Tsjekkia - tsjekkisk - SUKL (Státní ústav pro kontrolu léčiv)

neuraxpharm bohemia s.r.o., praha array - 10792 fluoxetin-hydrochlorid - tvrdá tobolka - 20mg - fluoxetin

Den europeiske union - kroatisk - EMA (European Medicines Agency)

roche registration gmbh - baloxavir marboxil - gripa, ljudska - antivirusni lijekovi za sustavnu uporabu - treatment of influenzaxofluza is indicated for the treatment of uncomplicated influenza in patients aged 1 year and above. post exposure prophylaxis of influenzaxofluza is indicated for post-exposure prophylaxis of influenza in individuals aged 1 year and above. xofluza should be used in accordance with official recommendations.

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

roche products pty ltd - baloxavir marboxil, quantity: 80 mg - tablet, film coated - excipient ingredients: lactose monohydrate; croscarmellose sodium; microcrystalline cellulose; povidone; sodium stearylfumarate; purified talc; hypromellose; titanium dioxide - treatment of influenza,xofluza is indicated for the treatment of uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours and who are:,? otherwise healthy, or,? at high risk of developing influenza complications.,prophylaxis of influenza,xofluza is indicated for the post-exposure prophylaxis of influenza in patients aged 12 years of age and older following contact with an individual who has confirmed influenza.,vaccination is the preferred method of routine prophylaxis against infection with influenza virus.

USA - engelsk - NLM (National Library of Medicine)

