j57k2523t), neisseria meningitidis group y capsular polysaccharide diphtheria - neisseria meningitidis group a capsular polysaccharide diphtheria toxoid conjugate antigen 4 ug in 0.5 ml - menactra® , meningococcal (groups a, c, y and w-135) polysaccharide diphtheria toxoid conjugate vaccine, is indicated for active immunization to prevent invasive meningococcal disease caused by neisseria meningitidis serogroups a, c, y and w-135. menactra is approved for use in individuals 9 months through 55 years of age. menactra does not prevent n meningitidis serogroup b disease. severe allergic reaction (eg, anaphylaxis) after a previous dose of a meningococcal capsular polysaccharide-, diphtheria toxoid- or crm197 -containing vaccine, or to any component of menactra [see description (11) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to menactra during pregnancy. to enroll in or obtain information about the registry, call sanofi pasteur at 1-800-822-2463. 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 an

Malta - English - Medicines Authority

pfizer hellas s.a. 243 messoghion ave., neo psychiko 15451, athens, greece - neisseria meningitidis, polysaccharide group, tetanus toxoid - suspension for injection - neisseria meningitidis polysaccharide group c tetanus toxoid - vaccines

Ireland - English - HPRA (Health Products Regulatory Authority)

pfizer healthcare ireland - neisseria meningitidis c; tetanus toxoid - suspension for injection in pre-filled syringe - 0.5 millilitre(s) - meningococcal vaccines - meningococcal vaccine - it is indicated for active immunisation in children from 2 months of age, adolescents and adults, for the prevention of invasive disease caused by neisseria meningitidis serogroup c.

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

novartis vaccines and diagnostics srl - neisseria meningitidis serogroup b nhba fusion protein antigen (unii: 28e911y7ae) (neisseria meningitidis serogroup b nhba fusion protein antigen - unii:28e911y7ae) - neisseria meningitidis serogroup b nhba fusion protein antigen 50 ug in 0.5 ml

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

wyeth pharmaceutical division of wyeth holdings llc - neisseria meningitidis group b recombinant lp2086 a05 protein variant antigen (unii: 583wcd0izi) (neisseria meningitidis group b recombinant lp2086 a05 protein variant antigen - unii:583wcd0izi), neisseria meningitidis group b recombinant lp2086 b01 protein variant antigen (unii: 7mbd4k530d) (neisseria meningitidis group b recombinant lp2086 b01 protein variant antigen - unii:7mbd4k530d) - neisseria meningitidis group b recombinant lp2086 a05 protein variant antigen 60 ug in 0.5 ml - trumenba is indicated for active immunization to prevent invasive disease caused by neisseria meningitidis serogroup b. trumenba is approved for use in individuals 10 through 25 years of age. severe allergic reaction (e.g. anaphylaxis) to any component of trumenba [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 no adequate and well-controlled studies of trumenba in pregnant women. available human data on trumenba administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. two developmental toxicity studies were performed in female rabbits administered trumenba prior to mating and during gestation. the dose was 0.5 ml at each occasion (a single human dose is 0.5 ml). these studies revealed no evidence of harm to the fet

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

sanofi pasteur inc. - neisseria meningitidis group a capsular polysaccharide antigen (unii: 1i86b47ny4) (neisseria meningitidis group a capsular polysaccharide antigen - unii:1i86b47ny4) - neisseria meningitidis group a capsular polysaccharide antigen 50 ug in 0.5 ml