Malta - English - Medicines Authority

novartis ireland limited vista building, elm park, merrion road, ballsbridge, dublin 4,, ireland - fluvastatin - prolonged-release tablet - fluvastatin 80 mg - lipid modifying agents

Ireland - English - HPRA (Health Products Regulatory Authority)

novartis ireland limited - fluvastatin - prolonged-release tablet - 80 milligram(s) - hmg coa reductase inhibitors; fluvastatin

Ireland - English - HPRA (Health Products Regulatory Authority)

ethyx pharmaceuticals - fluvastatin - prolonged-release tablet - hmg coa reductase inhibitors; fluvastatin

Ireland - English - HPRA (Health Products Regulatory Authority)

ltt pharma limited - fluvastatin sodium - prolonged-release tablet - 80 milligram(s) - hmg coa reductase inhibitors; fluvastatin

Ireland - English - HPRA (Health Products Regulatory Authority)

imed healthcare ltd. - fluvastatin - prolonged-release tablet - 80 milligram(s) - fluvastatin - coa reductase inhibitors - dyslipidaemia treatment of adults with primary hypercholesterolemia or mixed dyslipidemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate. secondary prevention in coronary heart disease secondary prevention of major adverse cardiac events in adultswith coronary heart disease after percutaneous coronary interventions

Ireland - English - HPRA (Health Products Regulatory Authority)

pco manufacturing ltd. - fluvastatin - prolonged-release tablet - 80 milligram(s) - fluvastatin

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

novartis pharmaceuticals australia pty ltd - fluvastatin sodium, quantity: 84.24 mg (equivalent: fluvastatin, qty 80 mg) - tablet, modified release - excipient ingredients: hypromellose; hyprolose; potassium bicarbonate; magnesium stearate; povidone; microcrystalline cellulose; titanium dioxide; macrogol 8000; iron oxide yellow - hypercholesterolaemia: prior to initiating therapy with fluvastatin for treating hypercholesterolaemia, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. adults: as an adjunct to diet in the treatment of hypercholesterolaemia. heterozygous familial hypercholesterolaemia in paediatric patients: as an adjunct to diet in adolescent boys and in adolescent girls who are at least one year post-menstruation, 10-16 years of age, with heterozygous familial hypercholesterolaemia whose response to dietary restriction has not been adequate and in whom the following findings are present: 1. ldl-c remains greater than or equal to 4.9 mmol/l (190 mg/dl) or 2. ldl-c remains greater than or equal to 4.1 mmol/l (160 mg/dl) and: there is a positive family history of premature cardiovascular disease - or two or more other cardiovascular disease risk

Malta - English - Medicines Authority

novartis pharmaceuticals uk limited - fluvastatin 80 mg - prolonged-release tablet

Malta - English - Medicines Authority

neofarma pharmaceuticals limited 42-46, mill street, qormi, qrm 3105, malta - fluvastatin sodium - prolonged-release tablet - fluvastatin sodium 80 mg - lipid modifying agents

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

novartis pharmaceuticals uk ltd - fluvastatin sodium - modified-release tablet - 80mg