European Union - English - EMA (European Medicines Agency)

astrazeneca ab - anifrolumab - lupus erythematosus, systemic - immunosuppressants - saphnelo is indicated as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (sle), despite standard therapy.,

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

astrazeneca pharmaceuticals lp - anifrolumab (unii: 38rl9ae51q) (anifrolumab - unii:38rl9ae51q) - saphnelo (anifrolumab-fnia) is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (sle), who are receiving standard therapy [see clinical studies (14)] . limitations of use the efficacy of saphnelo has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. use of saphnelo is not recommended in these situations.                                                                 saphnelo is contraindicated in patients with a history of anaphylaxis with anifrolumab-fnia [see warnings and precautions (5.2)] . pregnancy exposure registry a pregnancy exposure registry monitors pregnancy outcomes in women exposed to saphnelo during pregnancy. for more information about the registry or to report a pregnancy while on saphnelo, contact astrazeneca at 1‑877‑693‑9268. risk summary the limited human data with saphnelo use in pregnant women are insufficient to inform on drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcome. monoclonal igg antibodies are known to be actively transported across the placenta as pregnancy progresses; therefore, anifrolumab-fnia exposure to the fetus may be greater during the third trimester of pregnancy. in an enhanced pre- and post-natal development study with pregnant cynomolgus monkeys that received intravenous administration of anifrolumab-fnia, there was no evidence of embryotoxicity or fetal malformations with exposures up to approximately 28‑times the exposure at the maximum recommended human dose (mrhd) on an area under curve (auc) basis (see data) . all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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. clinical considerations disease-associated maternal and/or embryo/fetal risk : pregnant women with sle are at increased risk of adverse pregnancy outcomes, including worsening of the underlying disease, premature birth, miscarriage, and intrauterine growth restriction. maternal lupus nephritis increases the risk of hypertension and preeclampsia/eclampsia. passage of maternal autoantibodies across the placenta may result in adverse neonatal outcomes, including neonatal lupus and congenital heart block. data animal data : in an enhanced pre- and post-natal development study, pregnant cynomolgus monkeys received anifrolumab-fnia at intravenous doses of 30 or 60 mg/kg once every 2 weeks from confirmation of pregnancy at gestation day 20, throughout the gestation period, and continuing until 1‑month post-partum (approximately lactation day 28). there was no evidence of anifrolumab-fnia related maternal toxicity, embryo-fetal toxicity, or post-natal developmental effects. no anifrolumab-fnia related effect on t-cell-dependent antibody response in the infants was noted up to day 180 after birth. the no observed adverse effect level (noael) for maternal and developmental toxicity was identified as 60 mg/kg (approximately 28‑times the mrhd on an auc basis). in the infants, mean serum concentrations of anifrolumab‑fnia on day 30 after birth increased with dose and were approximately 4.2% to 9.7% of the respective maternal concentrations. the anifrolumab-fnia concentrations in the infant serum were up to approximately 22‑times the concentrations in the maternal milk, suggesting that anifrolumab-fnia had transferred via the placenta. risk summary no data are available regarding the presence of saphnelo in human milk, the effects on the breastfed child, or the effects on milk production. anifrolumab-fnia was detected in the milk of female cynomolgus monkeys administered anifrolumab-fnia. due to species-species differences in lactation physiology, animal data may not reliably predict drug levels in humans. maternal igg is known to be present in human milk. if anifrolumab-fnia is transferred into human milk, the effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to anifrolumab-fnia are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for anifrolumab-fnia and any potential adverse effects on the breast-fed child from anifrolumab-fnia or from the underlying maternal condition. the safety and efficacy of saphnelo in pediatric patients less than 18 years of age have not been established. of the 664 patients with sle exposed to anifrolumab-fnia in clinical trials, 3% (n=20) were 65 and over. the number of patients aged 65 years of age and older was not sufficient to determine whether they respond differently from younger adult patients.

Israel - English - Ministry of Health

astrazeneca (israel) ltd - anifrolumab - concentrate for solution for infusion - anifrolumab 150 mg/ml - anifrolumab - saphnelo is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (sle), who are receiving standard therapy.limitations of usethe efficacy of saphnelo has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. use of saphnelo is not recommended in these situations.

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

skin technology limited - picaridin - liquid - picaridin piperidine active 191.0 g/l - household insecticide - pest control - personal use - biting insect | fly | mosquito | sand fly (biting midge) | tick | adult mosquitoes

Canada - English - Health Canada

astrazeneca canada inc - anifrolumab - solution - 150mg - anifrolumab 150mg

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

astrazeneca sdn. bhd. - anifrolumab -

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

lusio technologies pty ltd - 47518 - patient rehabilitation interactive software - the device is intended to motivate individuals to perform habilitation or rehabilitation exercises ?physio? through the medium of video games. the hardware can be strapped to any part of the body that requires physio by attaching velcro straps to secure the device. once attached the user can select the game, which aligns to their specific physio need and start playing.

Canada - English - Health Canada

the avon company canada limited - homosalate; octinoxate; oxybenzone; octisalate; avobenzone - lotion - 8.0%; 7.5%; 6.0%; 5.0%; 3.0% - homosalate 8.0%; octinoxate 7.5%; oxybenzone 6.0%; octisalate 5.0%; avobenzone 3.0% - sunscreen agents

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

agnova technologies pty ltd - cyflufenamid - emulsion - oil in water - cyflufenamid amide active 50.0 g/l - fungicide - cucurbit | grapevine | cantaloupe | choko | cucumber | gherkin | honeydew melon | marrow | melon | muskmelon | pumpkin | rockmel - powdery mildew

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

syngenta australia pty ltd - lambda-cyhalothrin - capsule suspension - lambda-cyhalothrin pyrethroid active 0.5 g/l - insecticide - pest control - american cockroach | ant | cat flea | fly | german cockroach | mosquito | silverfish | spider | adult mosquitoes | argentine ant | pharaoh ant