Malta - English - Medicines Authority

actavis group ptc ehf revkjavikurvegi 76-78, 220 hafnarfjordur, iceland - eplerenone - film-coated tablet - eplerenone 50 mg - diuretics

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare limited - eplerenone - film coated tablet - 25 milligram - eplerenone - aldosterone antagonists - in addition to standard therapy including beta-blockers, to reduce the risk of cardiovascular (cv) mortality and morbidity in stable patients with left ventricular dysfunction (lvef
40 %) and clinical evidence of heart failure after recent myocardial infarction (mi). in addition to standard optimal therapy, to reduce the risk of cardiovascular mortality and morbidity in adult patients with new york heart association (nyha) class ii (chronic) heart failure and left ventricular systolic dysfunction (lvef
30%)

Ireland - English - HPRA (Health Products Regulatory Authority)

actavis group ptc ehf - eplerenone - film coated tablet - 50 milligram - aldosterone antagonists

Ireland - English - HPRA (Health Products Regulatory Authority)

actavis group ptc ehf - eplerenone - film coated tablet - 25 milligram - aldosterone antagonists

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

novartis pharmaceuticals australia pty ltd - valsartan, quantity: 51.4 mg; sacubitril, quantity: 48.6 mg - tablet, film coated - excipient ingredients: purified talc; colloidal anhydrous silica; crospovidone; titanium dioxide; hypromellose; hyprolose; macrogol 4000; magnesium stearate; iron oxide red; microcrystalline cellulose; iron oxide yellow - entresto is indicated in adult patients for the treatment of chronic heart failure (nyha class ii-iv) with reduced ejection fraction.

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

novartis pharmaceuticals australia pty ltd - valsartan, quantity: 25.7 mg; sacubitril, quantity: 24.3 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; crospovidone; iron oxide red; titanium dioxide; macrogol 4000; hypromellose; hyprolose; magnesium stearate; microcrystalline cellulose; iron oxide black; purified talc - entresto is indicated in adult patients for the treatment of chronic heart failure (nyha class ii-iv) with reduced ejection fraction.

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

novartis pharmaceuticals australia pty ltd - valsartan, quantity: 102.8 mg; sacubitril, quantity: 97.2 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; iron oxide black; magnesium stearate; titanium dioxide; iron oxide red; purified talc; crospovidone; hypromellose; macrogol 4000; hyprolose; microcrystalline cellulose - entresto is indicated in adult patients for the treatment of chronic heart failure (nyha class ii-iv) with reduced ejection fraction.

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

arrotex pharmaceuticals pty ltd - ethinylestradiol, quantity: 20 microgram; drospirenone, quantity: 3 mg - tablet, film coated - excipient ingredients: lactose; magnesium stearate; povidone; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - this medicine is indicated for use as: ? an oral contraceptive. ? treatment of moderate acne vulgaris in women who seek oral contraception. ? treatment of symptoms of premenstrual dysphoric disorder (pmdd) in women who have chosen oral contraceptives as their method of birth control. the efficacy of drospirenone 3 mg /ethinylestradiol 20 ?g for pmdd was not assessed beyond 3 cycles. drospirenone 3 mg /ethinylestradiol 20 ?g has not been evaluated for treatment of pms (premenstrual syndrome), see section 5.1 pharmacodynamic properties - clinical trials.

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

viatris pty ltd - lercanidipine hydrochloride, quantity: 10 mg; enalapril maleate, quantity: 20 mg - tablet, film coated - excipient ingredients: lactose monohydrate; sodium bicarbonate; purified talc; quinoline yellow aluminium lake; sodium starch glycollate type a; iron oxide yellow; magnesium stearate; microcrystalline cellulose; hypromellose; titanium dioxide; povidone; macrogol 6000 - treatment of hypertension. treatment should not be initiated with these fixed dose combinations. (see dosage and administration).

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

viatris pty ltd - enalapril maleate, quantity: 10 mg; lercanidipine hydrochloride, quantity: 10 mg - tablet, film coated - excipient ingredients: titanium dioxide; purified talc; povidone; lactose monohydrate; hypromellose; magnesium stearate; microcrystalline cellulose; sodium starch glycollate type a; sodium bicarbonate; macrogol 6000 - treatment of hypertension. treatment should not be initiated with these fixed dose combinations. (see dosage and administration).