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

arrotex pharmaceuticals pty ltd - quetiapine fumarate, quantity: 230.244 mg (equivalent: quetiapine, qty 200 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; sodium starch glycollate type a; calcium hydrogen phosphate dihydrate; purified talc; povidone; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - bipolar disorder,adults,? maintenance treatment of bipolar i 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 in combination with lithium or sodium valproate,children/adolescents aged 10 to 17 years,? monotherapy treatment of acute mania associated with bipolar i disorder,schizophrenia (adults and adolescents aged 13 to 17 years),? treatment of schizophrenia

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

arrotex pharmaceuticals pty ltd - quetiapine fumarate, quantity: 230.244 mg (equivalent: quetiapine, qty 200 mg) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate dihydrate; purified talc; microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate; titanium dioxide; lactose monohydrate; hypromellose; sodium starch glycollate type a; macrogol 400; povidone; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - bipolar disorder,adults,? maintenance treatment of bipolar i 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 in combination with lithium or sodium valproate,children/adolescents aged 10 to 17 years,? monotherapy treatment of acute mania associated with bipolar i disorder,schizophrenia (adults and adolescents aged 13 to 17 years),? treatment of schizophrenia

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

amneal pharma australia pty ltd - quetiapine fumarate, quantity: 230.244 mg (equivalent: quetiapine, qty 200 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; purified talc; titanium dioxide; colloidal anhydrous silica; lactose monohydrate; calcium hydrogen phosphate dihydrate; hypromellose; povidone; macrogol 400; sodium starch glycollate type a; magnesium stearate; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - bipolar disorder,adults,? maintenance treatment of bipolar i 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 in combination with lithium or sodium valproate,children/adolescents aged 10 to 17 years,? monotherapy treatment of acute mania associated with bipolar i disorder,schizophrenia (adults and adolescents aged 13 to 17 years),? treatment of schizophrenia

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

amneal pharma australia pty ltd - quetiapine fumarate, quantity: 230.244 mg (equivalent: quetiapine, qty 200 mg) - tablet, film coated - excipient ingredients: titanium dioxide; lactose monohydrate; calcium hydrogen phosphate dihydrate; sodium starch glycollate type a; macrogol 400; purified talc; povidone; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; hypromellose; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - bipolar disorder,adults,? maintenance treatment of bipolar i 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 in combination with lithium or sodium valproate,children/adolescents aged 10 to 17 years,? monotherapy treatment of acute mania associated with bipolar i disorder,schizophrenia (adults and adolescents aged 13 to 17 years),? treatment of schizophrenia

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

strides pharma science pty ltd - quetiapine fumarate, quantity: 230.244 mg (equivalent: quetiapine, qty 200 mg) - tablet, film coated - excipient ingredients: colloidal anhydrous silica; microcrystalline cellulose; magnesium stearate; sodium starch glycollate type a; calcium hydrogen phosphate dihydrate; purified talc; povidone; lactose monohydrate; hypromellose; titanium dioxide; macrogol 400; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - bipolar disorder,adults,? maintenance treatment of bipolar i 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 in combination with lithium or sodium valproate,children/adolescents aged 10 to 17 years,? monotherapy treatment of acute mania associated with bipolar i disorder,schizophrenia (adults and adolescents aged 13 to 17 years),? treatment of schizophrenia

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