Ireland - English - HPRA (Health Products Regulatory Authority)

chanelle pharmaceuticals manufacturing limited - pyrantel embonate ; praziquantel - film-coated tablet - 230, 20 mg/tablet - praziquantel, combinations - cats - endoparasiticide

Australia - English - 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.

Australia - English - 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; hydrogenated castor oil; colloidal anhydrous silica; 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.

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

lupin australia pty limited - tadalafil, quantity: 20 mg - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; pregelatinised maize starch; magnesium stearate; croscarmellose sodium; sodium lauryl sulfate; titanium dioxide; hypromellose; purified talc; triacetin; iron oxide yellow - tadalafil gh (tadalafil 20 mg tablets) are indicated for the treatment of: ? erectile dysfunction (ed) in adult males.

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

lupin australia pty limited - tadalafil, quantity: 5 mg - tablet, film coated - excipient ingredients: lactose monohydrate; croscarmellose sodium; sodium lauryl sulfate; magnesium stearate; microcrystalline cellulose; pregelatinised maize starch; titanium dioxide; hypromellose; purified talc; triacetin; iron oxide yellow - tadalafil gh (tadalafil 5 mg tablets) are indicated for the treatment of: ? erectile dysfunction (ed) in adult males; and ? moderate to severe lower urinary tract symptoms (luts) associated with benign prostatic hyperplasia (bph) in adult males.

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

lupin australia pty limited - tadalafil, quantity: 10 mg - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; magnesium stearate; sodium lauryl sulfate; croscarmellose sodium; pregelatinised maize starch; titanium dioxide; hypromellose; purified talc; triacetin; iron oxide yellow - tadalafil gh (tadalafil 10 mg tablets) are indicated for the treatment of: ? erectile dysfunction (ed) in adult males.

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

viiv healthcare pty ltd - cabotegravir, quantity: 30 mg (equivalent: cabotegravir sodium, qty mg) - tablet, film coated - excipient ingredients: titanium dioxide; magnesium stearate; hypromellose; lactose monohydrate; microcrystalline cellulose; sodium starch glycollate type a; macrogol 3350 - vocabria tablets are indicated in combination with rilpivirine tablets for the short-term treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults who are virologically suppressed (hiv-1 rna <50 copies/ml) and have no known or suspected resistance to either cabotegravir or rilpivirine (see sections 4.2 dose and method of administration and 5.1 pharmacodynamic properties, clinical trials) for: ? oral lead in to assess tolerability of cabotegravir prior to administration of cabotegravir prolonged-release suspension for injection plus rilpivirine prolonged-release suspension for injection. ? oral therapy for adults who will miss planned dosing with cabotegravir prolonged-release suspension for injection.

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

takeda pharmaceuticals australia pty ltd - metformin hydrochloride, quantity: 1000 mg; alogliptin benzoate, quantity: 17 mg (equivalent: alogliptin, qty 12.5 mg) - tablet, film coated - excipient ingredients: povidone; microcrystalline cellulose; hypromellose; crospovidone; mannitol; purified talc; titanium dioxide; iron oxide yellow; magnesium stearate - nesina met is indicated to improve glycaemic control in adult patients (> or = 18 years old) with type 2 diabetes mellitus when diet and exercise do not provide adequate glycaemic control and treatment with both alogliptin and metformin is appropriate,,- when treatment with metformin alone does not provide adequate control; or - in combination with a thiazolidinedione or with insulin, when dual therapy does not provide adequate control.,nesina met can also be used to replace separate tablets of alogliptin and metformin in patients already being treated with this combination.

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

takeda pharmaceuticals australia pty ltd - metformin hydrochloride, quantity: 500 mg; alogliptin benzoate, quantity: 17 mg (equivalent: alogliptin, qty 12.5 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; mannitol; titanium dioxide; magnesium stearate; iron oxide yellow; purified talc; crospovidone; povidone; hypromellose - nesina met is indicated to improve glycaemic control in adult patients (> or = 18 years old) with type 2 diabetes mellitus when diet and exercise do not provide adequate glycaemic control and treatment with both alogliptin and metformin is appropriate,,- when treatment with metformin alone does not provide adequate control; or - in combination with a thiazolidinedione or with insulin, when dual therapy does not provide adequate control.,nesina met can also be used to replace separate tablets of alogliptin and metformin in patients already being treated with this combination.

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

takeda pharmaceuticals australia pty ltd - metformin hydrochloride, quantity: 850 mg; alogliptin benzoate, quantity: 17 mg (equivalent: alogliptin, qty 12.5 mg) - tablet, film coated - excipient ingredients: titanium dioxide; purified talc; microcrystalline cellulose; povidone; mannitol; crospovidone; hypromellose; iron oxide yellow; magnesium stearate - nesina met is indicated to improve glycaemic control in adult patients (> or = 18 years old) with type 2 diabetes mellitus when diet and exercise do not provide adequate glycaemic control and treatment with both alogliptin and metformin is appropriate,,- when treatment with metformin alone does not provide adequate control; or - in combination with a thiazolidinedione or with insulin, when dual therapy does not provide adequate control.,nesina met can also be used to replace separate tablets of alogliptin and metformin in patients already being treated with this combination.