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

organon pharma pty ltd - atorvastatin calcium trihydrate, quantity: 86.8 mg (equivalent: atorvastatin, qty 80 mg); ezetimibe, quantity: 10 mg - tablet, multilayer - excipient ingredients: lactose monohydrate; sodium lauryl sulfate; magnesium stearate; croscarmellose sodium; microcrystalline cellulose; calcium carbonate; polysorbate 80; povidone; hyprolose; silicon dioxide; titanium dioxide; macrogol 8000; hypromellose; purified talc - prevention of cardiovascular disease atozet is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of atorvastatin and in need of additional lowering of ldl-c in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy (see clinical trials). primary hypercholesterolaemia atozet is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate in those patients: - not appropriately controlled with atorvastatin or ezetimibe alone; - or already treated with atorvastatin and ezetimibe homozygous familial hypercholesterolaemia (hofh) atozet is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g. ldl apheresis).

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

organon pharma pty ltd - atorvastatin calcium trihydrate, quantity: 10.9 mg (equivalent: atorvastatin, qty 10 mg); ezetimibe, quantity: 10 mg - tablet, multilayer - excipient ingredients: hyprolose; povidone; microcrystalline cellulose; magnesium stearate; silicon dioxide; lactose monohydrate; croscarmellose sodium; calcium carbonate; sodium lauryl sulfate; polysorbate 80; titanium dioxide; macrogol 8000; hypromellose; purified talc - prevention of cardiovascular disease atozet is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of atorvastatin and in need of additional lowering of ldl-c in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy (see clinical trials).,primary hypercholesterolaemia atozet is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate in those patients: - not appropriately controlled with atorvastatin or ezetimibe alone; - or already treated with atorvastatin and ezetimibe,homozygous familial hypercholesterolaemia (hofh) atozet is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g. ldl apheresis).

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

organon pharma pty ltd - ezetimibe, quantity: 10 mg; atorvastatin calcium trihydrate, quantity: 43.4 mg (equivalent: atorvastatin, qty 40 mg) - tablet, multilayer - excipient ingredients: hyprolose; lactose monohydrate; croscarmellose sodium; silicon dioxide; magnesium stearate; microcrystalline cellulose; povidone; polysorbate 80; sodium lauryl sulfate; calcium carbonate; titanium dioxide; macrogol 8000; hypromellose; purified talc - prevention of cardiovascular disease atozet is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of atorvastatin and in need of additional lowering of ldl-c in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy (see clinical trials). primary hypercholesterolaemia atozet is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate in those patients: - not appropriately controlled with atorvastatin or ezetimibe alone; - or already treated with atorvastatin and ezetimibe homozygous familial hypercholesterolaemia (hofh) atozet is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g. ldl apheresis).

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

organon pharma pty ltd - atorvastatin calcium trihydrate, quantity: 21.7 mg (equivalent: atorvastatin, qty 20 mg); ezetimibe, quantity: 10 mg - tablet, multilayer - excipient ingredients: lactose monohydrate; croscarmellose sodium; microcrystalline cellulose; calcium carbonate; polysorbate 80; sodium lauryl sulfate; silicon dioxide; povidone; magnesium stearate; hyprolose; titanium dioxide; macrogol 8000; hypromellose; purified talc - prevention of cardiovascular disease atozet is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of atorvastatin and in need of additional lowering of ldl-c in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy (see clinical trials). primary hypercholesterolaemia atozet is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate in those patients: - not appropriately controlled with atorvastatin or ezetimibe alone; - or already treated with atorvastatin and ezetimibe homozygous familial hypercholesterolaemia (hofh) atozet is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g. ldl apheresis).

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

merck sharp & dohme (australia) pty ltd - posaconazole, quantity: 100 mg - tablet, modified release - excipient ingredients: hypromellose acetate succinate; microcrystalline cellulose; hyprolose; silicon dioxide; croscarmellose sodium; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - noxafil (posaconazole) is indicated for use in the treatment of the following invasive fungal infections in patients 13 years of age or older; invasive aspergillosis in patients intolerant of, or with disease that is refractory to, alternative therapy; fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, and mycetoma in patients intolerant of, or with disease that is refractory to, alternative therapy. noxafil is also indicated for the: treatment of oropharyngeal candidiasis in immunocompromised adults, including patients with disease that is refractory to itraconazole and fluconazole. prophylaxis of invasive fungal infections, among patients 13 years of age and older, who are at high risk of developing these infections, such as patients with prolonged neutropenia or haematopoietic stem cell transplant (hsct) recipients.

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

astrazeneca pty ltd - saxagliptin, quantity: 2.5 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; magnesium stearate; lactose monohydrate; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; indigo carmine aluminium lake; ethanol; shellac; sulfuric acid; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - add-on combination: onglyza is indicated in patients with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicines, when these together with diet and exercise, do not provide adequate glycaemic control (see clinical trials and precautions for available data on different add-on combination therapies).,initial combination: onglyza is indicated for use as initial combination therapy with metformin, in patients with type 2 diabetes mellitus, to improve glycaemic control as an adjunct to diet and exercise, when dual saxagliptin and metformin therapy is appropriate (i.e. high initial hba1c levels and poor prospects for response to monotherapy).

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

merck sharp & dohme (australia) pty ltd - suvorexant, quantity: 20 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; copovidone; magnesium stearate; croscarmellose sodium; titanium dioxide; hypromellose; triacetin - belsomra is indicated for the treatment of insomnia, characterised by difficulties with sleep onset and/or sleep maintenance. following initiation of treatment, continuation should be re-evaluated after 3 months [see pharmacodynamic properties, clinical trials and adverse effects (undesirable effects) for clinical trial durations].

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

merck sharp & dohme (australia) pty ltd - suvorexant, quantity: 15 mg - tablet, film coated - excipient ingredients: lactose monohydrate; magnesium stearate; copovidone; microcrystalline cellulose; croscarmellose sodium; titanium dioxide; hypromellose; triacetin - belsomra is indicated for the treatment of insomnia, characterised by difficulties with sleep onset and/or sleep maintenance.,following initiation of treatment, continuation should be re-evaluated after 3 months [see pharmacodynamic properties, clinical trials and adverse effects (undesirable effects) for clinical trial durations].

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

merck sharp & dohme (australia) pty ltd - metformin hydrochloride, quantity: 1000 mg; sitagliptin phosphate monohydrate, quantity: 128.5 mg (equivalent: sitagliptin, qty 100 mg) - tablet, modified release - excipient ingredients: povidone; hypromellose; colloidal anhydrous silica; sodium stearylfumarate; propyl gallate; macrogol 3350; kaolin; carnauba wax; titanium dioxide; hyprolose; indigo carmine aluminium lake - janumet xr (sitagliptin phosphate monohydrate and metformin hydrochloride) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate.,[see sections 5.1 pharmacodynamic properties, clinical trials and 4.2 dose and method of administration].

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

merck sharp & dohme (australia) pty ltd - metformin hydrochloride, quantity: 1000 mg; sitagliptin phosphate monohydrate, quantity: 64.25 mg (equivalent: sitagliptin, qty 50 mg) - tablet, modified release - excipient ingredients: povidone; hypromellose; colloidal anhydrous silica; sodium stearylfumarate; propyl gallate; macrogol 3350; kaolin; carnauba wax; titanium dioxide; hyprolose; iron oxide yellow; indigo carmine aluminium lake - janumet xr (sitagliptin phosphate monohydrate and metformin hydrochloride) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate.,[see sections 5.1 pharmacodynamic properties, clinical trials and 4.2 dose and method of administration].