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

medis pharma pty ltd - ezetimibe, quantity: 10 mg; simvastatin, quantity: 80 mg - tablet - excipient ingredients: butylated hydroxyanisole; iron oxide yellow; croscarmellose sodium; iron oxide black; magnesium stearate; iron oxide red; citric acid; lactose monohydrate; propyl gallate; hypromellose; ascorbic acid; microcrystalline cellulose - adults (?18 years),prevention of cardiovascular disease ezetimibe/simvastatin-medis 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 clinical trials).,primary hypercholesterolaemia ezetimibe/simvastatin-medis 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) ezetimibe/simvastatin-medis is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g., 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) ezetimibe/simvastatin-medis is indicated as 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/simvastatin-medis is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

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

medis pharma pty ltd - ezetimibe, quantity: 10 mg; simvastatin, quantity: 20 mg - tablet - excipient ingredients: lactose monohydrate; butylated hydroxyanisole; propyl gallate; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; iron oxide black; hypromellose; iron oxide red; citric acid; iron oxide yellow; ascorbic acid - adults (?18 years),prevention of cardiovascular disease ezetimibe/simvastatin-medis 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 clinical trials).,primary hypercholesterolaemia ezetimibe/simvastatin-medis 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) ezetimibe/simvastatin-medis is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g., 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) ezetimibe/simvastatin-medis is indicated as 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/simvastatin-medis is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

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

medis pharma pty ltd - ezetimibe, quantity: 10 mg; simvastatin, quantity: 80 mg - tablet - excipient ingredients: lactose monohydrate; magnesium stearate; butylated hydroxyanisole; ascorbic acid; iron oxide red; propyl gallate; iron oxide yellow; microcrystalline cellulose; hypromellose; citric acid; croscarmellose sodium; iron oxide black - adults (?18 years),prevention of cardiovascular disease ezetimibe/simvastatin-medis 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 clinical trials).,primary hypercholesterolaemia ezetimibe/simvastatin-medis 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) ezetimibe/simvastatin-medis is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g., 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) ezetimibe/simvastatin-medis is indicated as 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/simvastatin-medis is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

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

medis pharma pty ltd - ezetimibe, quantity: 10 mg; simvastatin, quantity: 40 mg - tablet - excipient ingredients: microcrystalline cellulose; iron oxide yellow; iron oxide black; croscarmellose sodium; propyl gallate; butylated hydroxyanisole; lactose monohydrate; hypromellose; iron oxide red; citric acid; ascorbic acid; magnesium stearate - adults (?18 years),prevention of cardiovascular disease ezetimibe/simvastatin-medis 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 clinical trials).,primary hypercholesterolaemia ezetimibe/simvastatin-medis 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) ezetimibe/simvastatin-medis is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g., 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) ezetimibe/simvastatin-medis is indicated as 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/simvastatin-medis is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

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

medis pharma pty ltd - ezetimibe, quantity: 10 mg; simvastatin, quantity: 10 mg - tablet - excipient ingredients: citric acid; lactose monohydrate; propyl gallate; magnesium stearate; iron oxide black; ascorbic acid; hypromellose; croscarmellose sodium; iron oxide yellow; microcrystalline cellulose; butylated hydroxyanisole; iron oxide red - adults (?18 years),prevention of cardiovascular disease ezetimibe/simvastatin-medis 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 clinical trials).,primary hypercholesterolaemia ezetimibe/simvastatin-medis 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) ezetimibe/simvastatin-medis is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g., 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) ezetimibe/simvastatin-medis is indicated as 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/simvastatin-medis is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

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

medis pharma pty ltd - simvastatin, quantity: 20 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: microcrystalline cellulose; iron oxide yellow; magnesium stearate; butylated hydroxyanisole; propyl gallate; lactose monohydrate; iron oxide black; iron oxide red; croscarmellose sodium; citric acid; hypromellose; ascorbic acid - adults (?18 years),prevention of cardiovascular disease ezetimibe/simvastatin-medis 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 clinical trials).,primary hypercholesterolaemia ezetimibe/simvastatin-medis 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) ezetimibe/simvastatin-medis is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g., 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) ezetimibe/simvastatin-medis is indicated as 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/simvastatin-medis is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

