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

glaxosmithkline uk ltd - neisseria meningitidis group c strain c11 capsular polysaccharide tetanus toxoid conjugate; haemophilus influenzae type b polysaccharide tetanus toxoid conjugate - powder and solvent for solution for injection

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

sanofi pasteur inc. - neisseria meningitidis group a capsular polysaccharide tetanus toxoid conjugate antigen (unii: t4gyx3110d) (neisseria meningitidis group a capsular polysaccharide tetanus toxoid conjugate antigen - unii:t4gyx3110d), neisseria meningitidis group c capsular polysaccharide tetanus toxoid conjugate antigen (unii: zt89e5a103) (neisseria meningitidis group c capsular polysaccharide tetanus toxoid conjugate antigen - unii:zt89e5a103), neisseria meningitidis group y capsular polysaccharide tetanus toxoid conjugate antigen (unii: 4wan8pqk15) (neisseria meningitidis group y capsular polysaccharide tetanus toxoid conjugate antigen - unii:4wan8pqk15), neisseria meningitidis group w-135 capsular polysaccharide tetanus toxoid conjugate antigen (unii: l77ok410kw) (neisseria meningitidis group w-135 capsular polysaccharide tetanus toxoid conjugate antigen - unii:l77ok410kw) - menquadfi® is a vaccine indicated for active immunization for the prevention of invasive meningococcal disease caused by neisseria meningitidis serogroups a, c, w, and y. menquadfi is indicated for use in individuals 2 years of age and older. menquadfi does not prevent n. meningitidis serogroup b disease. severe allergic reaction to any component of the vaccine, or after a previous dose of menquadfi or any other tetanus toxoid-containing vaccine [see description (11) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to menquadfi 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 and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. there are no clinical studies of menquadfi in pregnant women. available human data on menquadfi administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. a developmental toxicity study in female rabbits administered a full human dose (0.5 ml) prior to mating and during gestation period revealed no evidence of harm to the fetus due to menquadfi (see animal data ). data animal data in a developmental toxicity study, female rabbits received a human dose of menquadfi by intramuscular injection on five occasions: 30 days and 10 days prior to mating, gestation days 6, 12 and 27. no adverse effects on pre-weaning development up to post-natal day 35 were observed. there were no vaccine-related fetal malformations or variations observed. risk summary it is not known whether menquadfi is excreted in human milk. data are not available to assess the effects of menquadfi 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 menquadfi and any potential adverse effects on the breastfed child from menquadfi 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 menquadfi have not been established in individuals younger than 2 years of age in the us. a total of 249 participants 65 years of age and older, including 71 participants 75 years of age or older, in study 4 received one dose of menquadfi [see adverse reactions (6.1) and clinical studies (14.1) ]. menquadfi recipients ≥ 65 years of age had lower gmts and seroresponse rates for all serogroups compared to menquadfi recipients 56 through 64 years of age [see clinical studies (14.1) ].

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

pfizer europe ma eeig, belgium - tetanus toxoid,meningococcal group a (neisseria meningitidis) polysaccharide vaccine,meningococcal group c (neisseria meningitidis) polysaccharide,meningococcal group w (neisseria meningitidis) polysaccharide,meningococcal group y (neisseria meningitidis) polysaccharide - powder and solvent for solution for injection - 44,5,5,5,5 µg,

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

glaxosmithkline uk ltd - meningococcal group a oligosaccharide; meningococcal group y oligosaccharide; meningococcal group w135 oligosaccharide; meningococcal group c oligosaccharide - powder and solvent for solution for injection

European Union - English - EMA (European Medicines Agency)

pfizer europe ma eeig - pneumococcal polysaccharide serotype 1, pneumococcal polysaccharide serotype 3, pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 5, pneumococcal polysaccharide serotype 6a, pneumococcal polysaccharide serotype 6b, pneumococcal polysaccharide serotype 7f, pneumococcal polysaccharide serotype 9v, pneumococcal polysaccharide serotype 14, pneumococcal polysaccharide serotype 18c, pneumococcal polysaccharide serotype 19a, pneumococcal polysaccharide serotype 19f, pneumococcal polysaccharide serotype 23f - pneumococcal infections; immunization - vaccines - active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by streptococcus pneumoniae in infants, children and adolescents from 6 weeks to 17 years of age.active immunisation for the prevention of invasive disease caused by streptococcus pneumoniae in adults ≥18 years of age and the elderly.see sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes.the use of prevenar 13 should be determined on the basis of official recommendations taking into consideration the risk of invasive disease in different age groups, underlying comorbidities as well as the variability of serotype epidemiology in different geographical areas.

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

novartis vaccines and diagnostics s.r.l. - neisseria meningitidis group a capsular oligosaccharide diphtheria crm197 protein conjugate antigen (unii: 3o44u6xyqk) (neisseria meningitidis group a capsular oligosaccharide diphtheria crm197 protein conjugate antigen - unii:3o44u6xyqk) - neisseria meningitidis group a capsular oligosaccharide diphtheria crm197 protein conjugate antigen 10 ug in 0.5 ml

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

glaxosmithkline australia pty ltd - diphtheria crm197 protein, quantity: 16.7 microgram; meningococcal oligosaccharide group a, quantity: 10 microgram - injection, powder for - excipient ingredients: sucrose; monobasic potassium phosphate - menveo is indicated for active immunisation of infants and children (from 2 months of age), adolescents and adults to prevent invasive disease caused by neisseria meningitidis serogroups a, c, w-135 and y. the use of this vaccine should be in accordance with official recommendations.

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

sanofi-aventis australia pty ltd - diphtheria toxoid; meningococcal polysaccharide - group w135; meningococcal polysaccharide - group a; meningococcal polysaccharide - group y; meningococcal polysaccharide - group c -

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - salmonella typhi vi polysaccharide 25ug - solution for injection - 25µg/0.5ml - active: salmonella typhi vi polysaccharide 25ug excipient: dibasic sodium phosphate hydrochloric acid monobasic sodium phosphate dihydrate phenol sodium chloride sodium hydroxide water for injection - typhim vi™ is indicated for active immunisation against typhoid fever caused by salmonella typhi in individuals 2 years of age and over.

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - meningococcal vaccines group a 50 mcg / 0.5 ml; meningococcal vaccines group c 50 mcg / 0.5 ml - solution for injection - other meningococcal monovalent purified polysaccharides antigen - for the active immunization of adults and children over two years against meningococcal meningitis caused by group a, group c, group w 135 and group y meningococci.