Malezija - angleščina - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

gilead sciences malaysia sdn. bhd. - remdesivir -

Evropska unija - angleščina - EMA (European Medicines Agency)

gilead sciences ireland uc - remdesivir - covid-19 virus infection - veklury is indicated for the treatment of coronavirus disease 2019 (covid 19) in:adults and paediatric patients (at least 4 weeks of age and weighing at least 3 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment)adults and paediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and who are at increased risk of progressing to severe covid-19

Malta - angleščina - Medicines Authority

remedica limited limassol industrial estate, aharnon street, 3056 limassol, cyprus - hyoscine butylbromide - coated tablet - hyoscine butylbromide 10 mg - drugs for functional gastrointestinal disorders

Kanada - angleščina - Health Canada

gilead sciences canada inc - remdesivir - solution - 100mg - remdesivir 100mg - nucleosides and nucleotides

Kanada - angleščina - Health Canada

gilead sciences canada inc - remdesivir - powder for solution - 100mg - remdesivir 100mg - nucleosides and nucleotides

Združene države Amerike - angleščina - NLM (National Library of Medicine)

gilead sciences, inc. - remdesivir (unii: 3qki37eehe) (remdesivir - unii:3qki37eehe) - veklury is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults and pediatric patients (birth to less than 18 years of age weighing at least 1.5 kg) who are [see clinical studies (14)] : - hospitalized, or - not hospitalized and have mild-to-moderate covid-19, and are at high risk for progression to severe covid-19, including hospitalization or death. veklury is contraindicated in patients with a history of clinically significant hypersensitivity reactions to veklury or any components of the product [see warnings and precautions (5.1)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to veklury during pregnancy. pregnant and recently pregnant individuals can go to https://covid-pr.pregistry.com to enroll or call 1-800-616-3791 to obtain information about the registry. risk summary available data from a clinical trial (impaact 2032), published reports, the ongoing covid-pr pregnancy exposure registry, and compassionate use of remdesivir in pregnant individuals have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes following exposure in the second and third trimester. however, there are insufficient pregnancy data available to evaluate the risk of remdesivir exposure during the first trimester. a study evaluating the pharmacokinetics of remdesivir during pregnancy demonstrated no clinically relevant differences between pregnant and non-pregnant individuals. no dose adjustments are recommended in patients who receive veklury during pregnancy (see data) and [see clinical pharmacology (12.3)] . in nonclinical reproductive toxicity studies, remdesivir demonstrated no adverse effect on embryo-fetal development when administered to pregnant animals at systemic exposures (auc) of the predominant circulating metabolite of remdesivir (gs-441524) that were 4 times (rats and rabbits) the exposure in humans at the recommended human dose (rhd) (see data). there are maternal and fetal risks associated with untreated covid-19 in pregnancy (see clinical considerations). the 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. clinical considerations disease-associated maternal and/or embryo-fetal risk covid-19 in pregnancy is associated with adverse maternal and fetal outcomes, including preeclampsia, eclampsia, preterm birth, premature rupture of membranes, venous thromboembolic disease, and fetal death. data human data a non-randomized, open-label clinical study (impaact 2032) evaluated pharmacokinetics and safety of up to 10 days of treatment with veklury in 25 hospitalized pregnant and 28 hospitalized non-pregnant individuals of childbearing potential. subjects received veklury 200 mg once daily for 1 day followed by veklury 100 mg once daily on subsequent days via intravenous infusion. subjects were enrolled prior to their fourth veklury infusion. assessments occurred at the following intervals: screening; pre-infusion (defined as 48 hours prior to start of first infusion); each infusion day; 48 hours after the last infusion; 7 days after the last infusion; 4 weeks after the last infusion. assessments also occurred 24 hours post-delivery in subjects who delivered. treatment with veklury was stopped in subjects who were discharged from the hospital prior to the completion of 10 days of treatment. of the 25 pregnant subjects, median age was 33 years (q1, q3: 27 years, 37 years); 40% were white, 24% were black, and 48% were hispanic or latino. a total of 9 subjects (36%) were on high-flow oxygen; 12 subjects (48%) were on low-flow oxygen; and 1 subject (4%) was on room air, at baseline. three subjects (12%) did not have data available on baseline oxygen status. the overall median (q1, q3) duration of symptoms prior to hospitalization was 7 (6, 9) days. the overall median (q1, q3) duration of symptoms prior to first dose of veklury was 8 (6, 9) days. of the 25 pregnant subjects, median gestational age was 28 weeks at baseline (range 22 to 33 weeks) and about half of subjects were in each of the second and third trimester of