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

accord healthcare pty ltd - capecitabine, quantity: 150 mg - tablet, film coated - excipient ingredients: iron oxide red; iron oxide yellow; lactose; purified water; titanium dioxide; croscarmellose sodium; hypromellose; microcrystalline cellulose; magnesium stearate; purified talc - colon cancer:,capecitabine is indicated for the adjuvant treatment of patients with duke?s stage c and highrisk stage b, colon cancer, either as monotherapy or in combination with oxaliplatin.,colorectal cancer:,capecitabine is indicated for the treatment of patients with advanced or metastatic colorectal cancer.,oesophagogastric cancer:,capecitabine is indicated for the first-line treatment of patients with advanced oesophagogastric cancer in combination with a platinum-based regimen.,breast cancer:,capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen unless therapy with these and other standard agents are clinically contraindicated.,capecitabine in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy.

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

accord healthcare pty ltd - capecitabine, quantity: 500 mg - tablet, film coated - excipient ingredients: lactose; purified talc; titanium dioxide; magnesium stearate; microcrystalline cellulose; hypromellose; croscarmellose sodium; iron oxide red; purified water; iron oxide yellow - colon cancer:,capecitabine is indicated for the adjuvant treatment of patients with duke?s stage c and highrisk stage b, colon cancer, either as monotherapy or in combination with oxaliplatin.,colorectal cancer:,capecitabine is indicated for the treatment of patients with advanced or metastatic colorectal cancer.,oesophagogastric cancer:,capecitabine is indicated for the first-line treatment of patients with advanced oesophagogastric cancer in combination with a platinum-based regimen.,breast cancer:,capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen unless therapy with these and other standard agents are clinically contraindicated.,capecitabine in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy.

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)

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

Malta - English - Medicines Authority

focused pharma ltd 37, geronimo abos street, iklin ikl 1022, malta - ivabradine - film-coated tablet - ivabradine 7.5 mg - cardiac therapy

Malta - English - Medicines Authority

focused pharma ltd 37, geronimo abos street, iklin ikl 1022, malta - ivabradine - film-coated tablet - ivabradine 5 mg - cardiac therapy

New Zealand - English - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - temozolomide 100mg;   - capsule - 100 mg - active: temozolomide 100mg   excipient: colloidal silicon dioxide gelatin lactose sodium starch glycolate stearic acid tartaric acid tekprint black sw-9008 - temaccord capsules are indicated for the treatment of patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as adjuvant treatment.

New Zealand - English - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - temozolomide 140mg;   - capsule - 140 mg - active: temozolomide 140mg   excipient: colloidal silicon dioxide gelatin lactose sodium starch glycolate stearic acid tartaric acid tekprint black sw-9008 - temaccord capsules are indicated for the treatment of patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as adjuvant treatment.