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

medis pharma pty ltd - esomeprazole magnesium dihydrate, quantity: 21.75 mg (equivalent: esomeprazole, qty 20 mg) - tablet, enteric coated - excipient ingredients: triethyl citrate; purified talc; hypromellose; sodium stearylfumarate; glyceryl monostearate; microcrystalline cellulose; hyprolose; methacrylic acid - ethyl acrylate copolymer (1:1); crospovidone; magnesium stearate; povidone; polysorbate 80; macrogol 6000; titanium dioxide; macrogol 400; iron oxide red; iron oxide yellow; maize starch; sucrose - it is indicated for:,gastro-oesophageal reflux disease (gord): treatment of erosive reflux oesophagitis, long-term management of patients with healed oesophagitis to prevent relapse and symptomatic treatment of gastro-oesophageal reflux disease (gord).,patients requiring nsaid therapy: short-term treatment of upper gastrointestinal symptoms associated with non-steroidal anti-inflammatory drug nsaid (non-selective and cox-2 selective) therapy, healing of gastric ulcers associated with non-steroidal anti-inflammatory drug nsaid (non-selective and cox-2 selective) therapy and prevention of gastric and duodenal ulcers associated with non-steroidal anti inflammatory drug nsaid (non-selective and cox-2 selective) therapy in patients at risk.,prevention of rebleeding of gastric or duodenal ulcers following treatment with iv esomeprazole solution by intravenous infusion (intravenous dosage form can be available from other brands).,pathological hypersecretory conditions including zollinger-ellison syndrome and idiopathic hypersecretion, in combination with appropriate antibiotics for: healing of duodenal ulcer associated with helicobacter pylori and eradication of helicobacter pylori in patients with active or healed peptic ulcer.

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

medis pharma pty ltd - esomeprazole magnesium dihydrate, quantity: 43.5 mg (equivalent: esomeprazole, qty 40 mg) - tablet, enteric coated - excipient ingredients: purified talc; hypromellose; crospovidone; polysorbate 80; magnesium stearate; glyceryl monostearate; hyprolose; macrogol 6000; sodium stearylfumarate; triethyl citrate; methacrylic acid - ethyl acrylate copolymer (1:1); povidone; microcrystalline cellulose; titanium dioxide; macrogol 400; iron oxide red; iron oxide yellow; maize starch; sucrose - it is indicated for:,gastro-oesophageal reflux disease (gord): treatment of erosive reflux oesophagitis, long-term management of patients with healed oesophagitis to prevent relapse and symptomatic treatment of gastro-oesophageal reflux disease (gord).,patients requiring nsaid therapy: short-term treatment of upper gastrointestinal symptoms associated with non-steroidal anti-inflammatory drug nsaid (non-selective and cox-2 selective) therapy, healing of gastric ulcers associated with non-steroidal anti-inflammatory drug nsaid (non-selective and cox-2 selective) therapy and prevention of gastric and duodenal ulcers associated with non-steroidal anti inflammatory drug nsaid (non-selective and cox-2 selective) therapy in patients at risk.,prevention of rebleeding of gastric or duodenal ulcers following treatment with iv esomeprazole solution by intravenous infusion (intravenous dosage form can be available from other brands).,pathological hypersecretory conditions including zollinger-ellison syndrome and idiopathic hypersecretion, in combination with appropriate antibiotics for: healing of duodenal ulcer associated with helicobacter pylori and eradication of helicobacter pylori in patients with active or healed peptic ulcer.

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

medis pharma pty ltd - esomeprazole magnesium dihydrate -

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

medis pharma pty ltd - esomeprazole magnesium dihydrate -