オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - larotrectinib sulfate, quantity: 24.6 mg/ml - oral liquid, solution - excipient ingredients: sodium citrate; hydroxypropylbetadex; purified water; sucralose; sodium benzoate; citric acid; flavour - vitrakvi (larotrectinib) has provisional approval in australia for the treatment of adult and paediatric patients with locally advanced or metastatic solid tumours that:,? have a neurotrophic tyrosine receptor kinase (ntrk) gene fusion without a known acquired resistance mutation, ? are metastatic or where surgical resection is likely to result in severe morbidity, and ? have either progressed following treatment or who have no satisfactory alternative therapy. the decision to approve this indication has been made on the basis of objective response rate (orr) and duration of response from single arm clinical studies. the sponsor is required to submit further clinical data to confirm the clinical benefit of the medicine.

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - larotrectinib sulfate, quantity: 122.9 mg - capsule, hard - excipient ingredients: titanium dioxide; shellac; gelatin; dimethicone 12500; propylene glycol; brilliant blue fcf aluminium lake; strong ammonia solution - vitrakvi (larotrectinib) has provisional approval in australia for the treatment of adult and paediatric patients with locally advanced or metastatic solid tumours that:,? have a neurotrophic tyrosine receptor kinase (ntrk) gene fusion without a known acquired resistance mutation, ? are metastatic or where surgical resection is likely to result in severe morbidity, and ? have either progressed following treatment or who have no satisfactory alternative therapy. the decision to approve this indication has been made on the basis of objective response rate (orr) and duration of response from single arm clinical studies. the sponsor is required to submit further clinical data to confirm the clinical benefit of the medicine.

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

kissed earth - tyrosine, quantity: 100 mg; melissa officinalis, quantity: 50 mg (equivalent: melissa officinalis, qty 500 mg); calcium pantothenate, quantity: 2.65 mg (equivalent: pantothenic acid, qty 2.43 mg); rehmannia glutinosa, quantity: 25 mg (equivalent: rehmannia glutinosa, qty 250 mg); magnesium glycinate, quantity: 120.57 mg (equivalent: magnesium, qty 17 mg); sodium ascorbate, quantity: 14.06 mg (equivalent: ascorbic acid, qty 12.5 mg); matricaria chamomilla, quantity: 13 mg (equivalent: matricaria chamomilla, qty 130 mg); mecobalamin, quantity: 275 microgram; passiflora incarnata, quantity: 58 mg (equivalent: passiflora incarnata, qty 290 mg); folic acid, quantity: 75 microgram; rhodiola rosea, quantity: 25 mg (equivalent: rhodiola rosea, qty 200 mg); eleutherococcus senticosus, quantity: 56.25 mg (equivalent: eleutherococcus senticosus, qty 1.125 g); levomefolate calcium, quantity: 381 microgram (equivalent: levomefolic acid, qty 334 microgram); choline bitartrate, quantity: 37.5 mg; withania somnifera, quantity: 37.5 mg (equivalent: withania somnifera, qty 750 mg); inositol, quantity: 75 mg; pyridoxal 5-phosphate monohydrate, quantity: 2.5 mg (equivalent: pyridoxine, qty 1.6 mg); ocimum tenuiflorum, quantity: 10 mg (equivalent: hydroxychavicol glucoside (of ocimum tenuiflorum), qty 0.011 mg; equivalent: ocimum tenuiflorum, qty 100 mg) - tablet, film coated - excipient ingredients: magnesium stearate; hypromellose; colloidal anhydrous silica; chlorophyllin-copper complex; microcrystalline cellulose; titanium dioxide; glucose monohydrate; maltodextrin; crospovidone; carnauba wax; calcium hydrogen phosphate dihydrate; maize starch; croscarmellose sodium; macrogol 400; povidone - antioxidant/reduce free radicals formed in the body ; helps reduce/decrease free radical damage to body cells ; maintain/support physical endurance/capacity/stamina ; maintain/support heat/energy production/thermogenesis ; relieve weariness/tiredness/fatigue/feeling of weakness ; maintain/support general health and wellbeing ; maintain/support immune system health ; maintain/support healthy immune system function ; maintain/support muscle health ; aid/assist/helps glucose/sugar/carbohydrate metabolism ; helps decrease/reduce homocysteine levels ; traditionally used in ayurvedic medicine to adaptogen/help body adapt to stress ; aids/assists the body to cope with environmental stress ; support healthy stress response in the body ; traditionally used in western herbal medicine to calms the mind ; traditionally used in western herbal medicine to soothe/calm nerves ; decrease/reduce/relieve symptoms of stress ; decrease/reduce/relieve symptoms of mild anxiety ; traditionally used in western herbal medicine to decrease/reduce/relieve symptoms of mild anxiety ; maintain/support mental endurance/stamina ; maintain/support cognitive function/mental function ; maintain/support nervous system health ; traditionally used in western herbal medicine to calmative/nervous system relaxant ; support healthy emotional/mood balance ; traditionally used in western herbal medicine to decrease/reduce/relieve sleeplessness ; traditionally used in ayurvedic medicine to decrease/reduce/relieve sleeplessness

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - asciminib hydrochloride, quantity: 43.24 mg (equivalent: asciminib, qty 40 mg) - tablet, film coated - excipient ingredients: polyvinyl alcohol; lactose monohydrate; microcrystalline cellulose; colloidal anhydrous silica; croscarmellose sodium; magnesium stearate; iron oxide black; hyprolose; lecithin; titanium dioxide; iron oxide red; xanthan gum; purified talc - scemblix is indicated for the treatment of patients 18 years of age and above with: ? philadelphia chromosome-positive chronic myeloid leukaemia (ph+ cml) in chronic phase (cp) previously treated with two or more tyrosine kinase inhibitors (see section 5.1 clinical trials). ? ph+ cml in cp with the t315i mutation.

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - asciminib hydrochloride, quantity: 21.62 mg (equivalent: asciminib, qty 20 mg) - tablet, film coated - excipient ingredients: colloidal anhydrous silica; magnesium stearate; xanthan gum; titanium dioxide; lactose monohydrate; hyprolose; lecithin; microcrystalline cellulose; iron oxide red; iron oxide yellow; croscarmellose sodium; purified talc; polyvinyl alcohol - scemblix is indicated for the treatment of patients 18 years of age and above with: ? philadelphia chromosome-positive chronic myeloid leukaemia (ph+ cml) in chronic phase (cp) previously treated with two or more tyrosine kinase inhibitors (see section 5.1 clinical trials). ? ph+ cml in cp with the t315i mutation.

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

catalo naturals (australia) pty ltd - tyrosine, quantity: 210.53 mg; plectranthus barbatus, quantity: 108.8 mg (equivalent: plectranthus barbatus, qty 7.072 g); commiphora myrrha, quantity: 120 mg (equivalent: commiphora myrrha, qty 1.2 g); camellia sinensis, quantity: 120 mg (equivalent: camellia sinensis, qty 3 g; equivalent: catechins (of camellia sinensis), qty 72 mg; equivalent: epigallocatechin-3-0-gallate, qty 36 mg; equivalent: caffeine, qty 12 mg); piper nigrum, quantity: 1.34 mg (equivalent: piper nigrum, qty 67 mg); fucus vesiculosus, quantity: 11.52 mg (equivalent: fucus vesiculosus, qty 57.6 mg; equivalent: iodine, qty 13.824 microgram) - capsule, hard - excipient ingredients: magnesium stearate; colloidal anhydrous silica; brilliant blue fcf; titanium dioxide; maltodextrin; allura red ac; hypromellose; microcrystalline cellulose; iron oxide yellow; iron oxide red; erythrosine; gelatin; iron oxide black - helps reduce/decrease free radical damage to body cells ; helps decrease/reduce body weight ; helps in the maintenance of a healthy body weight ; helps maintain/support healthy body mass index (bmi) ; helps enhance/promote/increase body fat loss ; helps enhance/promote/increase weight loss ; helps in the maintenance of healthy blood lipids/blood fats ; helps maintain/support healthy cholesterol ; maintain/support thyroid gland health ; aid/assist thyroid hormone production

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

ezz life science holdings limited - tyrosine, quantity: 1 mg; tagetes erecta, quantity: 24 mg (equivalent: tagetes erecta, qty 1.92 g); betacarotene, quantity: 5 mg; docosahexaenoic acid (dha)-rich oil derived from microalgae schizochytrium sp., quantity: 400 mg (equivalent: docosahexaenoic acid, qty 200 mg); soy phosphatidylserine-enriched soy lecithin liquid, quantity: 100 mg (equivalent: soy phosphatidylserine, qty 20 mg); colecalciferol, quantity: 0.005 mg - capsule, soft - excipient ingredients: purified water; modified food starch; dl-alpha-tocopherol; sunset yellow fcf; gelatin; maize starch; glycerol; soya oil; vegetable oil - antioxidant/reduce free radicals formed in the body ; helps maintain/support healthy eye development ; maintain/support eye health ; helps enhance/promote healthy growth and development ; maintain/support healthy growth and development ; helps enhance/promote general health and wellbeing ; maintain/support general health and wellbeing ; maintain/support immune system health ; enhance/improve/promote/increase cognitive performance ; maintain/support brain function ; maintain/support brain health ; maintain/support brain/central nervous system development

