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.

New Zealand - English - 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - neisseria meningitidis group a polysaccharide 10ug (conjugated to tetanus toxoid); neisseria meningitidis group c polysaccharide 10ug (conjugated to tetanus toxoid); neisseria meningitidis group w135 polysaccharide 10ug (conjugated to tetanus toxoid); neisseria meningitidis group y polysaccharide 10ug (conjugated to tetanus toxoid) - solution for injection - 0.5 ml - active: neisseria meningitidis group a polysaccharide 10ug (conjugated to tetanus toxoid) neisseria meningitidis group c polysaccharide 10ug (conjugated to tetanus toxoid) neisseria meningitidis group w135 polysaccharide 10ug (conjugated to tetanus toxoid) neisseria meningitidis group y polysaccharide 10ug (conjugated to tetanus toxoid) excipient: sodium acetate sodium chloride tetanus toxoid water for injection - menquadfi is indicated for active immunisation for the prevention of invasive meningococcal disease caused by neisseria meningitidis serogroups a, c, w and y. the use of menquadfi should be in accordance with official recommendations.

European Union - English - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinuria, paroxysmal - selective immunosuppressants - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with 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 (see section 5.1).atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5.1).generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive.neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5.1).ultomiris is indicated in the treatment of adult patients 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 adult patients 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.

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - meningococcal vaccines group a; meningococcal vaccines group c; meningococcal vaccines group w; meningococcal vaccines group y - powder and solution for solution for injection - meningococcal vaccines group y 5 mcg / 0.5 ml; meningococcal vaccines group w 5 mcg / 0.5 ml; meningococcal vaccines group c 5 mcg / 0.5 ml; meningococcal vaccines group a 10 mcg / 0.5 ml - other meningococcal monovalent purified polysaccharides antigen - other meningococcal monovalent purified polysaccharides antigen - menveo is indicated for active immunization of children (2 years of age and above), adolescents and adults up to the age of 55 years, 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.

Israel - English - Ministry of Health

sanofi israel ltd - meningococcal vaccines group a; meningococcal vaccines group c; meningococcal vaccines group w; meningococcal vaccines group y - solution for injection - meningococcal vaccines group c 4 mcg / 0.5 ml; meningococcal vaccines group y 4 mcg / 0.5 ml; meningococcal vaccines group w 4 mcg / 0.5 ml; meningococcal vaccines group a 4 mcg / 0.5 ml - other meningococcal monovalent purified polysaccharides antigen - other meningococcal monovalent purified polysaccharides antigen - active immunization of individuals 9 months through 55 years of age for the prevention of invasive meningococcal disease caused by n meningitidis serogroups a, c, y, and w-135 menactra vaccine does not prevent n meningitidis serogroup b disease.

Malaysia - English - 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 - English - 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 - English - 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.

European Union - English - 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.,