Ísrael - enska - Ministry of Health

sanofi israel ltd - alirocumab - solution for injection - alirocumab 150 mg / 1 ml - alirocumab - primary hypercholesterolaemia and mixed dyslipidaemiapraluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:- in combination with a statin or statin with other lipid lowering therapies in patients unable to reach ldl-c goals with the maximum tolerated dose of a statin or,- alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.established atherosclerotic cardiovascular diseasepraluent is indicated in adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering ldl-c levels, as an adjunct to correction of other risk factors:- in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or,- alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

Ísrael - enska - Ministry of Health

sanofi israel ltd - alirocumab - solution for injection - alirocumab 75 mg / 1 ml - alirocumab - primary hypercholesterolaemia and mixed dyslipidaemiapraluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:- in combination with a statin or statin with other lipid lowering therapies in patients unable to reach ldl-c goals with the maximum tolerated dose of a statin or,- alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.established atherosclerotic cardiovascular diseasepraluent is indicated in adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering ldl-c levels, as an adjunct to correction of other risk factors:- in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or,- alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

Ástralía - enska - APVMA (Australian Pesticides and Veterinary Medicines Authority)

farmalinx pty ltd - metribuzin - water dispersible granule - metribuzin triazine-triazinones active 750.0 g/kg - herbicide - barley | chickpea | faba bean | green pea (post-emergent) | lentil | lupin | oats | pea (see label for inclusion/exclusions) | p - annual ryegrass | annual ryegrass - suppression | anoda weed | apple-of-peru | awnless barnyard grass | ball mustard | barley grass | barley grass - suppression | barnyard or water grass | bellvine - suppression | blackberry nightshade | brome grass | brome grass - suppression | buchan weed | caltrop or yellow vine | capeweed | cat's ears or flatweeds | charlock | chickweed | cobbler's pegs | common cotula or carrot weed | common heliotrope | common pigweed | common storksbill | common thornapple | corn gromwell, ironweed or sheepweed | corn spurry | creeping speedwell | crownbeard | crowsfoot grass | deadnettle | dock - seedling | dock - suppression | fat hen | field madder | fumitory | giant or black pigweed | great, ripgut or kingston brome | green summer grass | hare's-ear or treacle mustard | heliotrope - heliotropium spp. | horehound | indian hedge mustard | lesser swinecress or bittercress | mountain sorrel | mountain sorrel/purple calandrinia | mouse-ear chickweed | noogoora burr | powell's amaranth |

Ástralía - enska - APVMA (Australian Pesticides and Veterinary Medicines Authority)

axichem pty ltd - metribuzin - water dispersible granule - metribuzin triazine-triazinones active 750.0 g/kg - herbicide - barley | barley - see label for exceptions | chickpea | davis soybean - irrigated | faba bean | lentil | lupin | oats | pea (see - annual ryegrass | anoda weed | apple-of-peru | awnless barnyard grass | ball mustard | barley grass | barnyard or water grass | bellvine - suppression | blackberry nightshade | broadleaf dock - suppression | brome grass | buchan weed | caltrop or yellow vine | capeweed | cat's ears or flatweeds | charlock | chickweed | cobbler's pegs | common cotula or carrot weed | common heliotrope | common pigweed | common storksbill | common thornapple | corn gromwell, ironweed or sheepweed | corn spurry | creeping speedwell | crownbeard | crowsfoot grass | deadnettle | deadnettle - lamium spp. | dock - seedling | fat hen | field madder | fumitory | giant or black pigweed | goathead | great, ripgut or kingston brome | green summer grass | hare's-ear or treacle mustard | heliotrope - heliotropium spp. | horehound | indian hedge mustard | lesser swinecress or bittercress | mountain sorrel/purple calandrinia | mouse-ear chickweed | noogoora burr | pigweed spp. | powell's amaranth | rough poppy | scarlet or red pimpernel | sc

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

chiesi australia pty ltd - obeticholic acid, quantity: 5 mg - tablet - excipient ingredients: magnesium stearate; microcrystalline cellulose; sodium starch glycollate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - ocaliva is indicated for the treatment of primary biliary cholangitis (pbc) in combination with ursodeoxycholic acid (udca) in adults with an inadequate response to udca or as monotherapy in adults unable to tolerate udca.

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

chiesi australia pty ltd - obeticholic acid, quantity: 10 mg - tablet - excipient ingredients: magnesium stearate; microcrystalline cellulose; sodium starch glycollate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - ocaliva is indicated for the treatment of primary biliary cholangitis (pbc) in combination with ursodeoxycholic acid (udca) in adults with an inadequate response to udca or as monotherapy in adults unable to tolerate udca.

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - niraparib tosilate monohydrate, quantity: 159.4 mg (equivalent: niraparib, qty 100 mg) - capsule, hard - excipient ingredients: lactose monohydrate; gelatin; magnesium stearate; titanium dioxide; erythrosine; tartrazine; brilliant blue fcf; propylene glycol; ethanol; isopropyl alcohol; shellac; povidone; tert-butyl alcohol; sodium hydroxide; butan-1-ol; purified water; ethanol absolute; iron oxide black; ammonia; potassium hydroxide - for the maintenance treatment of adult patients with advanced high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.,as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

eisai australia pty ltd - perampanel hemisesquihydrate, quantity: 0.52 mg/ml (equivalent: perampanel, qty 0.5 mg/ml) - oral liquid, suspension - excipient ingredients: poloxamer; sodium benzoate; sorbitol solution (70 per cent) (crystallising); citric acid; polysorbate 65; methylcellulose; benzoic acid; sorbic acid; sulfuric acid; purified water; dimeticone 500; silicon dioxide; peg-40 stearate; microcrystalline cellulose; carmellose sodium - fycompa is indicated for the adjunctive treatment of:,1) partial-onset seizures (pos) with or without secondarily generalised seizures in patients from 4 years of age with epilepsy.,2) primary generalised tonic-clonic seizures (pgtcs) in patients from 7 years of age with idiopathic generalised epilepsy.

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

grifols australia pty ltd - normal immunoglobulin, quantity: 40 g - liquid, multipurpose - excipient ingredients: glycine; water for injections - gamunex normal immunoglobulin (human), 10% is a replacement therapy in: - primary imunodeficiency (pi) diseases. - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulation in: - idiopathic thrombocytopaenic purpura (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count. - guillain barre syndrome (gbs). - chronic inflammatory demyelinating polyneuropathy (cidp),-kawasaki disease.

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 47270 - biventricular pacemaker/defibrillator - a triple chamber rate adaptive icd, with is4 port connecting a quadripolar lv lead, home monitoring functions, max. shock of 40j and df4/is4/is-1 connector. biocompatible titanium housing is hermetically sealed and serves as a potential antipole during shock delivery or in the case of unipolar lead configuration. ellipsoid shape facilitates implanting in the pectoral muscle area. connections for bipolar pacing, sensing, unipolar connections and shock delivery are in the header. mr conditional. rivacor 5 hf-t qp belongs to a family of implantable cardioverter-defibrillators (icds). the primary objective of the therapy is to prevent sudden cardiac death. furthermore, the device is capable of treating bradycardia arrhythmias and cardiac resynchronization therapy with multisite ventricular pacing. the implantation of an icd is a symptomatic therapy with the following objectives: ?termination of spontaneous ventricular fibrillation (vf) through shock delivery ?termination of spontaneous ventricular tachycardia (vt