オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - ezetimibe, quantity: 10 mg - tablet - excipient ingredients: hypromellose; lactose monohydrate; sodium lauryl sulfate; magnesium stearate; croscarmellose sodium; microcrystalline cellulose - adults (? 18 years),primary hypercholesterolaemia,ezetimibe administered alone, or with an hmg-coa reductase inhibitor (statin), is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia.,homozygous familial hypercholesterolaemia (hofh),ezetimibe, administered with a statin, is indicated for patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).,homozygous sitosterolaemia (phytosterolaemia),ezetimibe, is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia.,prevention of cardiovascular disease,ezetimibe, is indicated for administration in combination with the maximum tolerated dose of a statin with proven cardiovascular benefit in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) in need of additional lowering of ldl-c in the expectation of a modest further reduction in risk of cardiovascular events following at least one year therapy (see section 5.1 pharmacodynamic properties, clinical trials),children and adolescents 10-17 years,(pubertal status: boys tanner stage ii and above and girls who are at least one year post-menarche),heterozygous familial hypercholesterolaemia (hefh),ezetimibe co-administered with simvastatin (doses up to 40 mg) is indicated as an adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia where use of a combination product is appropriate:,? patients not appropriately controlled with a statin or ezetimibe alone ? patients already treated with a statin and ezetimibe,homozygous familial hypercholesterolaemia (hofh),ezetimibe co-administered with simvastatin (doses up to 40 mg) is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g. ldl apheresis)

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - ezetimibe, quantity: 10 mg - tablet - excipient ingredients: hypromellose; lactose monohydrate; sodium lauryl sulfate; magnesium stearate; croscarmellose sodium; microcrystalline cellulose - adults (? 18 years),primary hypercholesterolaemia,ezetimibe administered alone, or with an hmg-coa reductase inhibitor (statin), is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia.,homozygous familial hypercholesterolaemia (hofh),ezetimibe, administered with a statin, is indicated for patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).,homozygous sitosterolaemia (phytosterolaemia),ezetimibe, is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia.,prevention of cardiovascular disease,ezetimibe, is indicated for administration in combination with the maximum tolerated dose of a statin with proven cardiovascular benefit in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) in need of additional lowering of ldl-c in the expectation of a modest further reduction in risk of cardiovascular events following at least one year therapy (see section 5.1 pharmacodynamic properties, clinical trials),children and adolescents 10-17 years,(pubertal status: boys tanner stage ii and above and girls who are at least one year post-menarche),heterozygous familial hypercholesterolaemia (hefh),ezetimibe co-administered with simvastatin (doses up to 40 mg) is indicated as an adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia where use of a combination product is appropriate:,? patients not appropriately controlled with a statin or ezetimibe alone ? patients already treated with a statin and ezetimibe,homozygous familial hypercholesterolaemia (hofh),ezetimibe co-administered with simvastatin (doses up to 40 mg) is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g. ldl apheresis)

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

viatris pty ltd - betahistine dihydrochloride, quantity: 16 mg - tablet, uncoated - excipient ingredients: colloidal anhydrous silica; microcrystalline cellulose; mannitol; citric acid monohydrate; purified talc - meniere's syndrome as defined by the following core symptoms: - vertigo (with nausea/vomiting): - hearing loss (hardness of hearing): - tinnitus.

シンガポール - 英語 - HSA (Health Sciences Authority)

bayer (south east asia) pte ltd - (tablet core, product) drospirenone; (tablet core, product) ethinylestradiol betadex clathrate - tablet, film coated - 3.000 mg - (tablet core, product) drospirenone 3.000 mg; (tablet core, product) ethinylestradiol betadex clathrate 0.020 mg

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - dosulepin (dothiepin) hydrochloride, quantity: 75 mg - tablet, film coated - excipient ingredients: povidone; maize starch; sodium starch glycollate; lactose monohydrate; purified talc; magnesium stearate; titanium dioxide; xanthan gum; polyvinyl alcohol; brilliant scarlet 4r; lecithin - the 75mg tablets are indicated only for the maintenance treatment of major depression. (see precautions).

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

aspen pharmacare australia pty ltd - paracetamol, quantity: 325 mg; tramadol hydrochloride, quantity: 37.5 mg - tablet, film coated - excipient ingredients: powdered cellulose; magnesium stearate; macrogol 6000; sodium starch glycollate type a; titanium dioxide; hypromellose; pregelatinised maize starch; purified talc; iron oxide yellow; lactose monohydrate; maize starch; propylene glycol - zaldiar is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - metformin hydrochloride, quantity: 500 mg - tablet, modified release - excipient ingredients: povidone; colloidal anhydrous silica; hypromellose; magnesium stearate - treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. metformin modified release tablets may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin.

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - metformin hydrochloride, quantity: 1000 mg - tablet, modified release - excipient ingredients: povidone; colloidal anhydrous silica; hypromellose; magnesium stearate - treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. metformin modified release tablets may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin.

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

gm pharma international pty ltd - metformin hydrochloride, quantity: 500 mg - tablet, modified release - excipient ingredients: povidone; colloidal anhydrous silica; hypromellose; magnesium stearate - treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. metformin modified release tablets may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin.

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

gm pharma international pty ltd - metformin hydrochloride, quantity: 1000 mg - tablet, modified release - excipient ingredients: povidone; colloidal anhydrous silica; hypromellose; magnesium stearate - treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. metformin modified release tablets may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin.