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

pfizer (malaysia) sdn. bhd. - meningococcus a, purified polysaccharides antigen; meningococcus w135, purified polysaccharides antigen; meningococcus y, purified polysaccharides antigen; meningococcus c, purified polysaccharides antigen conjugated -

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

sanofi-aventis (malaysia) sdn. bhd. - purified meningococcal polysaccharide group a; purified meningococcal polysaccharide group c; purified meningococcal polysaccharide group y; purified meningococcal polysaccharide group w135 -

Israel - Tiếng Anh - Ministry of Health

alexion pharma israel ltd - ravulizumab - concentrate for solution for infusion - ravulizumab 10 mg/ml - ravulizumab - ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with paroxysmal nocturnal haemoglobinuria (pnh): • in patients with haemolysis with clinical symptom(s) indicative of high disease activity. • in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.ultomiris is indicated in the treatment of adult patients with generalized myasthenia gravis (gmg) who are anti-acetylcholine receptor (achr) antibody-positive.

Hoa Kỳ - Tiếng Anh - 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) ].

Liên Minh Châu Âu - Tiếng Anh - EMA (European Medicines Agency)

gsk vaccines s.r.l. - outer membrane vesicles from neisseria meningitidis group b (strain nz 98/254), recombinant neisseria meningitidis group b fhbp fusion protein, recombinant neisseria meningitidis group b nada protein, recombinant neisseria meningitidis group b nhba fusion protein - meningitis, meningococcal - meningococcal vaccines - active immunisation against invasive disease caused by neisseria meningitidis serogroup-b strains.,

Liên Minh Châu Âu - Tiếng Anh - EMA (European Medicines Agency)

pfizer europe ma eeig - neisseria meningitidis group a polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group c polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group w-135 polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group y polysaccharide conjugated to tetanus toxoid - meningitis, meningococcal - vaccines - nimenrix is indicated for active immunisation of individuals from the age of 6 weeks against invasive meningococcal diseases caused by neisseria meningitidis group a, c, w-135, and y.

Liên Minh Châu Âu - Tiếng Anh - 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.

Hoa Kỳ - Tiếng Anh - 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

Liên Minh Châu Âu - Tiếng Anh - EMA (European Medicines Agency)

sanofi pasteur - neisseria meningitidis group c polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group a polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group y polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group w-135 polysaccharide conjugated to tetanus toxoid - meningitis, meningococcal - vaccines - menquadfi is indicated for active immunisation of individuals from the age of 12 months and older against invasive meningococcal disease caused by neisseria meningitidis serogroups a, c, w, and y.the use of this vaccine should be in accordance with available official recommendations.

Liên Minh Châu Âu - Tiếng Anh - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - pegcetacoplan - hemoglobinuria, paroxysmal - immunosuppressants - aspaveli is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh) who are anaemic after treatment with a c5 inhibitor for at least 3 months.