Australië - Engels - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - pravastatin sodium, quantity: 10 mg - tablet, uncoated - excipient ingredients: magnesium stearate; iron oxide yellow; magnesium oxide; croscarmellose sodium; microcrystalline cellulose; povidone; lactose monohydrate - as an adjunct to diet for the treatment of hypercholesterolemia. prior to initiating therapy with pravastatin, secondary causes of hypercholesterolemia (e.g. poorly controlled diabetes mellitus, hypothyrodism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alchoholism) should be identified and treated. apx-pravastatin is indicated in patients with previous myocardial infarction and average (normal) serum cholesterol levels (see clinical trials). indications as at 23 january 2004: as an adjunct to diet for the treatment of hypercholesterolemia. prior to initiating therapy with pravastatin, secondary causes of hypercholesterolemia (e.g. poorly controlled diabetes mellitus, hypothyrodism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alchoholism) should be identified and treated. apx-pravastatin is indicated in patients with previous myocardial infarction including those who have normal (4.0 - 5.5 mmol/l) serum cholesterol levels. apx-pravastatin is indicated in patients with unstable angina pectoris (see clinical trials). apx-pravastatin is indicated as an adjunct to diet and lifestyle modification for the treatment of heterozygous familial hypercholesterolaemia in children and adolescent patients aged 8 years and older (see clinical trails).

Israël - Engels - Ministry of Health

novo nordisk ltd., israel - estradiol as hemihydrate; norethisterone as acetate - film coated tablets - estradiol as hemihydrate 1 mg; norethisterone as acetate 0.5 mg - norethisterone and estrogen - norethisterone and estrogen - hormone replacement therapy (hrt) for oestrogen deficiency symptoms in women more than one year after menopause. prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of , or contraindicated for, other medicinal products approved for the prevention of osteoporosis. the experience treating women older than 65 years is limited.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

novo nordisk pharmaceuticals pty ltd - estradiol hemihydrate, quantity: 2.07 mg (equivalent: estradiol, qty 2 mg); norethisterone acetate, quantity: 1 mg - tablet, film coated - excipient ingredients: lactose monohydrate; maize starch; hyprolose; purified talc; magnesium stearate; hypromellose; triacetin - short term symptomatic treatment of postmenopausal oestrogen deficiency (see dosage and administration and clinical trials). for the prevention of postmenopausal bone mineral density loss. when prescribed solely for the prevention of postmenopausal bone mineral density loss, therapy should only be prescribed for women who are at high risk of osteoporosis and future fracture and who are intolerant of, or contraindicated for, non-oestrogen products approved for prevention of osteoporosis. life style modifications and the risk benefit profile of kliogest should be taken into careful consideration and discussed with the patient, to allow the patient to make an informed decision prior to prescribing. see precautions and dosage and administration. kliogest is for use in postmenopausal women with an intact uterus. in perimenopausal women treated with kliogest the incidence of vaginal bleeding is unacceptably high and therefore therapy should not be initiated sooner than one year after the last menstrual period.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

novo nordisk pharmaceuticals pty ltd - estradiol hemihydrate, quantity: 1.03 mg (equivalent: estradiol, qty 1 mg); norethisterone acetate, quantity: 0.5 mg - tablet, film coated - excipient ingredients: maize starch; copovidone; lactose monohydrate; purified talc; hypromellose; triacetin; magnesium stearate - short term treatment of menopausal symptoms related to oestrogen deficiency in women more than one year after menopause (see dosage and administration and clinical trials). for the prevention of postmenopausal bone mineral density loss. when prescribed solely for the prevention of postmenopausal bone mineral density loss, therapy should only be prescribed for women who are at high risk of osteoporosis and future fracture and who are intolerant of, or contraindicated for, non-oestrogen products approved for prevention of osteoporosis. life style modifications and the risk benefit profiles of kliovance should be taken into careful consideration and discussed with the patient, to allow the patient to make an informed decision prior to prescribing. see precautions and dosage and administration.

Australië - Engels - APVMA (Australian Pesticides and Veterinary Medicines Authority)

4 farmers australia pty ltd - atrazine - water dispersible granule - atrazine triazine active 900.0 g/kg - herbicide - broom millet - dryland | broom millet - irrigated | canola - tt only - post sowing, pre emer | canola(tt varieties only) - pre e - amaranth or amaranthus | annual grass weed - suppression | annual ryegrass | annual ryegrass - suppression | barley grass | barley grass - suppression | barnyard or water grass | billygoat weed or blue top | black bindweed | blackberry nightshade | bladder ketmia | broadleaf weeds | broadleaf weeds - see label | broadleaf weeds and grasses | brome grass | brome grass - suppression | budda or butter pea | burr | caltrop or yellow vine | capeweed | charlock | clover | cobbler's pegs | common sida | common thornapple | corn gromwell, ironweed or sheepweed | crowsfoot grass | dock | dwarf marigold | fat hen | feathertop rhodes grass | flannel weed - sida cordifolia | fleabane | fumitory | geranium | giant or black pigweed | giant sensitive plant | ground or annual ground cherry | ivy leaf speedwell | london rocket | loosestrife | lovegrass | medic | mexican or prickly poppy | mintweed | mouse-ear chickweed | mustard | paddy melon | parthenium weed | paterson's curse | pigeon grass | pigweed spp. | plains grass |