genentech, inc. - baloxavir marboxil (unii: 505cxm6ohg) (baloxavir - unii:4g86y4jt3f) - xofluza is indicated for treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications1 [see clinical studies (14)]. xofluza is indicated for post-exposure prophylaxis of influenza in persons 5 years of age and older following contact with an individual who has influenza [see clinical studies (14.4)]. influenza viruses change over time, and factors such as the virus type or subtype, emergence of resistance, or changes in viral virulence could diminish the clinical benefit of antiviral drugs. consider available information on drug susceptibility patterns for circulating influenza virus strains when deciding whether to use xofluza [see warnings and precautions (5.2), microbiology (12.4) and clinical studies (14)] . xofluza is contraindicated in patients with a history of hypersensitivity to baloxavir marboxil or any of its ingredients. serious allergic reactions have included anaphylaxis, angioedema, urticaria, and erythema multiforme [see warnings and precautions (5.1)]. risk summary there are no adequate and well-controlled studies with xofluza in pregnant women to inform a drug-associated risk of adverse developmental outcomes. there are risks to the mother and fetus associated with influenza virus infection in pregnancy (see clinical considerations). in animal reproduction studies, no adverse developmental effects were observed in rats or rabbits with oral administration of baloxavir marboxil at exposures approximately 5 (rats) and 7 (rabbits) times the systemic baloxavir exposure at the maximum recommended human dose (mrhd) (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 defects, 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 embryo/fetal risk pregnant women are at higher risk of severe complications from influenza, which may lead to adverse pregnancy and/or fetal outcomes, including maternal death, stillbirth, birth defects, preterm delivery, low birth weight, and small for gestational age. data animal data baloxavir marboxil was administered orally to pregnant rats (20, 200, or 1,000 mg/kg/day from gestation day 6 to 17) and rabbits (30, 100, or 1,000 mg/kg/day from gestation day 7 to 19). no adverse embryo-fetal effects were observed in rats up to the highest dose of baloxavir marboxil (1,000 mg/kg/day), resulting in systemic baloxavir exposure (auc) of approximately 5 times the exposure at the mrhd. in rabbits, fetal skeletal variations occurred at a maternally toxic dose (1,000 mg/kg/day) resulting in 2 abortions out of 19 pregnancies. no adverse maternal or embryo-fetal effects were observed in rabbits at the middle dose (100 mg/kg/day) resulting in systemic baloxavir exposure (auc) approximately 7 times the exposure at the mrhd. in the prenatal and postnatal development study in rats, baloxavir marboxil was administered orally at 20, 200, or 1,000 mg/kg/day from gestation day 6 to postpartum/lactation day 20. no significant effects were observed in the offspring at maternal systemic baloxavir exposure (auc) approximately 5 times the exposure at the mrhd. risk summary there are no data on the presence of baloxavir marboxil in human milk, the effects on the breastfed infant, or the effects on milk production. baloxavir and its related metabolites were present in the milk of lactating rats (see data) . the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for xofluza and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition. data in a lactation study, baloxavir and its related metabolites were excreted in the milk of lactating rats administered baloxavir marboxil (1 mg/kg) on postpartum/lactation day 11, with peak milk concentration approximately 5 times that of maternal plasma concentrations occurring 2 hours post-dose. no effects of baloxavir marboxil on growth and postnatal development were observed in nursing pups at the highest oral dose tested in rats. maternal systemic exposure was approximately 5 times the baloxavir exposure in humans at the mrhd. treatment of acute uncomplicated influenza in adolescent subjects (≥ 12 years of age) the safety and effectiveness of xofluza for the treatment of acute uncomplicated influenza in adolescent subjects 12 years of age and older weighing at least 40 kg is supported by one randomized, double-blind, controlled trial in otherwise healthy subjects trial t0831 and one trial in subjects at high risk of developing influenza-related complications trial t0832 [see clinical studies (14.1)]. a total of 117 otherwise healthy adolescents 12 to17 years of age were randomized and received either xofluza (n=76) or placebo (n=41) in trial t0831; 38 adolescents 12 to 17 years of age at high risk for influenza complications were randomized and received either xofluza (n=21) or placebo (n=17) in trial t0832. the median time to alleviation of symptoms in influenza-infected adolescent subjects aged 12 to 17 years in trial t0831 was comparable to that observed in adults. in trial t0832, the median time to improvement of symptoms in the limited number of influenza-infected adolescent subjects aged 12 to 17 years was similar in the xofluza and placebo arms [see clinical studies (14.1)]. adverse events reported in adolescents in both trials were similar to those reported in adults [see adverse reactions (6.1)]. treatment of acute uncomplicated influenza in pediatric subjects (5 to < 12 years of age) the safety and effectiveness of xofluza in pediatric subjects 5 to less than 12 years of age is supported by one randomized, double-blind, controlled trial trial cp40563 with a primary endpoint of safety. in this trial, 118 pediatric subjects were randomized and treated in a 2:1 ratio and received either xofluza (n=79) or oseltamivir (n=39). efficacy was extrapolated from adults and adolescents based on comparable pk exposures in adults, adolescents and pediatric subjects 5 to less than 12 years of age. the median time to alleviation of signs and symptoms in influenza-infected subjects was comparable in the xofluza and oseltamivir arms. adverse events reported with xofluza in pediatric subjects were similar to those observed in adults and adolescents except for vomiting and diarrhea, which were both more commonly reported in pediatric subjects [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14.1)]. post-exposure prophylaxis of influenza in pediatric and adolescent subjects (5 to < 18 years of age) the safety and effectiveness of xofluza for post-exposure prophylaxis in pediatric and adolescent subjects 5 to less than 18 years of age is supported by one randomized, double-blind, controlled trial conducted in japan trial t0834 [see clinical studies (14.3)]. subjects in this trial were randomized in a 1:1 ratio to receive xofluza or placebo. a total of 69 subjects from 5 to <18 years of age in trial t0834 received xofluza. the incidence of rt-pcr-confirmed symptomatic influenza in pediatric subjects 5 to <18 years of age was similar to that observed in adult subjects [see clinical pharmacology (12.3), and clinical studies (14.3)]. efficacy was extrapolated from adults based on comparable pk exposures in adults, adolescents and pediatric subjects 5 to <18 years of age. adverse events reported in pediatric and adolescent subjects were similar to those reported in adults in the same trial [see adverse reactions (6.1)]. pediatric subjects (< 5 years of age) the safety and effectiveness of xofluza for treatment and post-exposure prophylaxis of influenza in pediatric subjects less than 5 years of age have not been established [see warnings and precautions (5.2) and microbiology (12.4)]. the safety and effectiveness of xofluza in subjects 65 years of age and older has been established and is supported by one randomized, double-blind, controlled trial [see clinical studies (14.2)] . in trial t0832, of 730 xofluza-treated subjects at high risk of influenza-related complications, 209 (29%) subjects were 65 years of age and older. the median time to improvement of influenza symptoms in subjects 65 years of age and older was 70 hours in subjects who received xofluza (n=112) and 88 hours in those who received placebo (n=102). the safety profile observed for this population was similar to that reported in the overall trial population except for nausea, which was reported in 6% of elderly subjects compared to 1% of subjects from 18 to 64 years of age.