pregnancy. no clinically relevant differences in the pharmacokinetics of remdesivir or its metabolites (gs-704277 and gs-441524) were observed between pregnant (n=21) and non-pregnant (n=22) individuals [see clinical pharmacology (12.3)] . no difference in pharmacokinetics of remdesivir or its metabolites is expected between the first and second/third trimesters. the adverse reactions observed were consistent with those observed in clinical trials of veklury in adults [see adverse reactions (6.1)] . there were no adverse reactions in infants born during the study (n=16). animal data remdesivir was administered via intravenous injection to pregnant rats and rabbits (up to 20 mg/kg/day) on gestation days 6 through 17, and 7 through 20, respectively, and also to rats from gestation day 6 to lactation/post-partum day 20. no adverse effects on embryo-fetal (rats and rabbits) or pre/postnatal (rats) development were observed in rats and rabbits at nontoxic doses in pregnant animals. during organogenesis, exposures to the predominant circulating metabolite (gs-441524) were 4 times higher (rats and rabbits) than the exposure in humans at the rhd. in a pre/postnatal development study, exposures to the predominant circulating metabolite of remdesivir (gs-441524) were similar to the human exposures at the rhd. risk summary a published case report describes the presence of remdesivir and active metabolite gs-441524 in human milk. available data (n=11) from pharmacovigilance reports do not indicate adverse effects on breastfed infants from exposure to remdesivir and its metabolite through breastmilk. there are no available data on the effects of remdesivir on milk production. in animal studies, remdesivir and metabolites have been detected in the nursing pups of mothers given remdesivir, likely due to the presence of remdesivir in milk (see data). the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for veklury and any potential adverse effects on the breastfed child from veklury or from the underlying maternal condition. breastfeeding individuals with covid-19 should follow practices according to clinical guidelines to avoid exposing the infant to covid-19. data remdesivir and its metabolites were detected in the plasma of nursing rat pups, likely due to the presence of remdesivir and/or its metabolites in milk, following daily intravenous administration of remdesivir to pregnant rats from gestation day 6 to lactation day 20. exposures in nursing pups were approximately 1% that of maternal exposure on lactation day 10. the concentration of remdesivir in animal milk does not necessarily predict the concentration of drug in human milk. the safety and effectiveness of veklury for the treatment of covid-19 have been established in pediatric patients from birth to less than 18 years of age and weighing at least 1.5 kg, who are: - hospitalized, or - not hospitalized and have mild-to-moderate covid-19, and are at high risk for progression to severe covid-19, including hospitalization or death. use in this age group is supported by the following: - trials in adults [see clinical studies (14.1, 14.2, 14.3, 14.4, 14.5)] - an open-label trial (study 5823) in 58 hospitalized pediatric subjects [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14.6)]. use of veklury in pediatric patients from birth to less than 18 years of age and weighing at least 1.5 kg is supported by study 5823 where 58 hospitalized pediatric subjects were treated with weight-based veklury for up to 10 days in the following cohorts: - cohorts 1–4, 8; infants, children, and adolescents: subjects ≥12 years and weighing ≥40 kg (n=12); subjects <12 years and weighing ≥40 kg (n=5); subjects ≥28 days and weighing ≥20 to <40 kg (n=12); subjects ≥28 days and weighing ≥12 to <20 kg (n=12); and subjects ≥28 days and weighing ≥3 to <12 kg (n=12); - cohorts 5–7; neonates and infants: subjects 14 to <28 days old, ga >37 weeks, and weighing ≥2.5 kg (n=3); subjects <14 days old, ga >37 weeks, and weighing ≥2.5 kg at birth (n=1); and subjects <56 days old, ga ≤37 weeks, and weighing ≥1.5 kg at birth (n=1). the safety and pharmacokinetic results in pediatric subjects were similar to those in adults [see adverse reactions (6.1), clinical pharmacology (12.3), clinical studies (14.6)]. use of veklury in pediatric patients weighing at least 40 kg is further supported by a clinical trial of veklury in non-hospitalized subjects that included 3 pediatric subjects 12 years and older, and by clinical trials in hospitalized subjects that included 30 adult subjects weighing 40 to 50 kg. the safety in this weight group was comparable to adult subjects weighing greater than 50 kg. thirty-nine pediatric patients 12 years and older and weighing at least 40 kg received veklury in a compassionate use program in hospitalized subjects; the available clinical data from these patients are limited [see adverse reactions (6.1) and clinical studies (14)]. use of veklury in pediatric patients with renal impairment is supported by safety data in adults [see adverse reactions (6.1), use in specific populations (8.6)]. limited data are available regarding the safety of veklury in pediatric patients with mild or moderate renal impairment. no data are available regarding the safety of veklury in pediatric patients with severe