Unia Europejska - angielski - EMA (European Medicines Agency)

rad neurim pharmaceuticals eec sarl - melatonin - sleep initiation and maintenance disorders - psycholeptics - melatonin neurim is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.

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

maxx pharma pty ltd - insulin glargine, quantity: 100 u/ml - injection, solution - excipient ingredients: sodium hydroxide; glycerol; water for injections; hydrochloric acid; metacresol; zinc chloride - insulin glargine is an insulin analogue indicated for once-daily subcutaneous administration in the treatment of type 1 diabetes mellitus in adults and children and type 2 diabetes mellitus in adults who require insulin for the control of hyperglycaemia.

Izrael - angielski - Ministry of Health

abbvie biopharmaceuticals ltd, israel - carbidopa as monohydrate; levodopa - gel - levodopa 20 mg/ml; carbidopa as monohydrate 5 mg/ml - levodopa - levodopa - treatment of advanced levodopa-responsive parkinson's disease with severe motor fluctuations and hyper-/dyskinesia when available combinations of parkinson medicinal products have not given satisfactory results.

Izrael - angielski - Ministry of Health

neurim pharmaceuticals (1991) ltd, israel - melatonin - tablets prolonged release - melatonin 2 mg - melatonin - melatonin - short-term treatment for primary insomnia characterized by poor quality of sleep in patients who are aged 55 or over.

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

homart pharmaceuticals pty ltd - humulus lupulus, quantity: 40 mg (equivalent: humulus lupulus, qty 300 mg); valeriana officinalis, quantity: 500 mg (equivalent: valeriana officinalis, qty 2 g) - tablet, film coated - excipient ingredients: hypromellose; povidone; croscarmellose sodium; colloidal anhydrous silica; crospovidone; iron oxide red; magnesium stearate; macrogol 8000; carnauba wax; calcium hydrogen phosphate dihydrate; microcrystalline cellulose - maintain/support general health and wellbeing ; traditionally used in western herbal medicine to decrease/reduce/relieve colic (wind/gas pain) ; traditionally used in western herbal medicine to decrease/reduce/relieve flatulence/carminative ; traditionally used in western herbal medicine to decrease/reduce/relieve symptoms of indigestion/dyspepsia ; traditionally used in western herbal medicine to decrease/reduce/relieve restlessness/excess nervous energy ; traditionally used in western herbal medicine to decrease/reduce/relieve nervous tension/unrest ; traditionally used in western herbal medicine to decrease/reduce/relieve symptoms of mild anxiety ; traditionally used in western herbal medicine to decrease/reduce/relieve sleeplessness ; traditionally used in western herbal medicine to decrease/reduce/relieve disturbed/restless sleep

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - clopidogrel bisulfate (unii: 08i79htp27) (clopidogrel - unii:a74586sno7) - clopidogrel 75 mg - 1.1 acute coronary syndrome (acs) - clopidogrel is indicated to reduce the rate of myocardial infarction and stroke (mi) in patients with non-st-segment elevation acs [unstable angina (ua)/non-st-elevation myocardial infarction (nstemi)], including patients who are to be managed medically and those who are to be managed with coronary revascularization. clopidogrel should be administered in conjunction with aspirin. - clopidogrel is indicated to reduce the rate of myocardial infarction and stroke in patients with acute st-elevation myocardial infarction (stemi) who are to be managed medically. clopdiogrel should be administered in conjunction with aspirin. 1.2 recent mi, recent stroke, or established peripheral arterial disease in patients with established peripheral arterial disease or with a history of recent myocardial infarction (mi) or recent stroke clopdigorel is indicated to reduce the rate of mi and stroke. 4.1 active bleeding clopidogrel is contraindicated in patients with active pathological bleeding

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

camber pharmaceuticals, inc. - clopidogrel bisulfate (unii: 08i79htp27) (clopidogrel - unii:a74586sno7) - clopidogrel 75 mg - •clopidogrel is indicated to reduce the rate of myocardial infarction (mi) and stroke in patients with non-st-segment elevation acs [unstable angina (ua)/non-st-elevation myocardial infarction (nstemi)], including patients who are to be managed medically and those who are to be managed with coronary revascularization. clopidogrel should be administered in conjunction with aspirin. •clopidogrel is indicated to reduce the rate of myocardial infarction and stroke in patients with acute st-elevation myocardial infarction (stemi) who are to be managed medically. clopdiogrel should be administered in conjunction with aspirin. in patients with established peripheral arterial disease or with a history of recent myocardial infarction (mi) or recent stroke clopdigorel is indicated to reduce the rate of mi and stroke. clopidogrel is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. clopidogrel is contraindicated in patients with hypersensitivity (e.g.,

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - clopidogrel bisulfate (unii: 08i79htp27) (clopidogrel - unii:a74586sno7) - clopidogrel 75 mg - in patients with established peripheral arterial disease or with a history of recent myocardial infarction (mi) or recent stroke clopidogrel tablets are indicated to reduce the rate of mi and stroke. clopidogrel tablets are contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. clopidogrel tablets are contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to clopidogrel or any component of the product [see adverse reactions (6.2)] . available data from cases reported in published literature and postmarketing surveillance with clopidogrel use in pregnant women have not identified any drug-associated risks for major birth defects or miscarriage [see data] . there are risks to the pregnant woman and fetus associated with myocardial infarction and stroke [see clinical considerations] . no evidence of fetotoxicity was observed when clopidogrel was administered to pregnant rats and rabbits during organogenesis at doses corresponding to 65 and 78