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

roche products pty ltd - baloxavir marboxil, quantity: 40 mg - tablet, film coated - excipient ingredients: lactose monohydrate; croscarmellose sodium; microcrystalline cellulose; povidone; sodium stearylfumarate; purified talc; hypromellose; titanium dioxide - treatment of influenza,xofluza is indicated for the treatment of uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours and who are:,? otherwise healthy, or,? at high risk of developing influenza complications.,prophylaxis of influenza,xofluza is indicated for the post-exposure prophylaxis of influenza in patients aged 12 years of age and older following contact with an individual who has confirmed influenza.,vaccination is the preferred method of routine prophylaxis against infection with influenza virus.

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

roche products pty ltd - baloxavir marboxil, quantity: 20 mg - tablet, film coated - excipient ingredients: lactose monohydrate; croscarmellose sodium; microcrystalline cellulose; povidone; sodium stearylfumarate; purified talc; hypromellose; titanium dioxide - treatment of influenza,xofluza is indicated for the treatment of uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours and who are:,? otherwise healthy, or,? at high risk of developing influenza complications.,prophylaxis of influenza,xofluza is indicated for the post-exposure prophylaxis of influenza in patients aged 12 years of age and older following contact with an individual who has confirmed influenza.,vaccination is the preferred method of routine prophylaxis against infection with influenza virus.

Den europeiske union - finsk - EMA (European Medicines Agency)

roche registration gmbh - baloxavir marboxil - influenssa, ihminen - antiviraalit systeemiseen käyttöön - treatment of influenzaxofluza is indicated for the treatment of uncomplicated influenza in patients aged 1 year and above. post exposure prophylaxis of influenzaxofluza is indicated for post-exposure prophylaxis of influenza in individuals aged 1 year and above. xofluza should be used in accordance with official recommendations.

Den europeiske union - maltesisk - EMA (European Medicines Agency)

roche registration gmbh - baloxavir marboxil - influwenza, bniedem - antivirali għal użu sistemiku - treatment of influenzaxofluza is indicated for the treatment of uncomplicated influenza in patients aged 1 year and above. post exposure prophylaxis of influenzaxofluza is indicated for post-exposure prophylaxis of influenza in individuals aged 1 year and above. xofluza should be used in accordance with official recommendations.

Den europeiske union - estisk - EMA (European Medicines Agency)

roche registration gmbh - baloxavir marboxil - gripp, inimene - viirusevastased ravimid süsteemseks kasutamiseks - treatment of influenzaxofluza is indicated for the treatment of uncomplicated influenza in patients aged 1 year and above. post exposure prophylaxis of influenzaxofluza is indicated for post-exposure prophylaxis of influenza in individuals aged 1 year and above. xofluza should be used in accordance with official recommendations.

Den europeiske union - dansk - EMA (European Medicines Agency)

roche registration gmbh - baloxavir marboxil - influenza, human - antivirale midler til systemisk anvendelse - treatment of influenzaxofluza is indicated for the treatment of uncomplicated influenza in patients aged 1 year and above. post exposure prophylaxis of influenzaxofluza is indicated for post-exposure prophylaxis of influenza in individuals aged 1 year and above. xofluza should be used in accordance with official recommendations.