Unjoni Ewropea - Ingliż - 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.,

Kanada - Ingliż - Health Canada

pfizer canada ulc - meningococcal polysaccharide vaccine grp c; tetanus toxoid - suspension - 10mcg; 20mcg - meningococcal polysaccharide vaccine grp c 10mcg; tetanus toxoid 20mcg - vaccines

Belġju - Ingliż - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

pfizer sa-nv - neisseria meningitidis a+c+w+y, purified polysaccharides - powder and solvent for solution for injection - neisseria meningitidis a+c+w+y, purified polysaccharides - meningococcus a,c,y,w-135, tetravalent purified polysaccharides antigen

Belġju - Ingliż - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

pfizer - neisseria meningitidis a+c+w+y, purified polysaccharides - powder and solvent for solution for injection - neisseria meningitidis a+c+w+y, purified polysaccharides - meningococcus a,c,y,w-135, tetravalent purified polysaccharides antigen

Belġju - Ingliż - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

pfizer sa-nv - neisseria meningitidis a+c+w+y, purified polysaccharides - powder and solvent for solution for injection - neisseria meningitidis a+c+w+y, purified polysaccharides - meningococcus a,c,y,w-135, tetravalent purified polysaccharides antigen

Belġju - Ingliż - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

nuron biotech b.v. - neisseria meningitidis group c oligosaccharide conjugated to crm197 as a carrier - suspension for injection in pre-filled syringe - 10 µg - neisseria meningitidis c, oligosaccharide conjugated to crm 197 as a carrier - meningococcus c, purified polysaccharides antigen conjugated

Belġju - Ingliż - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

gsk vaccines s.r.l. - neisseria meningitidis group c oligosaccharide conjugated to crm197 as a carrier 10 µg - suspension for injection - 10 µg - neisseria meningitidis c, oligosaccharide conjugated to crm 197 as a carrier - meningococcus c, purified polysaccharides antigen conjugated

Belġju - Ingliż - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

gsk vaccines s.r.l. - neisseria meningitidis group c oligosaccharide conjugated to crm197 as a carrier 10 µg - suspension for injection in pre-filled syringe - 10 µg - neisseria meningitidis c, oligosaccharide conjugated to crm 197 as a carrier - meningococcus c, purified polysaccharides antigen conjugated

Stati Uniti - Ingliż - 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) ].

New Zealand - Ingliż - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - neisseria meningitidis group b factor h binding protein subfamily a 0.12 mg/ml;  ; neisseria meningitidis group b factor h binding protein subfamily b 0.12 mg/ml;   - suspension for injection - 120 mcg/0.5ml - active: neisseria meningitidis group b factor h binding protein subfamily a 0.12 mg/ml   neisseria meningitidis group b factor h binding protein subfamily b 0.12 mg/ml   excipient: aluminium as aluminium phosphate histidine polysorbate 80 sodium chloride water for injection - trumenba is indicated in individuals 10 years and older for active immunisation to prevent invasive meningococcal disease caused by neisseria meningitidis serogroup b.