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

amneal pharmaceuticals llc - clopidogrel bisulfate (unii: 08i79htp27) (clopidogrel - unii:a74586sno7) - clopidogrel 75 mg - - clopidogrel tablets are indicated to reduce the rate of myocardial infarction (mi) and stroke in patients with non-st-segment elevation acs [unstable angina (ua)/non-st-elevation myocardial infarction (nstemi)], including patients who are to be managed medically and those who are to be managed with coronary revascularization. clopidogrel tablets should be administered in conjunction with aspirin. - clopidogrel tablets are indicated to reduce the rate of myocardial infarction and stroke in patients with acute st-elevation myocardial infarction (stemi) who are to be managed medically. clopidogrel tablets should be administered in conjunction with aspirin. in patients with established peripheral arterial disease or with a history of recent myocardial infarction (mi) or recent stroke clopidogrel tablets are indicated to reduce the rate of mi and stroke. clopidogrel is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. clopidogrel tablets are contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to clopidogrel or any component of the product [see adverse reactions (6.2)] . risk summary available data from cases reported in published literature and post-marketing surveillance with clopidogrel use in pregnant women have not identified any drug-associated risks for major birth defects or miscarriage [see data]. there are risks to the pregnant woman and fetus associated with myocardial infarction and stroke [see clinical considerations] . no evidence of fetotoxicity was observed when clopidogrel was administered to pregnant rats and rabbits during organogenesis at doses corresponding to 65 and 78 times the recommended daily human dose [see data] . the estimated background risk of major birth defects and miscarriage for the indicated populations 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% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk myocardial infarction and stroke are medical emergencies. therapy for the pregnant woman should not be withheld because of potential concerns regarding the effects of clopidogrel on the fetus. labor or delivery clopidogrel use during labor or delivery will increase the risk of maternal bleeding and hemorrhage. avoid neuraxial blockade during clopidogrel use because of the risk of spinal hematoma. when possible, discontinue clopidogrel 5 to 7 days prior to labor, delivery, or neuraxial blockade. data human data the available data from published case reports over two decades of post-marketing use have not identified an association with clopidogrel use in pregnancy and major birth defects, miscarriage, or adverse fetal outcomes. animal data embryo-fetal developmental toxicology studies were performed in pregnant rats and rabbits with doses up to 500 and 300 mg/kg/day, respectively, administered during organogenesis. these doses, corresponding to 65 and 78 times the recommended daily human dose, respectively, on a mg/m2 basis, revealed no evidence of impaired fertility or fetotoxicity due to clopidogrel. risk summary there are no data on the presence of clopidogrel in human milk or the effects on milk production. no adverse effects on breastfed infants have been observed with maternal clopidogrel use during lactation in a small number of post-marketing cases. studies in rats have shown that clopidogrel and/or its metabolites are present in the milk. when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for clopidogrel and any potential adverse effects on the breastfed infant from clopidogrel or from underlying maternal condition. safety and effectiveness in pediatric populations have not been established. a randomized, placebo-controlled trial (clarinet) did not demonstrate a clinical benefit of clopidogrel in neonates and infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary arterial shunt. possible factors contributing to this outcome were the dose of clopidogrel, the concomitant administration of aspirin and the late initiation of therapy following shunt palliation. it cannot be ruled out that a trial with a different design would demonstrate a clinical benefit in this patient population. of the total number of subjects in the caprie and cure controlled clinical studies, approximately 50% of patients treated with clopidogrel were 65 years of age and older, and 15% were 75 years and older. in commit, approximately 58% of the patients treated with clopidogrel were 60 years and older, 26% of whom were 70 years and older. the observed risk of bleeding events with clopidogrel plus aspirin versus placebo plus aspirin by age category is provided in table 1 and table 2 for the cure and commit trials, respectively [see adverse reactions (6.1)] . no dosage adjustment is necessary in elderly patients. experience is limited in patients with severe and moderate renal impairment [see clinical pharmacology (12.2)] . no dosage adjustment is necessary in patients with hepatic impairment [see clinical pharmacology (12.2)] .

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - armodafinil (unii: v63xwa605i) (armodafinil - unii:v63xwa605i) - armodafinil 50 mg - armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (osa), narcolepsy, or shift work disorder (swd). limitations of use in osa, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. if continuous positive airway pressure (cpap) is the treatment of choice for a patient, a maximal effort to treat with cpap for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness. armodafinil tablets are contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients [see warnings and precautions (5.1, 5.2, 5.3)] . risk summary limited available data on armodafinil use in pregnant women are insufficient to inform a drug associated risk of adverse pregnancy outcomes. intrauterine growth restriction and spontaneous abortion have been reported in association with armodafinil and mod