renal impairment. in adults with severe renal impairment, including those requiring dialysis, exposures of gs-441524 and gs-704277, the metabolites of remdesivir, and betadex sulfobutyl ether sodium (sbecd) are increased [see clinical pharmacology (12.3)] . veklury contains sbecd which, when administered intravenously, is eliminated through glomerular filtration and therefore when administered to pediatric patients with renal immaturity or renal impairment, may result in higher exposure to sbecd. the safety and effectiveness of veklury have not been established in pediatric patients weighing less than 1.5 kg. of the 1,062 hospitalized subjects with sars-cov-2 infection randomized in actt-1, 36% were 65 years or older. of the 397 hospitalized subjects with sars-cov-2 infection randomized in study gs-us-540-5773, 42% were 65 years or older. of the 584 hospitalized subjects with sars-cov-2 infection randomized in study gs-us-540-5774, 27% were 65 years or older. of the 562 non-hospitalized subjects with sars-cov-2 infection randomized in study gs-us-540-9012, 17% were 65 years or older. reported clinical experience has not identified differences in responses between the elderly and younger patients [see clinical studies (14)] . no dosage adjustment is required in patients over the age of 65 years. in general, appropriate caution should be exercised in the administration of veklury and monitoring of elderly patients, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. use of veklury in patients with covid-19 and renal impairment, including those on dialysis, is supported by safety and pharmacokinetic data from the following: - a randomized, double-blind, placebo-controlled trial (study 5912) in adults [see adverse reactions (6.1) and clinical pharmacology (12.3)]. - an open-label, parallel-group, single-dose trial in subjects with normal renal function and renal impairment (study 9015) [see clinical pharmacology (12.3)]. the pharmacokinetics and safety of veklury in patients with covid-19 and renal impairment, including those on dialysis, were evaluated in 163 subjects in a randomized, double-blind, placebo-controlled trial, study gs-us-540-5912 [see adverse reactions (6.1) and clinical pharmacology (12.3)]. study gs-us-540-5912 evaluated veklury 200 mg once daily for 1 day followed by veklury 100 mg once daily for 4 days (for a total of up to 5 days of intravenously administered therapy) in 243 hospitalized adult subjects with confirmed covid-19 and renal impairment. the trial included 90 subjects (37%) with aki (defined as a 50% increase in serum creatinine within a 48-hour period that was sustained for ≥6 hours despite supportive care), 64 subjects (26%) with ckd (egfr <30 ml/minute/1.73m2 ), and 89 subjects (37%) with esrd (egfr <15 ml/minute/1.73m2 ) requiring hemodialysis. subjects were randomized in a 2:1 manner, stratified by esrd, high-flow oxygen requirement, and region (us vs ex-us) to receive veklury (n=163) or placebo (n=80), plus standard of care. at baseline, mean age was 69 years (with 62% of subjects aged 65 or older); 57% of subjects were male, 67% were white, 26% were black, and 3% were asian. the most common baseline risk factors were hypertension (89%), diabetes mellitus (79%), and cardiovascular or cerebrovascular disease (51%); the distribution of risk factors was similar between the two treatment groups. a total of 45 subjects (19%) were on high-flow oxygen, 144 (59%) were on low-flow oxygen, and 54 (22%) were on room air at baseline; no subjects were on invasive mechanical ventilation (imv). a total of 182 subjects (75%) were not on renal replacement therapy, and 31 subjects (13%) had received a covid-19 vaccine. the safety results in subjects with covid-19 and renal impairment, including those on dialysis, were consistent with those observed in clinical trials of veklury in adults [see adverse reactions (6.1)]. study gs-us-540-5912 closed prematurely due to feasibility issues and was underpowered to assess for efficacy because of lower than expected enrollment. the pharmacokinetics and safety of veklury in subjects with normal renal function and renal impairment, including those on dialysis, were evaluated in 75 subjects (43 subjects with renal impairment plus 32 matched control subjects with normal renal function) in an open-label, parallel-group, single-dose trial, study gs-us-540-9015 [see clinical pharmacology (12.3)]. in studies gs-us-540-5912 and gs-us-540-9015, exposures of gs-441524 and gs-704277, the metabolites of remdesivir, and sbecd are increased in subjects with mild to severe renal impairment, including those requiring dialysis, relative to subjects with normal renal function [see clinical pharmacology (12.3)] . no dosage adjustment of veklury is recommended for patients with any degree of renal impairment, including those on dialysis [see dosage and administration (2.2, 2.4), use in specific populations (8.4)]. no dosage adjustment of veklury is recommended for patients with mild, moderate, or severe hepatic impairment (child-pugh class a, b, or c) [see clinical pharmacology (12.3)] . perform hepatic laboratory testing in all patients before starting veklury and while receiving veklury as clinically appropriate [see dosage and administration (2.2) and warnings and precautions (5.2)].

