אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - ethinylestradiol, quantity: 20 microgram; levonorgestrel, quantity: 100 microgram - tablet, film coated - excipient ingredients: lactose monohydrate; macrogol 1500; magnesium stearate; microcrystalline cellulose; glycol montanate; polacrilin potassium; titanium dioxide; hypromellose; hyprolose; macrogol 400 - 1. the prevention of pregnancy. 2. the treatment of moderate acne vulgaris not controlled with topical preparations in post-menarchal, pre-menopausal women who accept contraception.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

generic health pty ltd - alendronate sodium, quantity: 10.884 mg (equivalent: alendronic acid, qty 10 mg) - tablet, uncoated - excipient ingredients: mannitol; croscarmellose sodium; purified talc; colloidal anhydrous silica; magnesium stearate - *for the treatment of osteoporosis. osteoporosis must be confirmed by: the finding of low bone mass of at least 2 standard deviations below the gender specific mean for young adults or by the presence of osteoporotic fracture. * treatment and prevention of glucocorticoid-induced osteoporosis in post menopausal women not receiving oestrogen and who are on long term corticosteroid therapy.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - lapatinib ditosilate monohydrate, quantity: 405 mg (equivalent: lapatinib, qty 250 mg) - tablet, film coated - excipient ingredients: sodium starch glycollate type a; magnesium stearate; microcrystalline cellulose; povidone; titanium dioxide; hypromellose; polysorbate 80; iron oxide yellow; iron oxide red; macrogol 400 - human epidermal growth factor receptor 2 positive (her2+) over expressing advanced or metastatic breast cancer,tykerb is indicated in combination with:,? an aromatase inhibitor for the treatment of post-menopausal women with hormone receptor-positive metastatic breast cancer whose tumours overexpress her2 (erbb2) (epidermal growth factor receptor 2) and for whom hormonal therapy is indicated.,? capecitabine for the treatment of patients with advanced/metastatic breast cancer whose tumours overexpress her2 (erbb2) and whose tumours have progressed after treatment with an anthracycline and a taxane, and who have progressed on prior trastuzumab therapy in the metastatic setting.,? paclitaxel for the first-line treatment of patients with metastatic breast cancer whose tumours overexpress her2 (erbb2) and for whom trastuzumab is not appropriate (see section 5.1 pharmacodynamic properties - clinical trials).

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

clinect pty ltd - clonidine hydrochloride, quantity: 100 microgram - tablet, uncoated - excipient ingredients: colloidal anhydrous silica; lactose monohydrate; soluble maize starch; maize starch; stearic acid; calcium hydrogen phosphate; povidone - indications as at 8 nov 1984: all grades of essential hypertension. renal hypertension. the prophylactic management of migraine or recurrent vascular headaches which occur in adult patients with a frequency of more than once a month and are not adequately relieved by appropriate therapy for the acute attack. alleviation of symptoms due to localised vasodilatation in menopausal flushing.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - clonidine hydrochloride, quantity: 100 microgram - tablet - excipient ingredients: maize starch; hyprolose; calcium hydrogen phosphate dihydrate; lactose monohydrate; microcrystalline cellulose; allura red ac; magnesium stearate; colloidal anhydrous silica - oral: all grades of essential hypertension. renal hypertension.,the prophylactic management of migraine or recurrent vascular headaches which occur in adult patients with a frequency of more than once a month and are not adequately relieved by appropriate therapy for the acute attack. alleviation of symptoms due to localised vasodilatation in menopausal flushing.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

orion pharma (aus) pty limited - toremifene citrate, quantity: 88.5 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; colloidal anhydrous silica; sodium starch glycollate; microcrystalline cellulose; magnesium stearate; povidone; maize starch - for the first line treatment of hormone-dependent metastatic breast cancer in postmenopausal women. it is not recommended for patients with oestrogen receptor negative tumours.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

generic health pty ltd - risperidone, quantity: 4 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; colloidal anhydrous silica; pregelatinised maize starch; lactose monohydrate; sodium lauryl sulfate; purified talc; magnesium stearate; titanium dioxide; hypromellose; propylene glycol; iron oxide red - ? risperidone tablets are indicated for the treatment of schizophrenia and related psychoses. ? risperidone tablets are indicated for the short-term treatment of acute mania associated with bipolar 1 disorder (see section 4.2 dose and method of administration ? bipolar mania)). ? risperidone tablets are also indicated for the treatment (up to 12 weeks) of psychotic symptoms, or persistent agitation or aggression unresponsive to non-pharmacological approaches in patients with moderate to severe dementia of the alzheimer type. (see section 4.2 dose and method of administration: behavioural disturbances in dementia) ? risperidone tablets are indicated in the treatment of conduct and other disruptive disorders in children (over 5 years), adolescents and adults with sub average intellectual functioning or mental retardation in whom destructive behaviours (eg. aggression, impulsivity and self-injurious behaviours) are prominent. (see section 5.1 pharmacodynamic properties ? clinical trials for maintenance data). ? risperidone tablets are indicated for the treatment of behavioural disorders associated with autism in children and adolescents (see section 5.1 pharmacodynamic properties ? clinical trials)

