Canada - English - Health Canada

eugia pharma inc. - vancomycin (vancomycin hydrochloride) - powder for solution - 5g - vancomycin (vancomycin hydrochloride) 5g

Canada - English - Health Canada

mitsubishi tanabe pharma corporation - edaravone - solution - 30mg - edaravone 30mg - miscellaneous central nervous system agents

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

mitsubishi tanabe pharma malaysia sdn. bhd. - edaravone -

Canada - English - Health Canada

amylyx pharmaceuticals inc. - sodium phenylbutyrate; ursodoxicoltaurine - powder for suspension - 3g; 1g - sodium phenylbutyrate 3g; ursodoxicoltaurine 1g

United States - English - NLM (National Library of Medicine)

amylyx pharmaceuticals inc - sodium phenylbutyrate (unii: nt6k61736t) (phenylbutyric acid - unii:7wy7ybi87e), taurursodiol dihydrate (unii: u7xrv7rz1i) (taurursodiol - unii:60eux8mn5x) - relyvrio is indicated for the treatment of amyotrophic lateral sclerosis (als) in adults. none. risk summary there are no available data on relyvrio use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. in animal studies, administration of sodium phenylbutyrate and taurursodiol to rats throughout pregnancy and lactation resulted in increased offspring mortality at all doses tested, which were less than or similar to the clinical doses. 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% to 4% and 15% to 20%, respectively. data animal data oral administration of the combination of sodium phenylbutyrate and taurursodiol (0, 375, 750, or 1500 mg/kg/day, containing sodium phenylbutyrate and taurursodiol in a 3:1 ratio) to pregnant mice during the period of organogenesis was not associated with any adverse effects. at the highest dose of the combination of sodium phenylbutyrate and taurursodiol tested, the doses of sodium phenylbutyrate and taurursodiol were similar to the maximum recommended dose (6 g sodium phenylbutyrate and 2 g taurursodiol) in humans (mrhds), based on body surface area (mg/m2 ). oral administration of the combination of sodium phenylbutyrate and taurursodiol (0, 375, 750, or 1500 mg/kg/day) to pregnant rats during the period of organogenesis was not associated with any adverse effects. at the highest dose of the combination of sodium phenylbutyrate and taurursodiol tested, the doses of sodium phenylbutyrate and taurursodiol were approximately 2-fold the mrhds, based on mg/m2 . oral administration of the combination of sodium phenylbutyrate and taurursodiol (0, 375, 750, or 1500 mg/kg/day) to rats throughout pregnancy and lactation resulted in increases in stillbirth at all doses and pup deaths at the highest dose tested. a no effect dose for adverse developmental effects in rats was not identified. at the lowest dose of the combination of sodium phenylbutyrate and taurursodiol tested, the doses of sodium phenylbutyrate and taurursodiol were less than the mrhds, based on mg/m2 . risk summary there are no data on the presence of sodium phenylbutyrate or taurursodiol in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for relyvrio and any potential adverse effects on the breastfed child from relyvrio or from the underlying maternal condition. safety and effectiveness of relyvrio in pediatric patients have not been established. of the 89 patients with als who received relyvrio in study 1, 25 patients (28%) were 65 years of age or older, while 4 patients (4.5%) were 75 years of age and older with the oldest patient being 79 years old. no overall differences in safety or effectiveness were observed between those patients 65 years of age and older and those <65 years of age.  although differences in responses between the elderly and younger patients were not identified, greater sensitivity of some older individuals cannot be ruled out. no dose adjustment is needed for patients with mild renal impairment. avoid use in patients with moderate or severe renal impairment [see clinical pharmacology (12.3)] . no dose adjustment is needed for patients with mild hepatic impairment. avoid use in patients with moderate or severe hepatic impairment [see clinical pharmacology (12.3)] .

Canada - English - Health Canada

mitsubishi tanabe pharma corporation - edaravone - suspension - 105mg - edaravone 105mg

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

mitsubishi tanabe pharma malaysia sdn. bhd. - edaravone -

Ireland - English - HPRA (Health Products Regulatory Authority)

bracco uk limited - barium sulfate - powder for rectal suspension - 94 %w/w

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

abbvie pty ltd - ritonavir; lopinavir -

New Zealand - English - Medsafe (Medicines Safety Authority)

aft pharmaceuticals ltd - cefotaxime sodium 1048.1mg equivalent 1 g cefotaxime (+ 5% overage) - powder for injection - 1 g - active: cefotaxime sodium 1048.1mg equivalent 1 g cefotaxime (+ 5% overage) - cefotaxime is indicated in the treatment of the following infections either before the infecting organism has been identified or when caused by bacteria of established sensitivity. · septicaemia. · respiratory tract infections: acute and chronic bronchitis, bacterial pneumonia, infected bronchiectasis, lung abscess and post-operative chest infections. · urinary tract infections: acute and chronic pyelonephritis, cystitis and asymptomatic bacteriuria. · soft tissue infections: cellulitis, peritonitis and wound infections. · bone and joint infections: osteomyelitis, septic arthritis. · obstetric and gynaecological infections: pelvic inflammatory disease. · gonorrhoea: particularly if penicillin-resistant. · other bacterial infections: meningitis and other sensitive infections suitable for parenteral antibiotic therapy. the administration of cefotaxime prophylactically may reduce the incidence of certain post-operative infections in patients undergoing surgical procedures that are classified as contaminated or potentially contaminated or in clean operations where infections would have serious effects. protection is best ensured by achieving adequate local tissue concentrations at the time contamination is likely to occur. cefotaxime should therefore be administered immediately prior to surgery and if necessary continued in the immediate post-operative period. administration should usually be stopped within 24 hours since continuing use of any antibiotic in the majority of surgical procedures does not reduce the incidence of subsequent infections.