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

novartis pharmaceuticals australia pty ltd - ruxolitinib phosphate, quantity: 19.8 mg (equivalent: ruxolitinib, qty 15 mg) - tablet - excipient ingredients: povidone; microcrystalline cellulose; magnesium stearate; lactose monohydrate; sodium starch glycollate type a; colloidal anhydrous silica - jakavi is indicated for the treatment of disease-related splenomegaly or symptoms in patients with primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis.,jakavi is indicated for the treatment of adult patients with polycythemia vera who are resistant to or intolerant of hydroxyurea.,jakavi is indicated for the treatment of patients aged 12 years and older with acute graft-versus-host disease who have inadequate response to corticosteroids.,jakavi is indicated for the treatment of patients aged 12 years and older with chronic graft-versus-host disease who have inadequate response to corticosteroids.

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

novartis pharmaceuticals australia pty ltd - ruxolitinib phosphate, quantity: 6.6 mg (equivalent: ruxolitinib, qty 5 mg) - tablet - excipient ingredients: hyprolose; povidone; lactose monohydrate; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; sodium starch glycollate type a - jakavi is indicated for the treatment of disease-related splenomegaly or symptoms in patients with primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis.,jakavi is indicated for the treatment of adult patients with polycythemia vera who are resistant to or intolerant of hydroxyurea.,jakavi is indicated for the treatment of patients aged 12 years and older with acute graft-versus-host disease who have inadequate response to corticosteroids.,jakavi is indicated for the treatment of patients aged 12 years and older with chronic graft-versus-host disease who have inadequate response to corticosteroids.

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

novartis pharmaceuticals australia pty ltd - ruxolitinib phosphate, quantity: 26.4 mg (equivalent: ruxolitinib, qty 20 mg) - tablet - excipient ingredients: colloidal anhydrous silica; microcrystalline cellulose; hyprolose; magnesium stearate; lactose monohydrate; sodium starch glycollate type a; povidone - jakavi is indicated for the treatment of disease-related splenomegaly or symptoms in patients with primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis.,jakavi is indicated for the treatment of adult patients with polycythemia vera who are resistant to or intolerant of hydroxyurea.,jakavi is indicated for the treatment of patients aged 12 years and older with acute graft-versus-host disease who have inadequate response to corticosteroids.,jakavi is indicated for the treatment of patients aged 12 years and older with chronic graft-versus-host disease who have inadequate response to corticosteroids.

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

besins healthcare australia pty ltd - drospirenone, quantity: 4 mg - tablet, film coated - excipient ingredients: lactose monohydrate; maize starch; povidone; colloidal anhydrous silica; magnesium stearate; hypromellose; triacetin; polysorbate 80; titanium dioxide; indigo carmine aluminium lake; iron oxide yellow - contraception

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

aspen pharma pty ltd - paracetamol, quantity: 500 mg; pseudoephedrine hydrochloride, quantity: 30 mg; chlorphenamine maleate, quantity: 2 mg - tablet, film coated - excipient ingredients: hydrogenated vegetable oil; croscarmellose sodium; pregelatinised maize starch; carnauba wax; magnesium stearate; microcrystalline cellulose; povidone; titanium dioxide; indigo carmine; hyprolose; iron oxide red; iron oxide black - provides fast and effective relief from the symptoms of cold and flu. the non-drowsy day tablet temporarily relieves: blocked noses, runny noses, nagging cough, headaches, body aches and pains, and fever. the night tablet contains an antihistamine and temporarily relieves: blocked noses, headaches, body aches and pains, and fever.

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

organon pharma pty ltd - olmesartan medoxomil, quantity: 40 mg; hydrochlorothiazide, quantity: 25 mg; amlodipine besilate, quantity: 6.944 mg (equivalent: amlodipine, qty mg) - tablet - excipient ingredients: microcrystalline cellulose; pregelatinised maize starch; croscarmellose sodium; magnesium stearate; colloidal anhydrous silica; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - sevikar hct is indicated for the treatment of hypertension, either as replacement for olmesartan medoxomil, amlodipine and hydrochlorothiazide being already taken as separate tablets or as add-on therapy where a patient's blood pressure is not controlled on a dual combination (see dosage and administration). this fixed dose combination is not indicated for initial therapy

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

organon pharma pty ltd - amlodipine besilate, quantity: 6.944 mg (equivalent: amlodipine, qty mg); olmesartan medoxomil, quantity: 40 mg; hydrochlorothiazide, quantity: 12.5 mg - tablet - excipient ingredients: magnesium stearate; croscarmellose sodium; pregelatinised maize starch; microcrystalline cellulose; colloidal anhydrous silica; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - sevikar hct is indicated for the treatment of hypertension, either as replacement for olmesartan medoxomil, amlodipine and hydrochlorothiazide being already taken as separate tablets or as add-on therapy where a patient's blood pressure is not controlled on a dual combination (see dosage and administration). this fixed dose combination is not indicated for initial therapy

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

organon pharma pty ltd - hydrochlorothiazide, quantity: 12.5 mg; amlodipine besilate, quantity: 13.888 mg (equivalent: amlodipine, qty mg); olmesartan medoxomil, quantity: 40 mg - tablet - excipient ingredients: pregelatinised maize starch; microcrystalline cellulose; magnesium stearate; croscarmellose sodium; colloidal anhydrous silica; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - sevikar hct is indicated for the treatment of hypertension, either as replacement for olmesartan medoxomil, amlodipine and hydrochlorothiazide being already taken as separate tablets or as add-on therapy where a patient's blood pressure is not controlled on a dual combination (see dosage and administration). this fixed dose combination is not indicated for initial therapy

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

organon pharma pty ltd - olmesartan medoxomil, quantity: 40 mg; amlodipine besilate, quantity: 13.888 mg/mg (equivalent: amlodipine, qty mg); hydrochlorothiazide, quantity: 25 mg - tablet - excipient ingredients: magnesium stearate; microcrystalline cellulose; croscarmellose sodium; pregelatinised maize starch; colloidal anhydrous silica; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - sevikar hct is indicated for the treatment of hypertension, either as replacement for olmesartan medoxomil, amlodipine and hydrochlorothiazide being already taken as separate tablets or as add-on therapy where a patient's blood pressure is not controlled on a dual combination (see dosage and administration). this fixed dose combination is not indicated for initial therapy

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

organon pharma pty ltd - olmesartan medoxomil, quantity: 20 mg; amlodipine besilate, quantity: 6.944 mg (equivalent: amlodipine, qty mg); hydrochlorothiazide, quantity: 12.5 mg - tablet - excipient ingredients: microcrystalline cellulose; magnesium stearate; pregelatinised maize starch; croscarmellose sodium; colloidal anhydrous silica; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - sevikar hct is indicated for the treatment of hypertension, either as replacement for olmesartan medoxomil, amlodipine and hydrochlorothiazide being already taken as separate tablets or as add-on therapy where a patient's blood pressure is not controlled on a dual combination (see dosage and administration). this fixed dose combination is not indicated for initial therapy