Ireland - English - HPRA (Health Products Regulatory Authority)

rowex ltd - quetiapine - prolonged-release tablet - 300 milligram(s) - diazepines, oxazepines, thiazepines and oxepines; quetiapine - antipsychotics; diazepines, oxazepines, thiazepines and oxepines - quetex xr is indicated for: treatment of schizophrenia. treatment of bipolar disorder: - for the treatment of moderate to severe manic episodes in bipolar disorder - for the treatment of major depressive episodes associated with bipolar disorder - for the prevention of recurrence of manic or depressed episodes in patients with bipolar disorder who previously responded to quetiapine treatment. add-on treatment of major depressive episodes in patients with major depressive disorder (mdd) who have had sub-optimal response to antidepressant monotherapy (see section 5.1). prior to initiating treatment, clinicians should consider the safety profile of quetiapine

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

accord healthcare pty ltd - quetiapine fumarate, quantity: 28.78 mg (equivalent: quetiapine, qty 25 mg) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate dihydrate; sodium starch glycollate type a; magnesium stearate; lactose monohydrate; microcrystalline cellulose; povidone; titanium dioxide; hypromellose; iron oxide yellow; iron oxide red; macrogol 400 - 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)

accord healthcare pty ltd - quetiapine fumarate, quantity: 345.36 mg (equivalent: quetiapine, qty 300 mg) - tablet, film coated - excipient ingredients: magnesium stearate; calcium hydrogen phosphate dihydrate; lactose monohydrate; microcrystalline cellulose; sodium starch glycollate type a; hypromellose; titanium dioxide; macrogol 400; povidone - 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)

accord healthcare pty ltd - quetiapine fumarate, quantity: 230.24 mg (equivalent: quetiapine, qty 200 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; sodium starch glycollate type a; microcrystalline cellulose; povidone; titanium dioxide; hypromellose; macrogol 400; magnesium stearate; calcium hydrogen phosphate dihydrate - 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)

accord healthcare pty ltd - quetiapine fumarate, quantity: 115.12 mg (equivalent: quetiapine, qty 100 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; calcium hydrogen phosphate dihydrate; povidone; lactose monohydrate; sodium starch glycollate type a; magnesium stearate; titanium dioxide; hypromellose; iron oxide yellow; macrogol 400 - 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: 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)

arrotex pharmaceuticals pty ltd - quetiapine fumarate, quantity: 172.695 mg (equivalent: quetiapine, qty 150 mg) - tablet, modified release - excipient ingredients: magnesium stearate; titanium dioxide; lactose monohydrate; povidone; light magnesium oxide; microcrystalline cellulose; carrageenan; macrogol 400 - 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: 57.565 mg (equivalent: quetiapine, qty 50 mg) - tablet, modified release - excipient ingredients: povidone; titanium dioxide; carrageenan; light magnesium oxide; lactose monohydrate; magnesium stearate; iron oxide red; macrogol 400; microcrystalline cellulose; iron oxide yellow - 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: 345.39 mg (equivalent: quetiapine, qty 300 mg) - tablet, modified release - excipient ingredients: carrageenan; titanium dioxide; macrogol 400; microcrystalline cellulose; povidone; lactose monohydrate; magnesium stearate; iron oxide yellow; light magnesium oxide - 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: 230.26 mg (equivalent: quetiapine, qty 200 mg) - tablet, modified release - excipient ingredients: carrageenan; macrogol 400; magnesium stearate; povidone; lactose monohydrate; light magnesium oxide; microcrystalline cellulose; iron oxide yellow; titanium dioxide - 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.