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

cipla australia pty ltd - lacosamide, quantity: 100 mg - tablet, film coated - excipient ingredients: magnesium stearate; colloidal anhydrous silica; hyprolose; crospovidone; microcrystalline cellulose; titanium dioxide; hypromellose; purified talc; iron oxide yellow; macrogol 6000; macrogol 400 - lacoress (lacosamide) tablets are indicated as: ? monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older. ? add-on therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 4 years and older. ? add-on therapy in the treatment of primary generalised tonic-clonic seizures in patients with idiopathic generalised epilepsy aged 4 years and older.

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

cipla australia pty ltd - lacosamide, quantity: 200 mg - tablet, film coated - excipient ingredients: hyprolose; crospovidone; magnesium stearate; colloidal anhydrous silica; microcrystalline cellulose; titanium dioxide; hypromellose; purified talc; macrogol 6000; macrogol 400; indigo carmine aluminium lake - lacoress (lacosamide) tablets are indicated as: ? monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older. ? add-on therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 4 years and older. ? add-on therapy in the treatment of primary generalised tonic-clonic seizures in patients with idiopathic generalised epilepsy aged 4 years and older.

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

cipla australia pty ltd - lacosamide, quantity: 150 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; hyprolose; crospovidone; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; purified talc; iron oxide yellow; macrogol 6000; iron oxide red; iron oxide black; macrogol 400 - lacoress (lacosamide) tablets are indicated as: ? monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older. ? add-on therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 4 years and older. ? add-on therapy in the treatment of primary generalised tonic-clonic seizures in patients with idiopathic generalised epilepsy aged 4 years and older.

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

cipla australia pty ltd - lacosamide, quantity: 50 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; hyprolose; colloidal anhydrous silica; crospovidone; magnesium stearate; titanium dioxide; hypromellose; purified talc; macrogol 6000; iron oxide red; iron oxide black; macrogol 400; indigo carmine aluminium lake - lacoress (lacosamide) tablets are indicated as: ? monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older. ? add-on therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 4 years and older. ? add-on therapy in the treatment of primary generalised tonic-clonic seizures in patients with idiopathic generalised epilepsy aged 4 years and older.

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

astrazeneca pty ltd - acalabrutinib maleate monohydrate, quantity: 129 mg - tablet, film coated - excipient ingredients: mannitol; microcrystalline cellulose; hyprolose; sodium stearylfumarate; hypromellose; copovidone; titanium dioxide; macrogol 3350; medium chain triglycerides; iron oxide yellow; iron oxide red - calquence is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.,this indication is approved via the provisional approval pathway, based on overall response rate. full registration for this indication depends on verification and description of clinical benefit in confirmatory trials. calquence is indicated for the treatment of patients with chronic lymphocytic leukaemia (cll)/small lymphocytic lymphoma (sll).

アイルランド - 英語 - HPRA (Health Products Regulatory Authority)

le vet beheer b.v. - thiamazole - film-coated tablet - 5 mg/tablet - thiamazole - cats - miscellaneous

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

boehringer ingelheim pty ltd - linagliptin, quantity: 2.5 mg; metformin hydrochloride, quantity: 850 mg - tablet, film coated - excipient ingredients: hypromellose; purified talc; colloidal anhydrous silica; magnesium stearate; copovidone; propylene glycol; titanium dioxide; arginine; iron oxide yellow; maize starch; iron oxide red - trajentamet is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin and metformin is appropriate, in patients inadequately controlled on metformin alone, or those already being treated and well controlled with the free combination of linagliptin and metformin. trajentamet is indicated in combination with a sulfonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulfonylurea. trajentamet is indicated in combination with an sglt2 inhibitor (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximum tolerated dose of metformin and an sglt2 inhibitor. trajentamet is indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when insulin and metformin alone do not provide adequate glycaemic control.

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

boehringer ingelheim pty ltd - linagliptin, quantity: 2.5 mg; metformin hydrochloride, quantity: 850 mg - tablet, film coated - excipient ingredients: arginine; magnesium stearate; purified talc; copovidone; maize starch; iron oxide yellow; titanium dioxide; colloidal anhydrous silica; hypromellose; propylene glycol; iron oxide red - trajentamet is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin and metformin is appropriate, in patients inadequately controlled on metformin alone, or those already being treated and well controlled with the free combination of linagliptin and metformin. trajentamet is indicated in combination with a sulfonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulfonylurea. trajentamet is indicated in combination with an sglt2 inhibitor (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximum tolerated dose of metformin and an sglt2 inhibitor. trajentamet is indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when insulin and metformin alone do not provide adequate glycaemic control.

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

sandoz pty ltd - clopidogrel hydrogen sulfate, quantity: 97.875 mg (equivalent: clopidogrel, qty 75 mg) - tablet, film coated - excipient ingredients: hydrogenated castor oil; colloidal anhydrous silica; hyprolose; lactose monohydrate; microcrystalline cellulose; titanium dioxide; hypromellose; triacetin; iron oxide red - for prevention of vascular ischaemia associated with atherothrombotic events (myocardial infarction, stroke and vascular death) in patients with a history of symptomatic atherosclerotic disease. ,acute coronary syndrome: clopidogrel tablets is indicated in combination with aspirin for patients with: ,- unstable angina or non-st-elevation myocardial infarction in order to prevent early and long-term atherothrombotic events (myocardial infarction, stroke, vascular death or refractory ischaemia). clopidogrel tablets is indicated for the treatment of acute coronary syndrome whether or not patients undergo cardiac revascularization (surgical or pci, with or without stent); ,- st-segment elevation acute myocardial infarction in order to prevent atherothrombotic events. in this population, clopidogrel has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction or stroke in medically treated patients eligible for thrombolytic therapy.

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

pharmacor pty ltd - clopidogrel hydrogen sulfate, quantity: 97.875 mg (equivalent: clopidogrel, qty 75 mg) - tablet, film coated - excipient ingredients: hyprolose; colloidal anhydrous silica; hydrogenated castor oil; titanium dioxide; lactose monohydrate; hypromellose; triacetin; iron oxide red; microcrystalline cellulose - for prevention of vascular ischaemia associated with atherothrombotic events (myocardial infarction, stroke and vascular death) in patients with a history of symptomatic atherosclerotic disease. ,acute coronary syndrome: clopidogrel tablets is indicated in combination with aspirin for patients with: ,- unstable angina or non-st-elevation myocardial infarction in order to prevent early and long-term atherothrombotic events (myocardial infarction, stroke, vascular death or refractory ischaemia). clopidogrel tablets is indicated for the treatment of acute coronary syndrome whether or not patients undergo cardiac revascularization (surgical or pci, with or without stent); ,- st-segment elevation acute myocardial infarction in order to prevent atherothrombotic events. in this population, clopidogrel has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction or stroke in medically treated patients eligible for thrombolytic therapy.