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

novartis pharmaceuticals australia pty ltd - trametinib dimethyl sulfoxide, quantity: 2.254 mg (equivalent: trametinib, qty 2 mg) - tablet, film coated - excipient ingredients: mannitol; colloidal anhydrous silica; microcrystalline cellulose; magnesium stearate; croscarmellose sodium; sodium lauryl sulfate; hypromellose; titanium dioxide; polysorbate 80; iron oxide red; macrogol 400 - unresectable or metastatic melanoma,mekinist in combination with dabrafenib is indicated for the treatment of patients with braf v600 mutation positive unresectable stage iii or metastatic (stage iv) melanoma.,mekinist as a monotherapy is indicated for the treatment of patients with braf v600 mutation positive unresectable stage iii or metastatic (stage iv) melanoma and in whom either there is intolerance to braf inhibitors or braf inhibitors cannot be used.,mekinist as monotherapy has not demonstrated clinical activity in patients who have progressed on braf inhibitor therapy (see section 5.1 clinical trials).,adjuvant treatment of melanoma,mekinist in combination with dabrafenib is indicated for the adjuvant treatment of patients with melanoma with a braf v600 mutation and involvement of the lymph node(s), following complete resection.,anaplastic thyroid cancer (atc),mekinist in combination with dabrafenib is indicated for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (atc) with a braf v600 mutation and with no satisfactory locoregional treatment options.,non-small cell lung cancer (nsclc),mekinist in combination with dabrafenib is indicated for the treatment of patients with advanced non-small cell lung cancer (nsclc) with a braf v600 mutation.,low-grade glioma,mekinist in combination with dabrafenib is indicated for the treatment of paediatric patients 1 year of age and older with low-grade glioma (lgg) with a braf v600e mutation who require systemic therapy (see section 5.1 clinical studies).,high-grade glioma,mekinist in combination with dabrafenib is indicated for the treatment of paediatric patients 1 year of age and older with high-grade glioma (hgg) with a braf v600e mutation who have progressed following prior treatment and have no satisfactory alternative treatment options (see section 5.1 clinical studies). .

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

novartis pharmaceuticals australia pty ltd - trametinib dimethyl sulfoxide, quantity: 0.5635 mg (equivalent: trametinib, qty 0.5 mg) - tablet, film coated - excipient ingredients: sodium lauryl sulfate; hypromellose; mannitol; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; croscarmellose sodium; titanium dioxide; iron oxide yellow; macrogol 400 - unresectable or metastatic melanoma,mekinist in combination with dabrafenib is indicated for the treatment of patients with braf v600 mutation positive unresectable stage iii or metastatic (stage iv) melanoma.,mekinist as a monotherapy is indicated for the treatment of patients with braf v600 mutation positive unresectable stage iii or metastatic (stage iv) melanoma and in whom either there is intolerance to braf inhibitors or braf inhibitors cannot be used.,mekinist as monotherapy has not demonstrated clinical activity in patients who have progressed on braf inhibitor therapy (see section 5.1 clinical trials).,adjuvant treatment of melanoma,mekinist in combination with dabrafenib is indicated for the adjuvant treatment of patients with melanoma with a braf v600 mutation and involvement of the lymph node(s), following complete resection.,anaplastic thyroid cancer (atc),mekinist in combination with dabrafenib is indicated for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (atc) with a braf v600 mutation and with no satisfactory locoregional treatment options.,non-small cell lung cancer (nsclc),mekinist in combination with dabrafenib is indicated for the treatment of patients with advanced non-small cell lung cancer (nsclc) with a braf v600 mutation.,low-grade glioma,mekinist in combination with dabrafenib is indicated for the treatment of paediatric patients 1 year of age and older with low-grade glioma (lgg) with a braf v600e mutation who require systemic therapy (see section 5.1 clinical studies).,high-grade glioma,mekinist in combination with dabrafenib is indicated for the treatment of paediatric patients 1 year of age and older with high-grade glioma (hgg) with a braf v600e mutation who have progressed following prior treatment and have no satisfactory alternative treatment options (see section 5.1 clinical studies).