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

gilead sciences pty ltd - remdesivir, quantity: 100 mg - injection, powder for - excipient ingredients: sulfobutyl betadex sodium; sodium hydroxide; hydrochloric acid - veklury has provisional approval for the treatment of coronavirus disease 2019 (covid-19) in:,- adults and paediatric patients (at least 4 weeks of age and weighing at least 3 kg) who have pneumonia due to sars-cov-2, and who require supplemental oxygen.,- adults and paediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and who are at high risk of progressing to severe covid-19.,the decision to approve this medicine has been made based on limited data. more comprehensive evidence is required to be submitted.

Izrael - angleščina - Ministry of Health

gilead sciences israel ltd - remdesivir - powder for concentrate for solution for infusion - remdesivir 100 mg/vial - veklury is indicated for the treatment of coronavirus disease 2019 (covid-19) -in adults and pediatric patients (at least 4 weeks of age and weighing at least 3 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment).-adults who do not require supplemental oxygen and who are at increased risk of progressing to severe covid-19

Armenija - angleščina - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

m/s. aspiro pharma limited - remdesivir - powder lyophilized for solution for infusion - 100mg

Združene države Amerike - angleščina - NLM (National Library of Medicine)

gilead sciences, inc. - remdesivir (unii: 3qki37eehe) (remdesivir - unii:3qki37eehe) - the u.s. food and drug administration (fda) has issued an emergency use authorization (eua) to permit the emergency use of veklury for the treatment of coronavirus disease 2019 (covid-19) in pediatric patients weighing 3.5 kg to less than 40 kg or pediatric patients less than 12 years of age weighing at least 3.5 kg, with positive results of direct severe acute respiratory syndrome coronavirus 2 (sars-cov-2) viral testing, who are: - hospitalized, or - not hospitalized and have mild-to-moderate covid-19, and are at high risk for progression to severe covid-19, including hospitalization or death. refer to cdc website1 for additional details. veklury has been authorized by fda for the emergency uses described above. veklury is not fda-approved for these uses. veklury is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of veklury under section 564(b)(1) of the act, 21 u.s.c. § 360bbb-3(b)(1), unless the authorization is terminated or