Australië - Engels - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - ibrutinib, quantity: 280 mg - tablet, film coated - excipient ingredients: lactose monohydrate; croscarmellose sodium; sodium lauryl sulfate; povidone; microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - imbruvica is indicated for the treatment of patients with mcl who have received at least one prior therapy.,imbruvica as a single agent is indicated for the treatment of adult patients with waldenstr?m?s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.,imbruvica in combination with rituximab is indicated for the treatment of adult patients with waldenstrom?s macroglobulinaemia (wm).,imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia/small lymphocytic lymphoma (cll/sll).,imbruvica as a single agent or in combination with bendamustine and rituximab (br) is indicated for the treatment of adult patients with chronic lymphocytic leukaemia/small lymphocytic lymphoma (cll/sll) who have received at least one prior therapy.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - ibrutinib, quantity: 140 mg - tablet, film coated - excipient ingredients: lactose monohydrate; croscarmellose sodium; sodium lauryl sulfate; povidone; microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; iron oxide black - imbruvica is indicated for the treatment of patients with mcl who have received at least one prior therapy.,imbruvica as a single agent is indicated for the treatment of adult patients with waldenstr?m?s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.,imbruvica in combination with rituximab is indicated for the treatment of adult patients with waldenstrom?s macroglobulinaemia (wm).,imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia/small lymphocytic lymphoma (cll/sll).,imbruvica as a single agent or in combination with bendamustine and rituximab (br) is indicated for the treatment of adult patients with chronic lymphocytic leukaemia/small lymphocytic lymphoma (cll/sll) who have received at least one prior therapy.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - voriconazole, quantity: 50 mg - tablet, film coated - excipient ingredients: povidone; croscarmellose sodium; lactose monohydrate; magnesium stearate; pregelatinised maize starch; titanium dioxide; hypromellose; triacetin - voriconazole sandoz is indicated for treatment of the following fungal infections:,- invasive aspergillosis.,- serious candida infections (including c. krusei), including oesophageal and systemic candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia).,- serious fungal infections caused by scedosporium spp and fusarium spp.,- other serious fungal infections, in patients intolerant of, or refractory to, other therapy,- prophylaxis in patients who are at high risk of developing invasive fungal infections. the indication is based on studies including patients undergoing haematopoietic stem cell transplantation.,- this brand is only available as tablets and therefore only indicated for adults and children 12 years or older who can tolerate tablets. for dosing requirements for populations who require intravenous or oral suspension treatment see dosage and administration.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - voriconazole, quantity: 200 mg - tablet, film coated - excipient ingredients: pregelatinised maize starch; lactose monohydrate; povidone; croscarmellose sodium; magnesium stearate; titanium dioxide; hypromellose; triacetin - voriconazole sandoz is indicated for treatment of the following fungal infections:,- invasive aspergillosis.,- serious candida infections (including c. krusei), including oesophageal and systemic candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia).,- serious fungal infections caused by scedosporium spp and fusarium spp.,- other serious fungal infections, in patients intolerant of, or refractory to, other therapy,- prophylaxis in patients who are at high risk of developing invasive fungal infections. the indication is based on studies including patients undergoing haematopoietic stem cell transplantation.,- this brand is only available as tablets and therefore only indicated for adults and children 12 years or older who can tolerate tablets. for dosing requirements for populations who require intravenous or oral suspension treatment see dosage and administration.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - sildenafil citrate, quantity: 35.125 mg (equivalent: sildenafil, qty 25 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; hypromellose; magnesium stearate; calcium hydrogen phosphate; microcrystalline cellulose; titanium dioxide; lactose monohydrate; triacetin; indigo carmine aluminium lake - indicated for the treatment of erectile dysfunction in adult males. sildenafil citrate 25 mg tablets is not indicated for use by women.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - sildenafil citrate, quantity: 140.5 mg (equivalent: sildenafil, qty 100 mg) - tablet, film coated - excipient ingredients: hypromellose; calcium hydrogen phosphate; croscarmellose sodium; magnesium stearate; microcrystalline cellulose; titanium dioxide; lactose monohydrate; triacetin; indigo carmine aluminium lake - indicated for the treatment of erectile dysfunction in adult males. sildenafil citrate 100 mg tablets is not indicated for use by women.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - sildenafil citrate, quantity: 70.25 mg (equivalent: sildenafil, qty 50 mg) - tablet, film coated - excipient ingredients: hypromellose; calcium hydrogen phosphate; magnesium stearate; microcrystalline cellulose; croscarmellose sodium; titanium dioxide; lactose monohydrate; triacetin; indigo carmine aluminium lake - indicated for the treatment of erectile dysfunction in adult males. sildenafil citrate 50 mg tablets is not indicated for use by women.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - amlodipine besilate, quantity: 13.87 mg; atorvastatin calcium trihydrate, quantity: 86.8 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-medis (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.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - amlodipine besilate, quantity: 13.87 mg; atorvastatin calcium trihydrate, quantity: 43.4 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-medis (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.

Australië - Engels - 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: 21.7 mg (equivalent: atorvastatin, qty 20 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-medis (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.