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

servier laboratories (aust) pty ltd - gliclazide, quantity: 80 mg - tablet, film coated - excipient ingredients: pregelatinised maize starch; maize starch; magnesium stearate; lactose monohydrate; purified talc - indications as at 3 november 1999: diabetes mellitus of the maturity onset type, which cannot be controlled by diet alone.

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 (aust) pty ltd - amlodipine besilate, quantity: 13.87 mg; perindopril arginine, quantity: 10 mg - tablet, uncoated - excipient ingredients: colloidal anhydrous silica; microcrystalline cellulose; lactose monohydrate; magnesium stearate - 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 arginine, quantity: 10 mg; amlodipine besilate, quantity: 6.935 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 - 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 australia pty ltd - pegaspargase -