Philippines - English - FDA (Food And Drug Administration)

astrazeneca pharmaceuticals (phils.), inc. - seroquel xr - extended-release tablet - 150 mg

Philippines - English - FDA (Food And Drug Administration)

astrazeneca pharmaceuticals (phils.), inc. - seroquel xr - extended-release tablet - 200 mg

Philippines - English - FDA (Food And Drug Administration)

astrazeneca pharmaceuticals (phils.), inc. - seroquel xr - extended-release tablet - 300 mg

Philippines - English - FDA (Food And Drug Administration)

astrazeneca uk limited; importer: astrazeneca pharmaceuticals (phils.), inc. - saxagliptin (as hydrochloride) , metformin hydrochloride (in extended release form) - film-coated tablet - 2.5mg/ 1g

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

astrazeneca pharmaceuticals lp - ticagrelor (unii: glh0314rvc) (ticagrelor - unii:glh0314rvc) - ticagrelor 90 mg - brilinta is indicated to reduce the risk of cardiovascular (cv) death, myocardial infarction (mi), and stroke in patients with acute coronary syndrome (acs) or a history of mi. for at least the first 12 months following acs, it is superior to clopidogrel. brilinta also reduces the risk of stent thrombosis in patients who have been stented for treatment of acs [see clinical studies (14.1)] . brilinta is indicated to reduce the risk of a first mi or stroke in patients with coronary artery disease (cad) at high risk for such events [see clinical studies (14.2)] . while use is not limited to this setting, the efficacy of brilinta was established in a population with type 2 diabetes mellitus (t2dm). brilinta is indicated to reduce the risk of stroke in patients with acute ischemic stroke (nih stroke scale score ≤5) or high-risk transient ischemic attack (tia) [see clinical studies (14.3)] . brilinta is contraindicated in patients with a history of intracranial hemorrhage (ich) because of a high risk of recurrent i

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

astrazeneca pharmaceuticals lp - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 200 mg - seroquel xr is indicated for the treatment of schizophrenia. the efficacy of seroquel xr in schizophrenia was established in one 6-week and one maintenance trial in adults with schizophrenia. efficacy was supported by three 6-week trials in adults with schizophrenia and one 6-week trial in adolescents with schizophrenia (13-17 years) treated with seroquel [see clinical studies (14.1)]. seroquel xr is indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. the efficacy of seroquel xr in manic or mixed episodes of bipolar i disorder was established in one 3-week trial in adults with manic or mixed episodes associated with bipolar i disorder. efficacy was supported by two 12-week monotherapy trials and one 3-week adjunctive trial in adults with manic episodes associated with bipolar i disorder as well as one 3-week monotherapy trial in children and adolescents (10 - 17 years) with manic episodes associated wi

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

astrazeneca pharmaceuticals lp - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 25 mg - seroquel is indicated for the treatment of schizophrenia. the efficacy of seroquel in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13-17 years). the effectiveness of seroquel for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see clinical studies (14.1)]. seroquel is indicated for the acute treatment of manic episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10-17 years) [see clinical studies (14.2)]. seroquel is indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. efficacy was established in two 8-week monotherapy trials in adult patients with bipolar i and bipolar ii disorder [see clinical studies (14.2)]. seroq

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

astrazeneca pharmaceuticals lp - olaparib (unii: woh1jd9ar8) (olaparib - unii:woh1jd9ar8) - olaparib 100 mg - lynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic brca -mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. select patients for therapy based on an fda-approved companion diagnostic for lynparza [see dosage and administration (2.1) ] . lynparza is indicated in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (hrd)-positive status defined by either: select patients for therapy based on an fda-approved companion diagnostic for lynparza [see dosage and administration (2.1)]. lynparza is indicated for the maintenance treatment of adult patients with deleterious or su

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

astrazeneca pharmaceuticals lp - saxagliptin hydrochloride (unii: z8j84yix6l) (saxagliptin anhydrous - unii:8i7io46ivq), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - saxagliptin anhydrous 2.5 mg - kombiglyze xr is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate [see clinical studies (14) ]. kombiglyze xr is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. kombiglyze xr is contraindicated in patients with: limited available data with kombiglyze xr or saxagliptin in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage. published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see data ]. no adverse developmental effects independent of maternal toxicity were observed when saxagliptin and metformin were administered separately or in combination to pregnant rats and rabbits during the period of organogenesis [see data ]. the estimated background risk of major birth defects is 6 to 10% in women w

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

astrazeneca pharmaceuticals lp - glycopyrrolate (unii: v92so9wp2i) (glycopyrronium - unii:a14fb57v1d), formoterol fumarate (unii: w34shf8j2k) (formoterol - unii:5zz84gcw8b) - glycopyrrolate 9 ug - bevespi aerosphere is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (copd). limitations of use: bevespi aerosphere is not indicated for the relief of acute bronchospasm or for the treatment of asthma [see warnings and precautions (5.1, 5.2)] . bevespi aerosphere is contraindicated in: risk summary   there are no adequate and well-controlled trials of bevespi aerosphere or its individual components, glycopyrrolate and formoterol fumarate, in pregnant women to inform a drug-associated risk. in animal reproduction studies, glycopyrrolate alone, administered by the subcutaneous route in rats and rabbits, did not cause structural abnormalities or affect fetal survival at exposures approximately 2700 and 5400 times from the maximum recommended human daily inhalation dose (mrhdid), respectively. glycopyrrolate had no effects on the physical, functional, and behavioral development of rat pups with exposures up to 2700 times the mrhdid. formoterol fumarate alone, admin