Australië - Engels - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - ezetimibe, quantity: 10 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; carmellose sodium; povidone; sodium lauryl sulfate; polysorbate 80; magnesium stearate - adults (greater than or equal to 18 years),primary hypercholesterolaemia,ezetimibe administered alone, or with an hmg-coa reductase inhibitor (statin), is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia.,homozygous familial hypercholesterolaemia (hofh),ezetimibe, administered with a statin, is indicated for patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).,homozygous sitosterolaemia (phytosterolaemia),ezetimibe is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia.,prevention of cardiovascular disease,ezetimibe is indicated for administration in combination with the maximum tolerated dose of a statin with proven cardiovascular benefit in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) in need of additional lowering of ldl-c in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy (see section 5.1 pharmacodynamic properties, clinical trials).,children and adolescents 10-17 years (pubertal status: boys tanner stage ii and above and girls who are at least one year post-menarche),heterozygous familial hypercholesterolaemia (hefh),ezetimibe co-administered with simvastatin (doses up to 40 mg) is indicated as an adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia where use of a combination product is appropriate: ? patients not appropriately controlled with a statin or ezetimibe alone ? patients already treated with a statin and ezetimibe,homozygous familial hypercholesterolaemia (hofh),ezetimibe co-administered with simvastatin (doses up to 40 mg) is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g. ldl apheresis)

Australië - Engels - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - ezetimibe, quantity: 10 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; carmellose sodium; povidone; sodium lauryl sulfate; polysorbate 80; magnesium stearate - adults (greater than or equal to18 years),primary hypercholesterolaemia,ezetimibe administered alone, or with an hmg-coa reductase inhibitor (statin), is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia.,homozygous familial hypercholesterolaemia (hofh),ezetimibe, administered with a statin, is indicated for patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).,homozygous sitosterolaemia (phytosterolaemia),ezetimibe is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia.,prevention of cardiovascular disease,ezetimibe is indicated for administration in combination with the maximum tolerated dose of a statin with proven cardiovascular benefit in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) in need of additional lowering of ldl-c in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy (see section 5.1 pharmacodynamic properties, clinical trials).,children and adolescents 10-17 years (pubertal status: boys tanner stage ii and above and girls who are at least one year post-menarche),heterozygous familial hypercholesterolaemia (hefh),ezetimibe co-administered with simvastatin (doses up to 40 mg) is indicated as an adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia where use of a combination product is appropriate: ? patients not appropriately controlled with a statin or ezetimibe alone ? patients already treated with a statin and ezetimibe,homozygous familial hypercholesterolaemia (hofh),ezetimibe co-administered with simvastatin (doses up to 40 mg) is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g. ldl apheresis)

Australië - Engels - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - tiotropium bromide monohydrate, quantity: 3.1235 microgram/actuation (equivalent: tiotropium, qty 2.5 microgram/actuation) - inhalation, conventional - excipient ingredients: purified water; hydrochloric acid; disodium edetate; benzalkonium chloride - copd: spiriva respimat is indicated for the long term maintenance treatment of bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease (copd). spiriva respimat is indicated for the prevention of copd exacerbations.,asthma: spiriva respimat is indicated as add-on maintenance bronchodilator treatment in patients aged 6 years and older with moderate to severe asthma.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - tiotropium bromide monohydrate, quantity: 3.1235 microgram/actuation (equivalent: tiotropium, qty 2.5 microgram/actuation) - inhalation, conventional - excipient ingredients: purified water; hydrochloric acid; disodium edetate; benzalkonium chloride - copd: spiriva respimat is indicated for the long term maintenance treatment of bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease (copd). spiriva respimat is indicated for the prevention of copd exacerbations.,asthma: spiriva respimat is indicated as add-on maintenance bronchodilator treatment in patients aged 6 years and older with moderate to severe asthma.

Europese Unie - Engels - EMA (European Medicines Agency)

novartis europharm limited - interferon beta-1b - multiple sclerosis - immunostimulants, - extavia is indicated for the treatment of:patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis;patients with relapsing-remitting multiple sclerosis and two or more relapses within the last two years;patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses.