ישראל - אנגלית - Ministry of Health

alexion pharma israel ltd - ravulizumab - concentrate for solution for infusion - ravulizumab 100 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 antiacetylcholine receptor (achr) antibody-positive.

קנדה - אנגלית - Health Canada

glaxosmithkline inc - meningococcal group a oligosaccharide; meningococcal group c oligosaccharide; meningococcal group w-135 oligosaccharide; meningococcal group y oligosaccharide; corynebacterium diphtheriae crm-197 protein - solution - 10mcg; 5mcg; 5mcg; 5mcg; 47mcg - meningococcal group a oligosaccharide 10mcg; meningococcal group c oligosaccharide 5mcg; meningococcal group w-135 oligosaccharide 5mcg; meningococcal group y oligosaccharide 5mcg; corynebacterium diphtheriae crm-197 protein 47mcg - vaccines

קנדה - אנגלית - Health Canada

glaxosmithkline inc - meningococcal group c oligosaccharide; corynebacterium diphtheriae crm-197 protein - suspension - 10mcg; 25mcg - meningococcal group c oligosaccharide 10mcg; corynebacterium diphtheriae crm-197 protein 25mcg - toxoids

האיחוד האירופי - אנגלית - EMA (European Medicines Agency)

hansa biopharma ab - imlifidase - desensitization, immunologic; kidney transplantation - immunosuppressants - idefirix is indicated for desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. the use of idefirix should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients.

דרום אפריקה - אנגלית - South African Health Products Regulatory Authority (SAHPRA)

sanofi-aventis south africa (pty) ltd - solution - 10 μg & 55 μg - each 0,5 ml solution contains neisseria meningitidis group a polysaccharide 10,0 μg neisseria meningitidis group c polysaccharide 10,0 μg neisseria meningitidis group y polysaccharide 10,0 μg neisseria meningitidis group w polysaccharide 10,0 μg tetanus toxoid carrier protein 55,0 μg

ארצות הברית - אנגלית - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - iptacopan hydrochloride (unii: xw5ck7c6yh) (iptacopan - unii:8e05t07z6w) - fabhalta is indicated for the treatment of adults with paroxysmal nocturnal hemoglobinuria (pnh). fabhalta is contraindicated: - in patients with serious hypersensitivity to iptacopan or any of the excipients. - for initiation in patients with unresolved serious infection caused by encapsulated bacteria, including streptococcus pneumoniae, neisseria meningitidis, or haemophilus influenzae type b. risk summary available data from clinical trials with fabhalta use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. there are risks to the mother and fetus associated with untreated pnh in pregnancy (see clinical considerations) . the use of fabhalta in pregnant women or women planning to become pregnant may be considered following an assessment of the risks and benefits. in animal reproduction studies, oral administration of iptacopan to pregnant rats and rabbits during organogenesis at exposures 4 to 6-times the human exposure (based on auc) at the maximum recommended human dose (mrhd) of 200 mg twice daily did not induce embryo or fetal toxicity (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of major birth defects, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk pnh in pregnancy is associated with adverse maternal outcomes, including worsening cytopenias, thrombosis, infections, bleeding, miscarriages, increased maternal mortality, and adverse fetal outcomes, including fetal death and premature delivery. data animal data in an embryo-fetal development study in rats, oral administration of iptacopan during organogenesis did not cause embryo-fetal toxicity when given up to the highest dose of 1,000 mg/kg/day, which corresponds to 4-times the mrhd based on auc. in an embryo-fetal development study in rabbits, oral administration of iptacopan during organogenesis did not cause embryo-fetal toxicity when given up to the highest dose of 450 mg/kg/day, which corresponds to 6-times the mrhd based on auc. in a pre- and postnatal development study in rats, oral administration of iptacopan during gestation, parturition, and lactation did not cause adverse effects in offspring when given up to the highest dose of 1,000 mg/kg/day, which corresponds to 4-times the mrhd based on auc. risk summary there are no data on the presence of iptacopan or its metabolite in either human or animal milk, the effects on the breastfed child or on milk production. since many medicinal products are secreted into human milk, and because of the potential for serious adverse reactions in a breastfed child, breastfeeding should be discontinued during treatment and for 5 days after the final dose. safety and effectiveness in pediatric patients with pnh have not been established. there were 29 pnh patients 65 years of age and older in apply-pnh and appoint-pnh [see clinical studies (14)] . of the total number of fabhalta-treated patients during the 24-week treatment period in these studies, 21 (20.6%) were 65 years of age and older, while 7 (6.9%) were 75 years of age and older. clinical studies of fabhalta did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. the use of fabhalta is not recommended in patients with severe renal impairment (estimated glomerular filtration rate (egfr) < 30 ml/min/1.73 m2 ) with or without hemodialysis. no dose adjustment is required in patients with mild (egfr 60 to < 90 ml/min/1.73 m2 ) or moderate (egfr 30 to < 60 ml/min/1.73 m2 ) renal impairment [see clinical pharmacology (12.3)] . the use of fabhalta is not recommended in patients with severe hepatic impairment (child-pugh class c). no dose adjustment is required for patients with mild (child-pugh class a) or moderate (child-pugh class b) hepatic impairment [see clinical pharmacology (12.3)] .

קנדה - אנגלית - Health Canada

alexion pharma gmbh - ravulizumab - solution - 10mg - ravulizumab 10mg - immunosuppressive agents

קנדה - אנגלית - Health Canada

alexion pharma gmbh - ravulizumab - solution - 300mg - ravulizumab 300mg

קנדה - אנגלית - Health Canada

alexion pharma gmbh - ravulizumab - solution - 1100mg - ravulizumab 1100mg

קנדה - אנגלית - 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