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

arrotex pharmaceuticals pty ltd - quetiapine fumarate, quantity: 460.52 mg (equivalent: quetiapine, qty 400 mg) - tablet, modified release - excipient ingredients: microcrystalline cellulose; magnesium stearate; povidone; macrogol 400; lactose monohydrate; light magnesium oxide; titanium dioxide; carrageenan - bipolar disorder - maintenance treatment of bipolar 1 disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes. treatment of depressive episodes associated with bipolar disorder (see dosage and administration). treatment of acute mania associated with bipolar i disorder as monotherapy or incombination with lithium or sodium valproate. efficacy of quetiapine in the treatment of bipolar disorder indications was established in part, on the basis of extrapolation from the established effectiveness of quetiapine immediate release tablets. schizophrenia - treatment of schizophrenia, prevention of relapse and maintenance of clinical improvement during continuation therapy. major depressive disorder (mdd)- treatment of recurrent major depressive disorde in patients who are intolerant of, or who have an inadequate response to alternative therapies. generalised anxiety disorder (gad). treatment of generalised anxiety disorder.

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

arrotex pharmaceuticals pty ltd - quetiapine fumarate, quantity: 460.52 mg (equivalent: quetiapine, qty 400 mg) - tablet, modified release - excipient ingredients: carrageenan; light magnesium oxide; titanium dioxide; povidone; microcrystalline cellulose; macrogol 400; lactose monohydrate; magnesium stearate - bipolar disorder - maintenance treatment of bipolar 1 disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes. treatment of depressive episodes associated with bipolar disorder (see dosage and administration). treatment of acute mania associated with bipolar i disorder as monotherapy or incombination with lithium or sodium valproate. efficacy of quetiapine in the treatment of bipolar disorder indications was established in part, on the basis of extrapolation from the established effectiveness of quetiapine immediate release tablets. schizophrenia - treatment of schizophrenia, prevention of relapse and maintenance of clinical improvement during continuation therapy. major depressive disorder (mdd)- treatment of recurrent major depressive disorde in patients who are intolerant of, or who have an inadequate response to alternative therapies. generalised anxiety disorder (gad). treatment of generalised anxiety disorder.

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

arrotex pharmaceuticals pty ltd - quetiapine fumarate, quantity: 460.52 mg (equivalent: quetiapine, qty 400 mg) - tablet, modified release - excipient ingredients: titanium dioxide; carrageenan; lactose monohydrate; magnesium stearate; povidone; light magnesium oxide; macrogol 400; microcrystalline cellulose - bipolar disorder - maintenance treatment of bipolar 1 disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes. treatment of depressive episodes associated with bipolar disorder (see dosage and administration). treatment of acute mania associated with bipolar i disorder as monotherapy or incombination with lithium or sodium valproate. efficacy of quetiapine in the treatment of bipolar disorder indications was established in part, on the basis of extrapolation from the established effectiveness of quetiapine immediate release tablets. schizophrenia - treatment of schizophrenia, prevention of relapse and maintenance of clinical improvement during continuation therapy. major depressive disorder (mdd)- treatment of recurrent major depressive disorde in patients who are intolerant of, or who have an inadequate response to alternative therapies. generalised anxiety disorder (gad). treatment of generalised anxiety disorder.

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

gm pharma international pty ltd - quetiapine fumarate, quantity: 460.52 mg (equivalent: quetiapine, qty 400 mg) - tablet, modified release - excipient ingredients: magnesium stearate; povidone; lactose monohydrate; macrogol 400; light magnesium oxide; titanium dioxide; carrageenan; microcrystalline cellulose - bipolar disorder - maintenance treatment of bipolar 1 disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes. treatment of depressive episodes associated with bipolar disorder (see dosage and administration). treatment of acute mania associated with bipolar i disorder as monotherapy or incombination with lithium or sodium valproate. efficacy of quetiapine in the treatment of bipolar disorder indications was established in part, on the basis of extrapolation from the established effectiveness of quetiapine immediate release tablets. schizophrenia - treatment of schizophrenia, prevention of relapse and maintenance of clinical improvement during continuation therapy. major depressive disorder (mdd)- treatment of recurrent major depressive disorde in patients who are intolerant of, or who have an inadequate response to alternative therapies. generalised anxiety disorder (gad). treatment of generalised anxiety disorder.

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

major pharmaceuticals - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 25 mg - quetiapine fumarate tablets are indicated for the treatment of schizophrenia. the efficacy of quetiapine in schizophrenia was established in three 6 week trials in adults. the effectiveness of quetiapine for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials. [see clinical studies (14.1)].    pediatric use information in patients (13 to 17 years of age) with schizophrenia is approved for astrazeneca pharmaceuticals lp’s quetiapine fumarate drug product labeling. however, due to astrazeneca pharmaceuticals lp’s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients. quetiapine fumarate tablets are 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, [see clinical studies (14.2) ]. quetiapine fum

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

cardinal health - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 25 mg - quetiapine fumarate tablets are indicated for the treatment of schizophrenia. the efficacy of quetiapine in schizophrenia was established in three 6 week trials in adults. the effectiveness of quetiapine for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials. [see clinical studies (14.1)].    pediatric use information in patients (13 to 17 years of age) with schizophrenia is approved for astrazeneca pharmaceuticals lp’s quetiapine fumarate drug product labeling. however, due to astrazeneca pharmaceuticals lp’s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients. quetiapine fumarate tablets are 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, [see clinical studies (14.2) ]. quetiapine fum

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

physicians total care, inc. - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 50 mg - quetiapine fumarate tablets are indicated for the treatment of schizophrenia. the efficacyof quetiapine in schizophrenia was established in three 6 week trials in adults. the effectiveness of quetiapine for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials. [see clinical studies (14.1) ].    pediatric use information in patients (13 to 17 years of age) with schizophrenia is approved for astrazeneca pharmaceuticals lp’s quetiapine fumarate drug product labeling. however, due to astrazeneca pharmaceuticals lp’s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients. quetiapine fumarate tablets are 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, [see clinical studies (14.2) ]. quetiapine f

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

ncs healthcare of ky, inc dba vangard labs - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 100 mg - quetiapine fumarate tablets are indicated for the treatment of schizophrenia. the efficacy of quetiapine fumarate tablets in schizophrenia was established in three 6 week trials in adults and one 6 week trial in adolescents (13 to 17 years). the effectiveness of quetiapine fumarate tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see clinical studies (14.1)] . quetiapine fumarate tablets are 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 to 17 years) [see clinical studies (14.2)] . quetiapine fumarate tablets are indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. efficacy was established in two 8 week monoth

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

alembic pharmaceuticals limited - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 25 mg - quetiapine fumarate is indicated for the treatment of schizophrenia. the efficacy of quetiapine fumarate  in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). the effectiveness of quetiapine fumarate  for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see clinical studies (14.1) ]. quetiapine fumarate  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 to 17 years) [see clinical studies (14.2)]. quetiapine fumarate 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 bipo

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

dr.reddy's laboratories limited - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 50 mg - quetiapine fumarate tablets are indicated for the treatment of schizophrenia. the efficacy of quetiapine fumarate tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). the effectiveness of quetiapine fumarate tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see clinical studies (14.1) ]. quetiapine fumarate tablets are 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 to 17 years) [ see clinical studies (14.2)]. quetiapine fumarate tablets are indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. efficacy was established in two 8-week monoth