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

servier laboratories (aust) pty ltd - amlodipine besilate, quantity: 13.87 mg; perindopril arginine, quantity: 5 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; lactose monohydrate - apx-perindopril arginine/ amlodipine is indicated as substitution therapy for the treatment of hypertension and/or stable coronary heart disease in patients already controlled with separate doses of perindopril and amlodipine, given concurrently at the same dose level. treatment should not be initiated with this combination.

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

servier laboratories (aust) pty ltd - amlodipine besilate, quantity: 6.935 mg; perindopril arginine, quantity: 5 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; magnesium stearate; colloidal anhydrous silica - apx-perindopril arginine/ amlodipine is indicated as substitution therapy for the treatment of hypertension and/or stable coronary heart disease in patients already controlled with separate doses of perindopril and amlodipine, given concurrently at the same dose level. treatment should not be initiated with this combination.

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

servier laboratories (aust) pty ltd - perindopril erbumine, quantity: 8 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; magnesium stearate; hydrophobic colloidal silica anhydrous; chlorophyllin-copper complex aluminium lake - indosyl mono is indicated for: the treatment of hypertension; indosyl mono is indicated for: the treatment of heart failure. in such patients it is recommended that indosyl mono be given with a diuretic and/or digoxin under close medical supervision. (the safety and efficacy of indosyl mono has not been demonstrated for new york heart association category iv patients) indosyl mono is indicated for: 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.

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

servier laboratories (aust) pty ltd - perindopril erbumine, quantity: 8 mg - tablet, uncoated - excipient ingredients: hydrophobic colloidal silica anhydrous; magnesium stearate; chlorophyllin-copper complex; lactose monohydrate; microcrystalline cellulose - treatment of hypertension. treatment of heart failure. in such patients it is recommended that perindo be given with a diuretic and/or digoxin under close medical supervision. (the safety and efficacy of perindo has not been demonstrated for new york heart association category iv patients). 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.

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

servier laboratories (aust) pty ltd - perindopril erbumine, quantity: 8 mg - tablet, uncoated - excipient ingredients: hydrophobic colloidal silica anhydrous; lactose monohydrate; chlorophyllin-copper complex; magnesium stearate; microcrystalline cellulose - the treatment of hypertension; and the treatment of heart failure. in such patients it is recommended that idaprex be given with a diuretic and/or digoxin under close medical supervision. (the safety and efficacy of idaprex 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.

Australia - English - 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.

Australia - English - 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.

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

servier laboratories (aust) pty ltd - ivosidenib, quantity: 250 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; colloidal anhydrous silica; magnesium stearate; sodium lauryl sulfate; titanium dioxide; hypromellose; triacetin; indigo carmine aluminium lake; hypromellose acetate succinate; lactose monohydrate - cholangiocarcinoma,tibsovo is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (idh1) r132 mutation after at least one prior line of systemic therapy.,acute myeloid leukaemia,tibsovo is indicated for the treatment of acute myeloid leukaemia (aml) that carries an idh1 r132 mutation:,? as monotherapy, or in combination with azacitidine, in newly diagnosed patients who are not eligible to receive intensive induction chemotherapy; or,? as monotherapy in patients whose aml is relapsed and/or refractory to prior therapy.

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

servier laboratories (australia) pty ltd - indapamide hemihydrate; perindopril arginine -

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

servier laboratories (aust) pty ltd - agomelatine, quantity: 25 mg - tablet, film coated - excipient ingredients: magnesium stearate; povidone; stearic acid; colloidal anhydrous silica; sodium starch glycollate type a; maize starch; lactose monohydrate; propylene glycol; butan-1-ol; ethanol; isopropyl alcohol; shellac; strong ammonia solution; indigo carmine aluminium lake; titanium dioxide; hypromellose; iron oxide yellow; macrogol 6000; glycerol - treatment in adults of: - of major depression (mdd) including prevention of relapse - generalised anxiety disorder (gad)