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

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

glaxo saudi arabia ltd, saudi arabia - recombinant neisseria meningitidis group b nhba fusion protein the nhba,recombinant neisseria meningitidis group b nhba fusion protein the nhba i,recombinant n meningitidis serogroup b nada protein,recombinant n meningitidis serogroup b nada protein i,recombinant n meningitidis serogroup b fhbp fusion protein,recombinant n meningitidis serogroup b fhbp fusion protein i,outer membrane vesicles from n meningitidis serogroup b strain nz98254 - suspension for injection in pre-filled syringe - 50,50,50,50,50,50,50 µg,

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.

European Union - English - EMA (European Medicines Agency)

intervet international b.v. - inactivated leptospira strains: l. interrogans serogroup canicola serovar portland-vere (strain ca-12-000); l. interrogans serogroup icterohaemorrhagiae serovar copenhageni (strain ic-02-001); l. interrogans serogroup australis serovar bratislava (strain as-05-073); l. kirschneri serogroup grippotyphosa serovar dadas (strain gr-01-005) - immunologicals for canidae, inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia) - dogs - for active immunisation of dogs against:l. interrogans serogroup canicola serovar canicola to reduce infection and urinary excretion;l. interrogans serogroup icterohaemorrhagiae serovar copenhageni to reduce infection and urinary excretion;l. interrogans serogroup australis serovar bratislava to reduce infection;l. kirschneri serogroup grippotyphosa serovar bananal/lianguang to reduce infection and urinary excretion.

European Union - English - EMA (European Medicines Agency)

intervet international bv - leptospira interrogans serogroup canicola serovar portland-vere (strain ca-12-000), l. interrogans serogroup icterohaemorrhagiae serovar copenhageni (strain ic-02-001), l. interrogans serogroup australis serovar bratislava (strain as-05-073), l. kirschneri serogroup grippotyphosa serovar dadas (strain gr-01-005) - immunologicals - dogs - for active immunisation of dogs against:leptospira interrogans serogroup canicola serovar canicola to reduce infection and urinary excretion;l. interrogans serogroup icterohaemorrhagiae serovar copenhageni to reduce infection and urinary excretion;l. interrogans serogroup australis serovar bratislava to reduce infection;l. kirschneri serogroup grippotyphosa serovar bananal / lianguang to reduce infection and urinary excretion.

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.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

intervet australia pty limited - l. interrogans serogroup australis serovar bratislava - unknown - l. interrogans serogroup australis serovar bratislava vaccine active 0.0 - active constituent

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

biogrow australia pty ltd - sodium metabisulfite - slow release generator (inc. flea collars) - sodium metabisulfite mineral-sodium active 980.0 g/kg - fungicide

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

medigroup pty ltd - 35225 - pressure alleviation pad, - a personal protective pad for use with a nasal canula/oxygen tubes.

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

medigroup pty ltd - 44096 - surgical procedure kit, laparoscopic, single-use, non-medicated - artisential gastric bypass and gastrectomy kit is intended for single use in minimally invasive laparoscopic surgical applications. the fully articulated instrument designed to grasp a suture needle when pushing/ pulling the needle and attached suture through tissue during suturing; implanting, explanting, repositioning mesh or other prosthesis to tissues. the sutures are intended for use in soft tissue to provide wound, tissue, mesh or other prosthesis support, but not for use in cardiovascular or neurological surgery. the wound closure device with a surgical needle intended for single use for soft tissue approximation.