Australien - engelsk - Department of Health (Therapeutic Goods Administration)

servier laboratories (aust) 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; glycerol; hypromellose; iron oxide yellow; iron oxide red; macrogol 6000; titanium dioxide - 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) less than or equal to 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.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

servier laboratories (aust) pty ltd - ivabradine hydrochloride, quantity: 5.39 mg (equivalent: ivabradine, qty 5 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; magnesium stearate; maize starch; maltodextrin; colloidal anhydrous silica; glycerol; hypromellose; iron oxide yellow; iron oxide red; macrogol 6000; titanium dioxide - 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) less than or equal to 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.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

servier laboratories (aust) pty ltd - perindopril arginine, quantity: 10 mg - tablet, film coated - excipient ingredients: macrogol 6000; magnesium stearate; hydrophobic colloidal silica anhydrous; lactose monohydrate; sodium starch glycollate; maltodextrin; colour - coversyl is indicated for: the treatment of hypertension; and the treatment of heart failure. in such patients it is recommended that coversyl be given with a diuretic and/or digoxin under close medical supervision. (the safety and efficacy of coversyl has not been demonstrated for new york heart association category iv patients); and patients with established coronary artery disease (see clinical trials) who are stable on concomitant therapy and have no heart failure, to reduce the risk of non-fatal myocardial infarction or cardiac arrest.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

servier laboratories (aust) pty ltd - perindopril arginine, quantity: 5 mg - tablet, film coated - excipient ingredients: maltodextrin; macrogol 6000; lactose monohydrate; hydrophobic colloidal silica anhydrous; magnesium stearate; sodium starch glycollate; colour - coversyl is indicated for: the treatment of hypertension; and the treatment of heart failure. in such patients it is recommended that coversyl be given with a diuretic and/or digoxin under close medical supervision. (the safety and efficacy of coversyl has not been demonstrated for new york heart association category iv patients); and patients with established coronary artery disease (see clinical trials) who are stable on concomitant therapy and have no heart failure, to reduce the risk of non-fatal myocardial infarction or cardiac arrest.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

servier laboratories (aust) pty ltd - perindopril arginine, quantity: 10 mg - tablet, film coated - excipient ingredients: maltodextrin; magnesium stearate; macrogol 6000; hydrophobic colloidal silica anhydrous; lactose monohydrate; sodium starch glycollate; colour - prexum is indicated for: the treatment of hypertension; and the treatment of heart failure. in such patients it is recommended that prexum be given with a diuretic and/or digoxin under close medical supervision. (the safety and efficacy of prexum has not been demonstrated for new york heart association category iv patients); and patients with established coronary artery disease (see clinical trials) who are stable on concomitant therapy and have no heart failure, to reduce the risk of non-fatal myocardial infarction or cardiac arrest.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

servier laboratories (aust) pty ltd - perindopril arginine, quantity: 5 mg - tablet, film coated - excipient ingredients: maltodextrin; hydrophobic colloidal silica anhydrous; lactose monohydrate; macrogol 6000; sodium starch glycollate; magnesium stearate; colour - prexum is indicated for: the treatment of hypertension; and the treatment of heart failure. in such patients it is recommended that prexum be given with a diuretic and/or digoxin under close medical supervision. (the safety and efficacy of prexum has not been demonstrated for new york heart association category iv patients); and patients with established coronary artery disease (see clinical trials) who are stable on concomitant therapy and have no heart failure, to reduce the risk of non-fatal myocardial infarction or cardiac arrest.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

servier laboratories (aust) pty ltd - pegaspargase, quantity: 750 u/ml - solution, powder for - excipient ingredients: sucrose; dibasic sodium phosphate; monobasic sodium phosphate; sodium chloride; sodium hydroxide; hydrochloric acid - oncaspar is indicated as a component of antineoplastic combination therapy in patients with acute lymphoblastic leukaemia (all).

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

servier laboratories nz ltd - pegaspargase 3750 u (4050u including overage) - powder for injection - 3750 u/5ml - active: pegaspargase 3750 u (4050u including overage) excipient: dibasic sodium phosphate hydrochloric acid monobasic sodium phosphate sodium chloride sodium hydroxide sucrose - oncaspar is indicated as a component of antineoplastic combination therapy in patients with acute lymphoblastic leukaemia (all).

Sydafrika - engelsk - South African Health Products Regulatory Authority (SAHPRA)

servier laboratories south africa (pty) ltd - #n/a - not indicated - none

Sydafrika - engelsk - South African Health Products Regulatory Authority (SAHPRA)

servier laboratories south africa (pty) ltd - #n/a - not indicated - none