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

integria healthcare australia pty ltd - tyrosine, quantity: 250 mg; zinc amino acid chelate, quantity: 60 mg (equivalent: zinc, qty 12 mg); mecobalamin, quantity: 75 microgram; crocus sativus, quantity: 17.5 mg (equivalent: crocus sativus, qty 53 mg); pyridoxal 5-phosphate monohydrate, quantity: 31.4 mg (equivalent: pyridoxine, qty 20 mg); hypericum perforatum, quantity: 416.7 mg (equivalent: hypericum perforatum, qty 2.5 g; equivalent: hypericins calculated as hypericin (of hypericum perforatum), qty 1.25 mg); levomefolate calcium, quantity: 247.7 microgram (equivalent: levomefolic acid, qty 200 microgram; equivalent: calcium, qty 19.2 microgram) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate dihydrate; purified water; colloidal anhydrous silica; hypromellose; magnesium stearate; croscarmellose sodium; microcrystalline cellulose; maltodextrin; crospovidone; dextrin; macrogol 3350; chlorophyllin-copper complex - maintain/support general health and wellbeing ; maintain/support (state vitamin/mineral/nutrient) levels in the body ; maintain/support (state vitamin/mineral) within normal range ; help maintain/support emotional wellbeing ; traditionally used in western herbal medicine to help maintain/support emotional wellbeing ; traditionally used in western herbal medicine to decrease/reduce/relieve restlessness/excess nervous energy ; traditionally used in western herbal medicine to decrease/reduce/relieve nervous tension/unrest ; traditionally used in western herbal medicine to decrease/reduce/relieve symptoms of mild anxiety ; decrease/reduce/relieve symptoms of mild anxiety ; traditionally used in western herbal medicine to helps reduce occurrence of symptoms of mild anxiety ; helps reduce occurrence of symptoms of mild anxiety ; aid/assist/helps synthesis of neurotransmitters ; traditionally used in western herbal medicine to maintain/support nervous system health ; support healthy emotional/mood balance ; traditionally used in western herbal medicine to support healthy emotional/mood balance

カナダ - 英語 - Health Canada

hospira healthcare ulc - n-acetyl-l-tyrosine; dextrose; l-isoleucine; l-leucine; l-lysine (l-lysine acetate); methionine; l-phenylalanine; l-threonine; serine; glutamic acid; glycine; histidine; l-proline; tryptophan; l-valine; l-alanine; l-arginine; l-aspartic acid - solution - 115mg; 25g; 280mg; 425mg; 446mg; 73mg; 126mg; 170mg; 225mg; 314mg; 212mg; 128mg; 307mg; 85mg; 212mg; 422mg; 432mg; 298mg - n-acetyl-l-tyrosine 115mg; dextrose 25g; l-isoleucine 280mg; l-leucine 425mg; l-lysine (l-lysine acetate) 446mg; methionine 73mg; l-phenylalanine 126mg; l-threonine 170mg; serine 225mg; glutamic acid 314mg; glycine 212mg; histidine 128mg; l-proline 307mg; tryptophan 85mg; l-valine 212mg; l-alanine 422mg; l-arginine 432mg; l-aspartic acid 298mg - caloric agents

カナダ - 英語 - Health Canada

hospira healthcare ulc - tyrosine; lysine (lysine acetate); threonine; l-alanine; proline; glycine; sodium chloride; magnesium chloride; potassium phosphate dibasic; histidine; isoleucine; methionine; tryptophan; arginine; serine; leucine; phenylalanine; valine - solution - 44mg; 624mg; 460mg; 1.1g; 750mg; 1.1g; 410mg; 102mg; 522mg; 260mg; 620mg; 340mg; 150mg; 850mg; 370mg; 810mg; 380mg; 680mg - tyrosine 44mg; lysine (lysine acetate) 624mg; threonine 460mg; l-alanine 1.1g; proline 750mg; glycine 1.1g; sodium chloride 410mg; magnesium chloride 102mg; potassium phosphate dibasic 522mg; histidine 260mg; isoleucine 620mg; methionine 340mg; tryptophan 150mg; arginine 850mg; serine 370mg; leucine 810mg; phenylalanine 380mg; valine 680mg - caloric agents