Սինգապուր - անգլերեն - HSA (Health Sciences Authority)

astrazeneca singapore pte ltd - eculizumab - infusion, solution concentrate - 300 mg / vial - eculizumab 300 mg / vial

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

astrazeneca pty ltd - budesonide, quantity: 400 microgram/actuation - insufflation - excipient ingredients: - treatment of bronchial asthma. indications as at 3 june 1994: treatment of bronchial asthma. may also be used when replacement or reduction in oral steroid therapy is desired.

Նոր Զելանդիա - անգլերեն - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - eculizumab 300mg;  ;  ;   - solution for infusion - 300mg/30ml - active: eculizumab 300mg       excipient: dibasic sodium phosphate heptahydrate monobasic sodium phosphate monohydrate polysorbate 80 sodium chloride water for injection - soliris® is indicated for the treatment of patients with paroxysmal nocturnal haemoglobinuria (pnh)to reduce haemolysis.

Կանադա - անգլերեն - Health Canada

baxter corporation - mannitol; sorbitol - liquid - 500mg; 2.5g - mannitol 500mg; sorbitol 2.5g - irrigating solutions

Սաուդյան Արաբիա - անգլերեն - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

alexion europe sas, france - sebelipase alfa - concentrate for solution for infusion - 2 mg/ml

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

alexion pharmaceuticals australasia pty ltd - selumetinib sulfate, quantity: 30.25 mg (equivalent: selumetinib, qty 25 mg) - capsule, hard - excipient ingredients: carnauba wax; hypromellose; titanium dioxide; carrageenan; shellac; iron oxide red; purified water; iron oxide yellow; tocofersolan; indigo carmine aluminium lake; glyceryl monooleate; potassium chloride; indigo carmine - koselugo is indicated for the treatment of paediatric patients aged 2 years and above, with neurofibromatosis type 1 (nf1) who have symptomatic, inoperable plexiform neurofibromas (pn).

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

alexion pharmaceuticals australasia pty ltd - selumetinib sulfate, quantity: 12.1 mg (equivalent: selumetinib, qty 10 mg) - capsule, hard - excipient ingredients: titanium dioxide; carnauba wax; potassium chloride; iron oxide black; tocofersolan; strong ammonia solution; shellac; propylene glycol; purified water; carrageenan; hypromellose - koselugo is indicated for the treatment of paediatric patients aged 2 years and above, with neurofibromatosis type 1 (nf1) who have symptomatic, inoperable plexiform neurofibromas (pn).

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

alexion pharmaceuticals inc. - danicopan (unii: jm8c1sfx0u) (danicopan - unii:jm8c1sfx0u) - voydeya is indicated as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (evh) in adults with paroxysmal nocturnal hemoglobinuria (pnh). limitations of use voydeya has not been shown to be effective as monotherapy and should only be prescribed as an add-on to ravulizumab or eculizumab. voydeya is contraindicated for initiation in patients with unresolved serious infection caused by encapsulated bacteria, including neisseria meningitidis , streptococcus pneumoniae , or haemophilus influenzae type b [see warnings and precautions (5.1)] . risk summary there are no available data on voydeya use in pregnant individuals to evaluate for a drug-associated risk of major birth defects, miscarriage or 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 voydeya 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 danicopan to pregnant new zealand white (nzw) rabbits and wistar hans (wh) rats during organogenesis at exposures 18 or 25-times, respectively, above the human exposure at the maximum recommended human dose (mrhd) of 200 mg three times a day (based on auc) resulted in no adverse developmental effects (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 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 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or fetal/neonatal risk pnh in pregnancy is associated with adverse maternal outcomes, including worsening cytopenias, thrombotic events, infections, bleeding, miscarriages, and increased maternal mortality, and adverse fetal outcomes, including fetal death and premature delivery. data animal data there were no effects on early embryonic development and fetal development in nzw rabbits (where danicopan is pharmacodynamically active) up to a mean maternal systemic exposure 18-times the exposure at the mrhd (based on auc) or during post-natal development up to a mean maternal systemic exposure 9-times the exposure at the mrhd (based on auc). in wh rats (where danicopan lacks pharmacodynamic activity), there were no effects on embryo-fetal development up to a mean maternal exposure 25-times the exposure at the mrhd (based on auc). risk summary there are no data on the presence of danicopan in human milk, the effects on the breastfed child, or the effect on milk production. danicopan is present in animal milk. when a drug is present in animal milk, it is likely that the drug will be present in human milk. because of the potential for serious adverse reactions in the breastfed child, including serious infections with encapsulated bacteria and liver enzyme increases, advise patients not to breastfeed during treatment with voydeya, and for 3-days after the last dose. data animal data danicopan was excreted into the milk of lactating rabbits following oral administration from lactation day 4 to lactation day 10, with mean milk concentrations at approximately 2 hours following dose administration 5- and 3.5-times higher than the mean maternal plasma concentrations at 50 and 250 mg/kg/day, respectively. mean milk concentrations in dams were 19- and 43-times higher than the systemic exposure at the mrhd (based on rabbit concentration at 2 hours vs. human cmax ). safety and effectiveness of voydeya for the treatment of pnh in pediatric patients have not been established. there were 22 patients 65 years of age and older in the clinical studies for pnh [see clinical studies (14)] . of the total number of voydeya-treated patients in these studies, 16 (28.1%) were 65 years of age and older, and 7 (12.3%) were 75 years of age and older. clinical studies of voydeya did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. no dose adjustment is required in patients with mild to moderate hepatic impairment (child-pugh class a and b). studies have not been conducted in patients with severe hepatic impairment, therefore, avoid use of voydeya in this patient population [see warnings and precautions (5.3)] .

Նոր Զելանդիա - անգլերեն - Medsafe (Medicines Safety Authority)

max health limited - rocuronium bromide 10 mg/ml;   - solution for injection - 10 mg/ml - active: rocuronium bromide 10 mg/ml   excipient: glacial acetic acid sodium acetate trihydrate sodium chloride water for injection - rocuronium is indicated as an adjunct to general anaesthesia to facilitate endotracheal intubation during routine induction, to provide muscle relaxation and to facilitate mechanical ventilation in adults, and paediatric patients from term newborn infants to adolescents. in adults, rocuronium is also indicated as an adjunct to general anaesthesia to facilitate endotracheal intubation during rapid sequence induction when suxamethonium is contraindicated. in adults, rocuronium is also indicated as an adjunct in the intensive care unit (icu) to facilitate mechanical ventilation.

Նոր Զելանդիա - անգլերեն - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - rocuronium bromide 10mg - solution for injection - 10 mg/ml - active: rocuronium bromide 10mg excipient: acetic acid sodium acetate trihydrate sodium chloride sodium hydroxide water for injection - as an adjunct to general anaesthesia to facilitate tracheal intubation during routine induction, and during rapid sequence induction when suxamethonium is contraindicated