Australia - English - Department of Health (Therapeutic Goods Administration)

torrent australasia pty ltd - ezetimibe, quantity: 10 mg; simvastatin, quantity: 80 mg - tablet - excipient ingredients: citric acid monohydrate; hypromellose; croscarmellose sodium; butylated hydroxyanisole; propyl gallate; lactose monohydrate; microcrystalline cellulose; magnesium stearate; ferric oxide; ascorbic acid - adults (greater than or equal to 18 years),prevention of cardiovascular disease,ezsimva gh is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of simvastatin 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 section 5.1 pharmacodynamic properties - clinical trials),primary hypercholesterolaemia,ezsimva gh is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia 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),ezsimva gh s is indicated in patients with hofh. patients may also receive adjunctive treatments (eg. ldl apheresis).,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),ezsimva gh is indicated as adjunctive therapy to diet in adolescent patients (10-17 years old) with hefh 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),ezsimva gh is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (eg. ldl apheresis).

Australia - English - Department of Health (Therapeutic Goods Administration)

torrent australasia pty ltd - simvastatin, quantity: 10 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: croscarmellose sodium; ascorbic acid; microcrystalline cellulose; citric acid monohydrate; lactose monohydrate; butylated hydroxyanisole; propyl gallate; magnesium stearate; ferric oxide; hypromellose - adults (greater than or equal to 18 years),prevention of cardiovascular disease,ezsimva gh is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of simvastatin 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 section 5.1 pharmacodynamic properties - clinical trials),primary hypercholesterolaemia,ezsimva gh is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia 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),ezsimva gh s is indicated in patients with hofh. patients may also receive adjunctive treatments (eg. ldl apheresis).,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),ezsimva gh is indicated as adjunctive therapy to diet in adolescent patients (10-17 years old) with hefh 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),ezsimva gh is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (eg. ldl apheresis).

Australia - English - Department of Health (Therapeutic Goods Administration)

torrent australasia pty ltd - simvastatin, quantity: 40 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: butylated hydroxyanisole; croscarmellose sodium; microcrystalline cellulose; ascorbic acid; lactose monohydrate; citric acid monohydrate; hypromellose; ferric oxide; propyl gallate; magnesium stearate - adults (greater than or equal to 18 years),prevention of cardiovascular disease,ezsimva gh is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of simvastatin 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 section 5.1 pharmacodynamic properties - clinical trials),primary hypercholesterolaemia,ezsimva gh is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia 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),ezsimva gh s is indicated in patients with hofh. patients may also receive adjunctive treatments (eg. ldl apheresis).,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),ezsimva gh is indicated as adjunctive therapy to diet in adolescent patients (10-17 years old) with hefh 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),ezsimva gh is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (eg. ldl apheresis).

Australia - English - Department of Health (Therapeutic Goods Administration)

torrent australasia pty ltd - simvastatin, quantity: 20 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: croscarmellose sodium; lactose monohydrate; citric acid monohydrate; magnesium stearate; propyl gallate; hypromellose; microcrystalline cellulose; ferric oxide; ascorbic acid; butylated hydroxyanisole - adults (greater than or equal to 18 years),prevention of cardiovascular disease,ezsimva gh is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of simvastatin 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 section 5.1 pharmacodynamic properties - clinical trials),primary hypercholesterolaemia,ezsimva gh is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia 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),ezsimva gh s is indicated in patients with hofh. patients may also receive adjunctive treatments (eg. ldl apheresis).,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),ezsimva gh is indicated as adjunctive therapy to diet in adolescent patients (10-17 years old) with hefh 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),ezsimva gh is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (eg. ldl apheresis).

