European Union - English - EMA (European Medicines Agency)

zentiva, k.s. - ivabradine hydrochloride - angina pectoris; heart failure - cardiac therapy - symptomatic treatment of chronic stable angina pectoris ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm. ivabradine is indicated:in adults unable to tolerate or with a contra-indication to the use of beta-blockersorin combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose. treatment of chronic heart failure ivabradine is indicated in chronic heart failure nyha ii to iv class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - ivabradine hydrochloride - angina pectoris; heart failure - cardiac therapy - symptomatic treatment of chronic stable angina pectorisivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm.ivabradine is indicated :- in adults unable to tolerate or with a contra-indication to the use of beta-blockers- or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose.treatment of chronic heart failureivabradine is indicated in chronic heart failure nyha ii to iv class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated. (see section 5.1)

Ireland - English - HPRA (Health Products Regulatory Authority)

mcdermott laboratories ltd t/a gerard laboratories - ivabradine oxalate - film coated tablet - 5 milligram - ivabradine

Ireland - English - HPRA (Health Products Regulatory Authority)

mcdermott laboratories ltd t/a gerard laboratories - ivabradine oxalate - film coated tablet - 7.5 milligram - ivabradine

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

arrotex pharmaceuticals pty ltd - ivabradine hydrochloride, quantity: 8.085 mg (equivalent: ivabradine, qty 7.5 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; maltodextrin; maize starch; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; iron oxide yellow; iron oxide red; macrogol 4000 - treatment of chronic stable angina symptomatic treatment of chronic stable angina due to atherosclerotic coronary artery disease in patients with normal sinus rhythm and heart rate at or above 70 bpm, who are unable to tolerate or have a contraindication to the use of beta-blockers, or in combination with atenolol 50mg once daily when angina is inadequately controlled.,treatment of chronic heart failure treatment of symptomatic chronic heart failure of nyha classes ii or iii and with documented left ventricular ejection fraction (lvef) ? 35% in adult patients in sinus rhythm and with heart rate at or above 77 bpm, in combination with optimal standard chronic heart failure treatment.

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

arrotex pharmaceuticals pty ltd - ivabradine hydrochloride, quantity: 8.085 mg (equivalent: ivabradine, qty 7.5 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; magnesium stearate; maize starch; maltodextrin; colloidal anhydrous silica; titanium dioxide; hypromellose; iron oxide yellow; iron oxide red; macrogol 4000 - treatment of chronic stable angina symptomatic treatment of chronic stable angina due to atherosclerotic coronary artery disease in patients with normal sinus rhythm and heart rate at or above 70 bpm, who are unable to tolerate or have a contraindication to the use of beta-blockers.,treatment of chronic heart failure treatment of symptomatic chronic heart failure of nyha classes ii or iii and with documented left ventricular ejection fraction (lvef) ? 35% in adult patients in sinus rhythm and with heart rate at or above 77 bpm, in combination with optimal standard chronic heart failure treatment.

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

arrotex pharmaceuticals pty ltd - ivabradine hydrochloride, quantity: 8.085 mg (equivalent: ivabradine, qty 7.5 mg) - tablet, film coated - excipient ingredients: colloidal anhydrous silica; lactose monohydrate; maltodextrin; magnesium stearate; maize starch; titanium dioxide; hypromellose; iron oxide yellow; iron oxide red; macrogol 4000 - treatment of chronic stable angina symptomatic treatment of chronic stable angina due to atherosclerotic coronary artery disease in patients with normal sinus rhythm and heart rate at or above 70 bpm, who are unable to tolerate or have a contraindication to the use of beta-blockers, or in combination with atenolol 50mg once daily when angina is inadequately controlled.,treatment of chronic heart failure treatment of symptomatic chronic heart failure of nyha classes ii or iii and with documented left ventricular ejection fraction (lvef) ? 35% in adult patients in sinus rhythm and with heart rate at or above 77 bpm, in combination with optimal standard chronic heart failure treatment.

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

arrotex pharmaceuticals pty ltd - ivabradine hydrochloride, quantity: 5.39 mg (equivalent: ivabradine, qty 5 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; maize starch; colloidal anhydrous silica; maltodextrin; magnesium stearate; titanium dioxide; hypromellose; iron oxide yellow; iron oxide red; macrogol 4000 - treatment of chronic stable angina symptomatic treatment of chronic stable angina due to atherosclerotic coronary artery disease in patients with normal sinus rhythm and heart rate at or above 70 bpm, who are unable to tolerate or have a contraindication to the use of beta-blockers, or in combination with atenolol 50mg once daily when angina is inadequately controlled.,treatment of chronic heart failure treatment of symptomatic chronic heart failure of nyha classes ii or iii and with documented left ventricular ejection fraction (lvef) ? 35% in adult patients in sinus rhythm and with heart rate at or above 77 bpm, in combination with optimal standard chronic heart failure treatment.

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

arrotex pharmaceuticals pty ltd - ivabradine hydrochloride, quantity: 5.39 mg (equivalent: ivabradine, qty 5 mg) - tablet, film coated - excipient ingredients: maltodextrin; colloidal anhydrous silica; lactose monohydrate; maize starch; magnesium stearate; titanium dioxide; hypromellose; iron oxide yellow; iron oxide red; macrogol 4000 - treatment of chronic stable angina symptomatic treatment of chronic stable angina due to atherosclerotic coronary artery disease in patients with normal sinus rhythm and heart rate at or above 70 bpm, who are unable to tolerate or have a contraindication to the use of beta-blockers.,treatment of chronic heart failure treatment of symptomatic chronic heart failure of nyha classes ii or iii and with documented left ventricular ejection fraction (lvef) ? 35% in adult patients in sinus rhythm and with heart rate at or above 77 bpm, in combination with optimal standard chronic heart failure treatment.

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

arrotex pharmaceuticals pty ltd - ivabradine hydrochloride, quantity: 5.39 mg (equivalent: ivabradine, qty 5 mg) - tablet, film coated - excipient ingredients: colloidal anhydrous silica; lactose monohydrate; maize starch; magnesium stearate; maltodextrin; titanium dioxide; hypromellose; iron oxide yellow; iron oxide red; macrogol 4000 - treatment of chronic stable angina symptomatic treatment of chronic stable angina due to atherosclerotic coronary artery disease in patients with normal sinus rhythm and heart rate at or above 70 bpm, who are unable to tolerate or have a contraindication to the use of beta-blockers, or in combination with atenolol 50mg once daily when angina is inadequately controlled.,treatment of chronic heart failure treatment of symptomatic chronic heart failure of nyha classes ii or iii and with documented left ventricular ejection fraction (lvef) ? 35% in adult patients in sinus rhythm and with heart rate at or above 77 bpm, in combination with optimal standard chronic heart failure treatment.