Australien - engelska - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - amlodipine besilate, quantity: 13.87 mg (equivalent: amlodipine, qty 10 mg); atorvastatin calcium trihydrate, quantity: 10.85 mg (equivalent: atorvastatin, qty 10 mg) - tablet, film coated - excipient ingredients: calcium carbonate; colloidal anhydrous silica; hyprolose; magnesium stearate; pregelatinised maize starch; croscarmellose sodium; microcrystalline cellulose; polysorbate 80; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3000; indigo carmine aluminium lake - amlodipine/atorvastatin-as (amlodipine and atorvastatin) is indicated for patients in whom treatment with amlodipine and atorvastatin is appropriate at the doses presented.,the indications for amlodipine are:,1. hypertension: amlodipine is indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine, which has been used in combination with a thiazide diuretic, beta adrenoceptor blocking agent or an angiotensin converting enzyme inhibitor.,2. angina: amlodipine is indicated for the first line treatment of chronic stable angina. amlodipine may be used alone, as monotherapy or in combination with other antianginal drugs,the indications for atorvastatin are:,1. atorvastatin is indicated as an adjunct to diet for the treatment of patients with hypercholesterolaemia.,prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, and alcoholism) should be identified and treated.,2. atorvastatin is indicated in hypertensive patients with multiple risk factors for coronary heart disease (chd) which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic chd (see clinical trials, prevention of cardiovascular disease) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke.,these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

generic health pty ltd - teriflunomide, quantity: 14 mg - tablet, film coated - excipient ingredients: magnesium stearate; colloidal anhydrous silica; maize starch; lactose monohydrate; sodium starch glycollate type a; microcrystalline cellulose; hyprolose; titanium dioxide; macrogol 8000; hypromellose; purified talc; indigo carmine aluminium lake - teriflunomide tablets are indicated for the treatment of patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical relapses and to delay the progression of physical disability.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - lacosamide, quantity: 50 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; magnesium stearate; hyprolose; colloidal anhydrous silica; crospovidone; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black; lecithin; indigo carmine aluminium lake - lacosam tablets are indicated as: ? monotherapy in the treatment of partial seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older. ? add-on therapy in the treatment of partial seizures with or without secondary generalisation in patients with epilepsy aged 4 years and older. ? add-on therapy in the treatment of primary generalised tonic-clonic seizures in patients with idiopathic generalised epilepsy aged 4 years and older

Australien - engelska - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - lacosamide, quantity: 200 mg - tablet, film coated - excipient ingredients: hyprolose; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; crospovidone; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; lecithin; indigo carmine aluminium lake - lacosam tablets are indicated as: ? monotherapy in the treatment of partial seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older. ? add-on therapy in the treatment of partial seizures with or without secondary generalisation in patients with epilepsy aged 4 years and older. ? add-on therapy in the treatment of primary generalised tonic-clonic seizures in patients with idiopathic generalised epilepsy aged 4 years and older

Australien - engelska - Department of Health (Therapeutic Goods Administration)

generic health pty ltd - lacosamide, quantity: 50 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; colloidal anhydrous silica; crospovidone; magnesium stearate; hyprolose; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black; lecithin; indigo carmine aluminium lake - lacosamide lupin tablets are indicated as: ? monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older. ? add-on therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 4 years and older. ? add-on therapy in the treatment of primary generalised tonic-clonic seizures in patients with idiopathic generalised epilepsy aged 4 years and older.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

generic health pty ltd - lacosamide, quantity: 200 mg - tablet, film coated - excipient ingredients: hyprolose; microcrystalline cellulose; magnesium stearate; crospovidone; colloidal anhydrous silica; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; lecithin; indigo carmine aluminium lake - lacosamide lupin tablets are indicated as: ? monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older. ? add-on therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 4 years and older. ? add-on therapy in the treatment of primary generalised tonic-clonic seizures in patients with idiopathic generalised epilepsy aged 4 years and older.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - linagliptin, quantity: 5 mg; empagliflozin, quantity: 25 mg - tablet, film coated - excipient ingredients: purified talc; hypromellose; mannitol; crospovidone; titanium dioxide; magnesium stearate; copovidone; pregelatinised maize starch; macrogol 6000; iron oxide red; maize starch - glyxambi tablets are indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate (see sections 4.2 dose and method of administration and 5.1 pharmacodynamic properties ? clinical trials).

Australien - engelska - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - empagliflozin, quantity: 10 mg; linagliptin, quantity: 5 mg - tablet, film coated - excipient ingredients: iron oxide yellow; macrogol 6000; hypromellose; crospovidone; maize starch; titanium dioxide; mannitol; purified talc; pregelatinised maize starch; copovidone; magnesium stearate - glyxambi tablets are indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate (see sections 4.2 dose and method of administration and 5.1 pharmacodynamic properties ? clinical trials).

Australien - engelska - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - afatinib dimaleate, quantity: 73.9 mg - tablet, film coated - excipient ingredients: purified talc; polysorbate 80; indigo carmine aluminium lake; colloidal anhydrous silica; magnesium stearate; lactose monohydrate; macrogol 400; hypromellose; microcrystalline cellulose; titanium dioxide; crospovidone - giotrif is indicated as monotherapy for the treatment of adult patients with:,? locally advanced or metastatic non-squamous non-small cell carcinoma of the lung, either as first line therapy or after failure of cytotoxic chemotherapy. tumours must have activating epidermal growth factor receptor (egfr) mutations.,? locally advanced or metastatic squamous non-small cell carcinoma of the lung progressing on or after platinum-based chemotherapy.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - afatinib dimaleate, quantity: 44.34 mg - tablet, film coated - excipient ingredients: crospovidone; titanium dioxide; polysorbate 80; lactose monohydrate; macrogol 400; colloidal anhydrous silica; microcrystalline cellulose; hypromellose; magnesium stearate; purified talc; indigo carmine aluminium lake - giotrif is indicated as monotherapy for the treatment of adult patients with:,? locally advanced or metastatic non-squamous non-small cell carcinoma of the lung, either as first line therapy or after failure of cytotoxic chemotherapy. tumours must have activating epidermal growth factor receptor (egfr) mutations.,? locally advanced or metastatic squamous non-small cell carcinoma of the lung progressing on or after platinum-based chemotherapy.