Australia - English - Department of Health (Therapeutic Goods Administration)

generic health pty ltd - raloxifene hydrochloride, quantity: 60 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; poloxamer; calcium hydrogen phosphate dihydrate; citric acid monohydrate; sodium starch glycollate; magnesium stearate; titanium dioxide; lactose monohydrate; hypromellose; macrogol 4000 - raloxifene gh is proposed to be used for:,1. the prevention and treatment of osteoprosis in post-menopausal women,2. the reduction in the risk of invasive breast cancer in postmenopausal women with osteoporosis,3. the reduction in the risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer,high risk of breast cancer is defined as at least one breast biopsy showing lobular carcinoma in situ (lcis) or atypical hyperplasia, one or more first-degree relatives with breast cancer, or a 5-year predicted risk of breast cancer >1.66% (based on the modified gail model). among the factors included in the modified gail model are the following: current age, number of first-degree relatives with breast cancer, number of breast biopsies, age at menarche, nulliparity or age of first live birth. currently, no single clinical finding or test result can quantify risk of breast cancer with certainty.

Australia - English - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - imatinib mesilate, quantity: 478 mg (equivalent: imatinib, qty 400 mg) - capsule - excipient ingredients: magnesium stearate; lactose; colloidal anhydrous silica; crospovidone; titanium dioxide; purified water; iron oxide yellow; iron oxide red; gelatin; sodium lauryl sulfate - imatinib gh is indicated for the: ? treatment of patients with chronic myeloid leukaemia (cml) ? treatment of adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy ? treatment of adult patients with relapsed or refractory ph+ all as monotherapy ? treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements, where conventional therapies have failed ? treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed ? treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) ? adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

Australia - English - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - imatinib mesilate, quantity: 119.5 mg (equivalent: imatinib, qty 100 mg) - capsule - excipient ingredients: colloidal anhydrous silica; lactose; magnesium stearate; crospovidone; titanium dioxide; purified water; iron oxide yellow; iron oxide red; gelatin; sodium lauryl sulfate - imatinib gh is indicated for the: ? treatment of patients with chronic myeloid leukaemia (cml) ? treatment of adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy ? treatment of adult patients with relapsed or refractory ph+ all as monotherapy ? treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements, where conventional therapies have failed ? treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed ? treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) ? adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

Australia - English - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - lamotrigine, quantity: 200 mg - tablet, uncoated - excipient ingredients: magnesium stearate; microcrystalline cellulose; sodium starch glycollate; maize starch; lactose monohydrate - lamotrigine gh (lamotrigine) is an anti-epileptic drug for the treatment of partial and generalised seizures in adults and children over 12 years of age.,there is extensive experience with lamotrigine used initially as ?add-on therapy?. the use of lamotrigine has also been found to be effective as monotherapy following withdrawal of concomitant anti-epileptic drugs (aeds).,initial monotherapy treatment in newly diagnosed paediatric patients is not recommended (see section 5.1 pharmacodynamic properties - clinical trials).

Australia - English - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - lamotrigine, quantity: 100 mg - tablet, uncoated - excipient ingredients: magnesium stearate; sodium starch glycollate; maize starch; lactose monohydrate; microcrystalline cellulose - lamotrigine gh (lamotrigine) is an anti-epileptic drug for the treatment of partial and generalised seizures in adults and children over 12 years of age.,there is extensive experience with lamotrigine used initially as ?add-on therapy?. the use of lamotrigine has also been found to be effective as monotherapy following withdrawal of concomitant anti-epileptic drugs (aeds).,initial monotherapy treatment in newly diagnosed paediatric patients is not recommended (see section 5.1 pharmacodynamic properties - clinical trials).

Australia - English - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - lamotrigine, quantity: 50 mg - tablet, uncoated - excipient ingredients: sodium starch glycollate; microcrystalline cellulose; lactose monohydrate; maize starch; magnesium stearate - lamotrigine gh (lamotrigine) is an anti-epileptic drug for the treatment of partial and generalised seizures in adults and children over 12 years of age.,there is extensive experience with lamotrigine used initially as ?add-on therapy?. the use of lamotrigine has also been found to be effective as monotherapy following withdrawal of concomitant anti-epileptic drugs (aeds).,initial monotherapy treatment in newly diagnosed paediatric patients is not recommended (see section 5.1 pharmacodynamic properties - clinical trials).