New Zealand - English - Medsafe (Medicines Safety Authority)

bristol-myers squibb (nz) limited - ipilimumab 5 mg/ml;   - concentrate for injection - 200 mg/40 ml - active: ipilimumab 5 mg/ml   excipient: hydrochloric acid mannitol nitrogen pentetic acid polysorbate 80 sodium chloride sodium hydroxide trometamol hydrochloride water for injection - yervoy, as monotherapy, is indicated for the treatment of patients with unresectable or metastatic melanoma in adults, 18 years of age or older. yervoy, in combination with opdivo (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic disease melanoma.

New Zealand - English - Medsafe (Medicines Safety Authority)

bristol-myers squibb (nz) limited - ipilimumab 5 mg/ml;   - concentrate for injection - 50 mg/10 ml - active: ipilimumab 5 mg/ml   excipient: hydrochloric acid mannitol nitrogen pentetic acid polysorbate 80 sodium chloride sodium hydroxide trometamol hydrochloride water for injection - yervoy, as monotherapy, is indicated for the treatment of patients with unresectable or metastatic melanoma in adults, 18 years of age or older. yervoy, in combination with opdivo (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic disease melanoma.

Ireland - English - HPRA (Health Products Regulatory Authority)

pfizer limited - fluconazole - solution for infusion - 2 mg/ml - triazole derivatives

Ireland - English - HPRA (Health Products Regulatory Authority)

fresenius kabi limited - cysteine; tryptophan; glutamic acid; tyrosine; histidine; alanine; phenylalanine; leucine; aspartic acid; lysine; arginine; threonine; serine; taurine; valine; proline; methionine; glycine; isoleucine - solution for infusion - 100 millilitre(s) - solutions for parenteral nutrition; amino acids

Malta - English - Medicines Authority

baxter healthcare limited - phenylalanine; histidine; arginine; aspartic acid; olive oil; alanine; threonine; tyrosine; valine; glucose monohydrate; glutamic acid; glycine; methionine; isoleucine; l-tryptophan; lysine; serine; leucine; proline; soybean oil - emulsion for infusion - phenylalanine; histidine; arginine; aspartic acid; olive oil; alanine; threonine; tyrosine; valine; glucose monohydrate; glutamic acid; glycine; methionine; isoleucine; l-tryptophan; lysine; serine; leucine; proline; soybean oil - blood substitutes and perfusion solutions

Malta - English - Medicines Authority

baxter healthcare limited - phenylalanine; histidine; arginine; aspartic acid; olive oil; alanine; threonine; tyrosine; valine; glucose monohydrate; glutamic acid; glycine; methionine; isoleucine; l-tryptophan; lysine; serine; leucine; proline; soybean oil - emulsion for infusion - phenylalanine; histidine; arginine; aspartic acid; olive oil; alanine; threonine; tyrosine; valine; glucose monohydrate 250 g; glutamic acid; glycine; methionine; isoleucine; l-tryptophan; lysine; serine; leucine; proline; soybean oil - blood substitutes and perfusion solutions

Malta - English - Medicines Authority

fresenius kabi limited - phenylalanine; arginine; aspartic acid; alanine; threonine; valine; glutamic acid; glycine; isoleucine; l-lysine; l-methionine; l-tryptophan; l-tyrosine; serine; l-cysteine; leucine; l-histidine; proline - solution for infusion - phenylalanine 7.9 g/l; arginine 11.3 g/l; aspartic acid 3.4 g/l; alanine 16 g/l; threonine 5.6 g/l; valine 7.3 g/l; glutamic acid 5.6 g/l; glycine 7.9 g/l; isoleucine 5.6 g/l; l-lysine 9 g/l; l-methionine 5.6 g/l; l-tryptophan 1.9 g/l; l-tyrosine 230 mg/l; serine 4.5 g/l; l-cysteine 560 mg/g; leucine 7.9 g/l; l-histidine 6.8 g/l; proline 6.8 g/l - blood substitutes and perfusion solutions

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - alirocumab 150 mg/ml;   - solution for injection - 150 mg/ml - active: alirocumab 150 mg/ml   excipient: histidine polysorbate 20 sucrose water for injection - primary hypercholesterolaemia praluent 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - alirocumab 75 mg/ml;   - solution for injection - 75 mg/ml - active: alirocumab 75 mg/ml   excipient: histidine polysorbate 20 sucrose water for injection - primary hypercholesterolaemia praluent 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.

Canada - English - Health Canada

hospira healthcare ulc - l-isoleucine; l-leucine; l-lysine (l-lysine acetate); methionine; l-phenylalanine; l-threonine; tryptophan; l-valine; l-alanine; l-arginine; l-aspartic acid; glutamic acid; glycine; histidine; l-proline; serine; magnesium chloride; sodium phosphate dibasic; n-acetyl-l-tyrosine; dextrose; sodium chloride; potassium chloride - solution - 280mg; 425mg; 446mg; 73mg; 126mg; 170mg; 85mg; 212mg; 422mg; 432mg; 298mg; 314mg; 212mg; 128mg; 307mg; 225mg; 30mg; 49mg; 115mg; 10g; 120mg; 97mg - l-isoleucine 280mg; l-leucine 425mg; l-lysine (l-lysine acetate) 446mg; methionine 73mg; l-phenylalanine 126mg; l-threonine 170mg; tryptophan 85mg; l-valine 212mg; l-alanine 422mg; l-arginine 432mg; l-aspartic acid 298mg; glutamic acid 314mg; glycine 212mg; histidine 128mg; l-proline 307mg; serine 225mg; magnesium chloride 30mg; sodium phosphate dibasic 49mg; n-acetyl-l-tyrosine 115mg; dextrose 10g; sodium chloride 120mg; potassium chloride 97mg - caloric agents