Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

mayne pharma international pty ltd - estetrol monohydrate, quantity: 15 mg (equivalent: estetrol, qty 14.2 mg); drospirenone, quantity: 3 mg - tablet, film coated - excipient ingredients: magnesium stearate; titanium dioxide; hypromellose; hyprolose; purified talc; hydrogenated cottonseed oil; lactose monohydrate; maize starch - nextstellis is indicated for use by women of reproductive potential to prevent pregnancy.

Austrālija - angļu - 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). .

Austrālija - angļu - 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).

Austrālija - angļu - 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.

Austrālija - angļu - 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.

Austrālija - angļu - 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.

Austrālija - angļu - 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.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

viatris pty ltd - fenofibrate, quantity: 48 mg - tablet - excipient ingredients: microcrystalline cellulose; sodium lauryl sulfate; lactose monohydrate; sucrose; hypromellose; docusate sodium; magnesium stearate; colloidal anhydrous silica; crospovidone; titanium dioxide; sunset yellow fcf aluminium lake; purified talc; xanthan gum; polyvinyl alcohol; quinoline yellow aluminium lake; lecithin; indigo carmine aluminium lake - fenofibrate viatris is indicated as an adjunct to diet in the treatment of: - hypercholesterolaemia; - types ii, iii, iv and v dyslipidaemia; - dyslipidaemia associated with type 2 diabetes.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

viatris pty ltd - fenofibrate, quantity: 145 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; sodium lauryl sulfate; crospovidone; hypromellose; magnesium stearate; lactose monohydrate; docusate sodium; microcrystalline cellulose; sucrose; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin - fenofibrate viatris is indicated as an adjunct to diet in the treatment of: - hypercholesterolaemia; - types ii, iii, iv and v dyslipidaemia; - dyslipidaemia associated with type 2 diabetes.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

gm pharma international pty ltd - hydroxychloroquine sulfate, quantity: 200 mg - tablet - excipient ingredients: colloidal anhydrous silica; pregelatinised maize starch; magnesium stearate; hypromellose; polysorbate 80; calcium hydrogen phosphate; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - rheumatoid arthritis; mild systemic and discoid lupus erythematosus; the suppression and treatment of malaria.