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

generic health pty ltd - risperidone, quantity: 3 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; colloidal anhydrous silica; pregelatinised maize starch; lactose monohydrate; sodium lauryl sulfate; purified talc; magnesium stearate; titanium dioxide; hypromellose; propylene glycol; iron oxide yellow - ? risperidone tablets are indicated for the treatment of schizophrenia and related psychoses. ? risperidone tablets are indicated for the short-term treatment of acute mania associated with bipolar 1 disorder (see section 4.2 dose and method of administration ? bipolar mania)). ? risperidone tablets are also indicated for the treatment (up to 12 weeks) of psychotic symptoms, or persistent agitation or aggression unresponsive to non-pharmacological approaches in patients with moderate to severe dementia of the alzheimer type. (see section 4.2 dose and method of administration: behavioural disturbances in dementia) ? risperidone tablets are indicated in the treatment of conduct and other disruptive disorders in children (over 5 years), adolescents and adults with sub average intellectual functioning or mental retardation in whom destructive behaviours (eg. aggression, impulsivity and self-injurious behaviours) are prominent. (see section 5.1 pharmacodynamic properties ? clinical trials for maintenance data). ? risperidone tablets are indicated for the treatment of behavioural disorders associated with autism in children and adolescents (see section 5.1 pharmacodynamic properties ? clinical trials)

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

generic health pty ltd - risperidone, quantity: 2 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; colloidal anhydrous silica; pregelatinised maize starch; lactose monohydrate; sodium lauryl sulfate; purified talc; magnesium stearate; titanium dioxide; hypromellose; propylene glycol; sunset yellow fcf aluminium lake - ? risperidone tablets are indicated for the treatment of schizophrenia and related psychoses. ? risperidone tablets are indicated for the short-term treatment of acute mania associated with bipolar 1 disorder (see section 4.2 dose and method of administration ? bipolar mania)). ? risperidone tablets are also indicated for the treatment (up to 12 weeks) of psychotic symptoms, or persistent agitation or aggression unresponsive to non-pharmacological approaches in patients with moderate to severe dementia of the alzheimer type. (see section 4.2 dose and method of administration: behavioural disturbances in dementia) ? risperidone tablets are indicated in the treatment of conduct and other disruptive disorders in children (over 5 years), adolescents and adults with sub average intellectual functioning or mental retardation in whom destructive behaviours (eg. aggression, impulsivity and self-injurious behaviours) are prominent. (see section 5.1 pharmacodynamic properties ? clinical trials for maintenance data). ? risperidone tablets are indicated for the treatment of behavioural disorders associated with autism in children and adolescents (see section 5.1 pharmacodynamic properties ? clinical trials)

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

generic health pty ltd - risperidone, quantity: 1 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; colloidal anhydrous silica; pregelatinised maize starch; lactose monohydrate; sodium lauryl sulfate; purified talc; magnesium stearate; titanium dioxide; hypromellose; propylene glycol - ? risperidone tablets are indicated for the treatment of schizophrenia and related psychoses. ? risperidone tablets are indicated for the short-term treatment of acute mania associated with bipolar 1 disorder (see section 4.2 dose and method of administration ? bipolar mania)). ? risperidone tablets are also indicated for the treatment (up to 12 weeks) of psychotic symptoms, or persistent agitation or aggression unresponsive to non-pharmacological approaches in patients with moderate to severe dementia of the alzheimer type. (see section 4.2 dose and method of administration: behavioural disturbances in dementia) ? risperidone tablets are indicated in the treatment of conduct and other disruptive disorders in children (over 5 years), adolescents and adults with sub average intellectual functioning or mental retardation in whom destructive behaviours (eg. aggression, impulsivity and self-injurious behaviours) are prominent. (see section 5.1 pharmacodynamic properties ? clinical trials for maintenance data). ? risperidone tablets are indicated for the treatment of behavioural disorders associated with autism in children and adolescents (see section 5.1 pharmacodynamic properties ? clinical trials)