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

inova pharmaceuticals (australia) pty ltd - prednisone, quantity: 5 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; propyl hydroxybenzoate; wheat starch; maize starch; magnesium stearate; gelatin - indications as at 26 march 1997 : wherever corticosteroid therapy is indicated.

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

arrow pharma pty ltd - captopril, quantity: 50 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; stearic acid; maize starch; lactose monohydrate - 1.hypertension: capoten (captopril) is indicated for the treatment of hypertension. in using capoten, consideration should be given to the risk of neutropenia/agranulocytosis (see precautions). capoten is effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. the blood pressure lowering effects of captopril and thiazides are approximately additive. 2. myocardial infarction: capoten is indicated to improve survival following myocardial infarction in clinically stable patients with left ventricular dysfunction manifested as an ejection fraction less than or equal to 40%, and to reduce the incidence of overt heart failure and subsequent hospitalisations for congestive heart failure in these patients. the efficacy data for the use of captopril following myocardial infarction are strongest for initiation of therapy beyond 3 days post-infarct. 3. heart failure: capoten (captopril) is indicated for the treatment of heart failure. in symptomatic patients it is recom

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

arrow pharma pty ltd - captopril, quantity: 25 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; stearic acid; microcrystalline cellulose; maize starch - 1.hypertension: capoten (captopril) is indicated for the treatment of hypertension. in using capoten, consideration should be given to the risk of neutropenia/agranulocytosis (see precautions). capoten is effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. the blood pressure lowering effects of captopril and thiazides are approximately additive. 2. myocardial infarction: capoten is indicated to improve survival following myocardial infarction in clinically stable patients with left ventricular dysfunction manifested as an ejection fraction less than or equal to 40%, and to reduce the incidence of overt heart failure and subsequent hospitalisations for congestive heart failure in these patients. the efficacy data for the use of captopril following myocardial infarction are strongest for initiation of therapy beyond 3 days post-infarct. 3. heart failure: capoten (captopril) is indicated for the treatment of heart failure. in symptomatic patients it is recom

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

inova pharmaceuticals (australia) pty ltd - prednisone, quantity: 25 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; magnesium stearate; gelatin; propyl hydroxybenzoate; maize starch; wheat starch - indications as at 26 march 1997 : wherever corticosteroid therapy is indicated.

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

inova pharmaceuticals (australia) pty ltd - prednisolone, quantity: 5 mg - tablet, uncoated - excipient ingredients: magnesium stearate; wheat starch; maize starch; propyl hydroxybenzoate; lactose monohydrate; gelatin - indications as at 26 march 1997 : wherever corticosteroid therapy is indicated.

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

inova pharmaceuticals (australia) pty ltd - prednisolone, quantity: 25 mg - tablet, uncoated - excipient ingredients: wheat starch; magnesium stearate; gelatin; lactose monohydrate; maize starch; propyl hydroxybenzoate - indications as at 26 march 1997 : wherever corticosteroid therapy is indicated.

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

avallon pharmaceuticals pty ltd - sildenafil citrate, quantity: 140.4 mg (equivalent: sildenafil, qty 100 mg) - tablet, uncoated - excipient ingredients: microcrystalline cellulose; copovidone; croscarmellose sodium; saccharin sodium; indigo carmine aluminium lake; calcium hydrogen phosphate; magnesium stearate - noumed sildenafil is indicated for the treatment of erectile dysfunction in adult males. noumed sildenafil is not indicated for use by women.

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

avallon pharmaceuticals pty ltd - sildenafil citrate, quantity: 70.2 mg (equivalent: sildenafil, qty 50 mg) - tablet, uncoated - excipient ingredients: indigo carmine aluminium lake; croscarmellose sodium; microcrystalline cellulose; calcium hydrogen phosphate; magnesium stearate; copovidone; saccharin sodium - noumed sildenafil is indicated for the treatment of erectile dysfunction in adult males. noumed sildenafil is not indicated for use by women.