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

pharmacor pty ltd - clopidogrel hydrogen sulfate, quantity: 97.875 mg (equivalent: clopidogrel, qty 75 mg) - tablet, film coated - excipient ingredients: hyprolose; hydrogenated castor oil; colloidal anhydrous silica; titanium dioxide; lactose monohydrate; hypromellose; triacetin; iron oxide red; microcrystalline cellulose - for prevention of vascular ischaemia associated with atherothrombotic events (myocardial infarction, stroke and vascular death) in patients with a history of symptomatic atherosclerotic disease. ,acute coronary syndrome: clopidogrel tablets is indicated in combination with aspirin for patients with: ,- unstable angina or non-st-elevation myocardial infarction in order to prevent early and long-term atherothrombotic events (myocardial infarction, stroke, vascular death or refractory ischaemia). clopidogrel tablets is indicated for the treatment of acute coronary syndrome whether or not patients undergo cardiac revascularization (surgical or pci, with or without stent); ,- st-segment elevation acute myocardial infarction in order to prevent atherothrombotic events. in this population, clopidogrel has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction or stroke in medically treated patients eligible for thrombolytic therapy.

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

arrotex pharmaceuticals pty ltd - teriflunomide, quantity: 14 mg - tablet, film coated - excipient ingredients: magnesium stearate; lactose monohydrate; colloidal anhydrous silica; maize starch; microcrystalline cellulose; hyprolose; sodium starch glycollate type a; titanium dioxide; macrogol 8000; hypromellose; purified talc; indigo carmine aluminium lake - teriflunomide tablets are indicated for the treatment of patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical relapses and to delay the progression of physical disability.

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

eisai australia pty ltd - lemborexant, quantity: 10 mg - tablet, film coated - excipient ingredients: hyprolose; magnesium stearate; lactose monohydrate; titanium dioxide; macrogol 8000; hypromellose; purified talc; iron oxide yellow; iron oxide red - dayvigo is indicated for the treatment of insomnia, characterised by difficulties with sleep onset and/or sleep maintenance in accordance with latest diagnostic and statistical manual of mental disorders (dsm) criteria.

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

janssen-cilag pty ltd - ibrutinib, quantity: 560 mg - tablet, film coated - excipient ingredients: lactose monohydrate; croscarmellose sodium; sodium lauryl sulfate; povidone; microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - imbruvica is indicated for the treatment of patients with mcl who have received at least one prior therapy.,imbruvica as a single agent is indicated for the treatment of adult patients with waldenstr?m?s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.,imbruvica in combination with rituximab is indicated for the treatment of adult patients with waldenstrom?s macroglobulinaemia (wm).,imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia/small lymphocytic lymphoma (cll/sll).,imbruvica as a single agent or in combination with bendamustine and rituximab (br) is indicated for the treatment of adult patients with chronic lymphocytic leukaemia/small lymphocytic lymphoma (cll/sll) who have received at least one prior therapy.

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

janssen-cilag pty ltd - ibrutinib, quantity: 420 mg - tablet, film coated - excipient ingredients: lactose monohydrate; croscarmellose sodium; sodium lauryl sulfate; povidone; microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; iron oxide black - imbruvica is indicated for the treatment of patients with mcl who have received at least one prior therapy.,imbruvica as a single agent is indicated for the treatment of adult patients with waldenstr?m?s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.,imbruvica in combination with rituximab is indicated for the treatment of adult patients with waldenstrom?s macroglobulinaemia (wm).,imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia/small lymphocytic lymphoma (cll/sll).,imbruvica as a single agent or in combination with bendamustine and rituximab (br) is indicated for the treatment of adult patients with chronic lymphocytic leukaemia/small lymphocytic lymphoma (cll/sll) who have received at least one prior therapy.

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

janssen-cilag pty ltd - ibrutinib, quantity: 280 mg - tablet, film coated - excipient ingredients: lactose monohydrate; croscarmellose sodium; sodium lauryl sulfate; povidone; microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - imbruvica is indicated for the treatment of patients with mcl who have received at least one prior therapy.,imbruvica as a single agent is indicated for the treatment of adult patients with waldenstr?m?s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.,imbruvica in combination with rituximab is indicated for the treatment of adult patients with waldenstrom?s macroglobulinaemia (wm).,imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia/small lymphocytic lymphoma (cll/sll).,imbruvica as a single agent or in combination with bendamustine and rituximab (br) is indicated for the treatment of adult patients with chronic lymphocytic leukaemia/small lymphocytic lymphoma (cll/sll) who have received at least one prior therapy.

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

janssen-cilag pty ltd - ibrutinib, quantity: 140 mg - tablet, film coated - excipient ingredients: lactose monohydrate; croscarmellose sodium; sodium lauryl sulfate; povidone; microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; iron oxide black - imbruvica is indicated for the treatment of patients with mcl who have received at least one prior therapy.,imbruvica as a single agent is indicated for the treatment of adult patients with waldenstr?m?s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.,imbruvica in combination with rituximab is indicated for the treatment of adult patients with waldenstrom?s macroglobulinaemia (wm).,imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia/small lymphocytic lymphoma (cll/sll).,imbruvica as a single agent or in combination with bendamustine and rituximab (br) is indicated for the treatment of adult patients with chronic lymphocytic leukaemia/small lymphocytic lymphoma (cll/sll) who have received at least one prior therapy.

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

arrotex pharmaceuticals pty ltd - ethinylestradiol, quantity: 20 microgram; drospirenone, quantity: 3 mg - tablet, film coated - excipient ingredients: lactose; magnesium stearate; povidone; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - this medicine is indicated for use as: ? an oral contraceptive. ? treatment of moderate acne vulgaris in women who seek oral contraception. ? treatment of symptoms of premenstrual dysphoric disorder (pmdd) in women who have chosen oral contraceptives as their method of birth control. the efficacy of drospirenone 3 mg /ethinylestradiol 20 ?g for pmdd was not assessed beyond 3 cycles. drospirenone 3 mg /ethinylestradiol 20 ?g has not been evaluated for treatment of pms (premenstrual syndrome), see section 5.1 pharmacodynamic properties - clinical trials.

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

aft pharmaceuticals pty ltd - levonorgestrel, quantity: 100 microgram; ethinylestradiol, quantity: 20 microgram - tablet, film coated - excipient ingredients: gelatin; macrogol 4000; magnesium stearate; maize starch; lactose monohydrate; titanium dioxide; hypromellose - oral contraception

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

dr reddys laboratories australia pty ltd - finasteride, quantity: 5 mg - tablet, film coated - excipient ingredients: lactose monohydrate; pregelatinised maize starch; microcrystalline cellulose; sodium starch glycollate type a; magnesium stearate; docusate sodium; titanium dioxide; hypromellose; indigo carmine aluminium lake; macrogol 400 - treatment of patients with symptomatic benign prostatic hyperplasia (bph) with an enlarged prostate.