Irlanda - inglês - HPRA (Health Products Regulatory Authority)

d.d.d. limited - docosanol - cream - 100 milligram(s)/gram - antivirals; docosanol

Bélgica - inglês - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

phoenix healthcare - docosanol 10 g/100 g - cream - 10 % - docosanol 100 mg/g - docosanol

Estados Unidos - inglês - NLM (National Library of Medicine)

daiichi sankyo inc. - edoxaban tosylate (unii: 32w99ue810) (edoxaban - unii:ndu3j18apo) - edoxaban 15 mg - savaysa is indicated to reduce the risk of stroke and systemic embolism (se) in patients with nonvalvular atrial fibrillation (nvaf). limitation of use for nvaf savaysa should not be used in patients with crcl > 95 ml/min because of an increased risk of ischemic stroke compared to warfarin [see dosage and administration (2.1), warnings and precautions (5.1) and clinical studies (14.1)] . savaysa is indicated for the treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe) following 5 to 10 days of initial therapy with a parenteral anticoagulant. savaysa is contraindicated in patients with: - active pathological bleeding [see warnings and precautions (5.3) and adverse reactions (6.1)] . risk summary available data about savaysa use in pregnant women are insufficient to determine whether there are drug-associated risks for adverse developmental outcomes. in animal developmental studies, no adverse developmental effects were seen when edoxaban was administered orally to pregnant rats and rabbits during organogenesis at up to 16-times and 8-times, respectively, the human exposure, when based on body surface area and auc, respectively (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 embryo/fetal risk pregnancy confers an increased risk of thromboembolism that is higher for women with underlying thromboembolic disease and certain high-risk pregnancy conditions. published data describe that women with a previous history of venous thrombosis are at high risk for recurrence during pregnancy. fetal/neonatal adverse reactions use of anticoagulants, including edoxaban, may increase the risk of bleeding in the fetus and neonate. monitor neonates for bleeding [see warnings and precautions (5.3)] . labor or delivery all patients receiving anticoagulants, including pregnant women, are at risk for bleeding. savaysa use during labor or delivery in women who are receiving neuraxial anesthesia may result in epidural or spinal hematomas. consider use of a shorter acting anticoagulant as delivery approaches [see warnings and precautions (5.3)] . data animal data embryo-fetal development studies were conducted in pregnant rats and rabbits during the period of organogenesis. in rats, no malformation was seen when edoxaban was administered orally at doses up to 300 mg/kg/day, or 49 times the human dose of 60 mg/day normalized to body surface area. increased post-implantation loss occurred at 300 mg/kg/day, but this effect may be secondary to the maternal vaginal hemorrhage seen at this dose. in rabbits, no malformation was seen at doses up to 600 mg/kg/day (49 times the human exposure at a dose of 60 mg/day when based on auc). embryo-fetal toxicities occurred at maternally toxic doses, and included absent or small fetal gallbladder at 600 mg/kg/day, and increased post-implantation loss, increased spontaneous abortion, and decreased live fetuses and fetal weight at doses equal to or greater than 200 mg/kg/day, which is equal to or greater than 20 times the human exposure. in a rat pre- and post-natal developmental study, edoxaban was administered orally during the period of organogenesis and through lactation day 20 at doses up to 30 mg/kg/day, which is up to 3 times the human exposure when based on auc. vaginal bleeding in pregnant rats and delayed avoidance response (a learning test) in female offspring were seen at 30 mg/kg/day. risk summary there are no data on the presence of edoxaban in human milk, or its effects on the breastfeeding infant or on milk production. edoxaban was present in rat milk. because of the potential for serious adverse reactions in nursing infants, including hemorrhage, advise patients that breastfeeding is not recommended during treatment with savaysa. females of reproductive potential requiring anticoagulation should discuss pregnancy planning with their physician. the risk of clinically significant uterine bleeding, potentially requiring gynecological surgical interventions, identified with oral anticoagulants including savaysa should be assessed in females of reproductive potential and those with abnormal uterine bleeding. the safety and effectiveness of savaysa have not been established in pediatric patients with confirmed vte (pe and/or dvt). effectiveness was not demonstrated in an adequate and well-controlled study conducted in 145 savaysa-treated pediatric patients, from birth to less than 18 years of age with confirmed vte (pe and/or dvt), treated for 3 months up to a maximum of 12 months. of the total patients in the engage af-timi 48 study, 5182 (74%) were 65 years and older, while 2838 (41%) were 75 years and older. in hokusai vte, 1334 (32%) patients were 65 years and older, while 560 (14%) patients were 75 years and older. in the hokusai vte cancer study, 539 (52%) patients were 65 years and older and 176 (17%) were 75 years and older. in clinical trials the efficacy and safety of savaysa in elderly (65 years or older) and younger patients were similar [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14)] . renal clearance accounts for approximately 50% of the total clearance of edoxaban. consequently, edoxaban blood levels are increased in patients with poor renal function compared to those with higher renal function. reduce savaysa dose to 30 mg once daily in patients with crcl 15-50 ml/min. there are limited clinical data with savaysa in patients with crcl < 15 ml/min; savaysa is therefore not recommended in these patients. hemodialysis does not significantly contribute to savaysa clearance [see dosage and administration (2.1, 2.2) and clinical pharmacology (12.3)] . as renal function improves and edoxaban blood levels decrease, the risk for ischemic stroke increases in patients with nvaf [see indications and usage (1.1), dosage and administration (2.1), and clinical studies (14.1)] . the use of savaysa in patients with moderate or severe hepatic impairment (child-pugh b and c) is not recommended as these patients may have intrinsic coagulation abnormalities. no dose reduction is required in patients with mild hepatic impairment (child-pugh a) [see clinical pharmacology (12.3)] . based on the clinical experience from the hokusai vte study, reduce savaysa dose to 30 mg in patients with body weight less than or equal to 60 kg [see dosage and administration (2.2) and clinical studies (14.2)] .

Israel - inglês - Ministry of Health

medison pharma ltd - edoxaban as tosylate - film coated tablets - edoxaban as tosylate 15 mg - edoxaban - • prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (nvaf) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years,diabetes mellitus, prior stroke or transient ischaemic attack (tia).• treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and prevention of recurrent dvt and pe in adults

Israel - inglês - Ministry of Health

medison pharma ltd - edoxaban as tosylate - film coated tablets - edoxaban as tosylate 30 mg - edoxaban - • prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (nvaf) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years,diabetes mellitus, prior stroke or transient ischaemic attack (tia).• treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and prevention of recurrent dvt and pe in adults

Israel - inglês - Ministry of Health

medison pharma ltd - edoxaban as tosylate - film coated tablets - edoxaban as tosylate 60 mg - edoxaban - • prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (nvaf) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years,diabetes mellitus, prior stroke or transient ischaemic attack (tia).• treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and prevention of recurrent dvt and pe in adults

Bangladesh - inglês - DGDA (Directorate General of Drug Administration)

famous pharmaceuticals (unani) - sharbat gaozaban - liquid

União Europeia - inglês - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - edoxaban tosilate - stroke; venous thromboembolism - antithrombotic agents - prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (nvaf) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (tia).treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and prevention of recurrent dvt and pe in adults.

União Europeia - inglês - EMA (European Medicines Agency)

berlin-chemie ag - edoxaban tosilate - stroke; venous thromboembolism - antithrombotic agents - prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (nvaf) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (tia).treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and prevention of recurrent dvt and pe in adults.