Írország - angol - HPRA (Health Products Regulatory Authority)

fresenius kabi deutschland gmbh - soya bean oil, refined ph. eur.; medium chain triglycerides; refined olive oil; fish oil, rich in omega-3 acids; isoleucine; leucine ; methionine; lysine acetate; phenylalanine; threonine; tryptophan; valine; arginine ; histidine; alanine; glycine; proline; serine; tyrosine; taurine; calcium chloride dihydrate; sodium glycerophophate hydrate; magnesium sulphate heptahydrate ; potassium chloride; sodium acetate trihydrate ; zinc sulphate heptahydrate; glucose monohydrate - emulsion for infusion - solutions for parenteral nutrition; combinations

Európai Unió - angol - EMA (European Medicines Agency)

biomarin international limited - pegvaliase - phenylketonurias - other alimentary tract and metabolism products - palynziq is indicated for the treatment of patients with phenylketonuria (pku) aged 16 years and older who have inadequate blood phenylalanine control (blood phenylalanine levels greater than 600 micromol/l) despite prior management with available treatment options.

Egyesült Királyság - angol - MHRA (Medicines & Healthcare Products Regulatory Agency)

b.braun medical ltd - l-phenylalanine; l-threonine; l-tryptophan; l-valine; l-arginine; l-histidine; l-alanine; glycine; l-aspartic acid; l-glutamic acid; l-proline; l-serine; l-tyrosine; acetylcysteine; l-isoleucine; l-leucine; l-lysine monohydrate; l-methionine - solution for infusion - 5.7gram/1litre ; 5.4gram/1litre ; 2.1gram/1litre ; 7.2gram/1litre ; 16.05gram/1litre ; 5.25gram/1litre ; 22.35gram/1litre ; 19.2gram/1litre ; 7.95gram/1litre ; 16.2gram/1litre ; 7.35gram/1litre ; 3gram/1litre ; 500mg/1litre ; 500mg/1litre ; 5.85gram/1litre ; 11.4gram/1litre ; 8.93gram/1litre ; 5.7gram/1litre

Egyesült Királyság - angol - MHRA (Medicines & Healthcare Products Regulatory Agency)

quest vitamins ltd - l-phenylalanine - oral capsule - 500mg

Malajzia - angol - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

cta nutriceuticals (asia) sdn bhd - glutamine; l-phenylalanine -

Új-Zéland - angol - Medsafe (Medicines Safety Authority)

fresenius kabi new zealand limited - alanine 14 g/l;  ;  ; arginine 12 g/l;  ;  ; calcium chloride dihydrate 0.56 g/l (as dihydrate. equivalent to 0.74 g/l calcium chloride dihydrate);  ; glycine 11 g/l;  ;  ;  ; histidine 3 g/l;  ;  ;  ; isoleucine 5 g/l;  ;  ;  ; leucine 7.4 g/l;  ;  ;  ;  ; lysine acetate 9.3 g/l equivalent to l-lysine 6.6 g/l;  ;  ; magnesium sulfate 1.2 g/l (as heptahydrate. equivalent to 2.47 g/l magnesium sulphate heptahydrate);  ;  ; methionine 4.3 g/l;  ;  ; phenylalanine 5.1 g/l;  ;  ; potassium chloride 4.48 g/l;  ; proline 11.2 g/l;  ; serine 6.5 g/l;  ;  ;  ; sodium acetate trihydrate 3.4 g/l (as trihydrate. equivalent to sodium acetate trihydrate 5.62 g/l);  ;  ;  ; sodium glycerophosphate 4.18 g/l (as hydrate. amount added corrected for actual water content of substance);  ; taurine 1 g/l;  ; threonine 4.4 g/l;  ;  ;  ; tryptophan 2 g/l;  ;  ;  ; tyrosine 0.4 g/l;  ; valine 6.2 g/l;  ;  ;  ;  ; zinc sulfate 0.023 g/l (as heptahydrate. equivalent to zinc sulphate 0.0129 g);  ; glucose monohydrate 462 g/l equivalent to glucose (anhydrous) 420 g/l;  ;  ; fish oil 30 g/l; medium-chain triglycerides 60 g/l;  ; olive oil 50 g/l;  ; soya oil 60 g/l;   - emulsion for infusion - active: alanine 14 g/l     arginine 12 g/l     calcium chloride dihydrate 0.56 g/l (as dihydrate. equivalent to 0.74 g/l calcium chloride dihydrate)   glycine 11 g/l       histidine 3 g/l       isoleucine 5 g/l       leucine 7.4 g/l         lysine acetate 9.3 g/l equivalent to l-lysine 6.6 g/l     magnesium sulfate 1.2 g/l (as heptahydrate. equivalent to 2.47 g/l magnesium sulphate heptahydrate)     methionine 4.3 g/l     phenylalanine 5.1 g/l     potassium chloride 4.48 g/l   proline 11.2 g/l   serine 6.5 g/l       sodium acetate trihydrate 3.4 g/l (as trihydrate. equivalent to sodium acetate trihydrate 5.62 g/l)       sodium glycerophosphate 4.18 g/l (as hydrate. amount added corrected for actual water content of substance)   taurine 1 g/l   threonine 4.4 g/l       tryptophan 2 g/l       tyrosine 0.4 g/l   valine 6.2 g/l         zinc sulfate 0.023 g/l (as heptahydrate. equivalent to zinc sulphate 0.0129 g)   excipient: glacial acetic acid nitrogen water for injection active: glucose monohydrate 462 g/l equivalent to glucose (anhydrous) 420 g/l     excipient: hydrochloric acid nitrogen water for injection active: fish oil 30 g/l medium-chain triglycerides 60 g/l   olive oil 50 g/l   soya oil 60 g/l   excipient: dl-alpha tocopherol egg lecithin glycerol nitrogen sodium hydroxide sodium oleate water for injection - parenteral nutrition for adults and children aged 2 years and above when oral or enteral nutrition is impossible, insufficient or contraindicated

Új-Zéland - angol - Medsafe (Medicines Safety Authority)

fresenius kabi new zealand limited - alanine 14 g/l;  ;  ; arginine 12 g/l;  ;  ; glycine 11 g/l;  ;  ;  ; histidine 3 g/l;  ;  ;  ; isoleucine 5 g/l;  ;  ;  ; leucine 7.4 g/l;  ;  ;  ;  ; lysine acetate 9.3 g/l equivalent to l-lysine 6.6 g;  ;  ; methionine 4.3 g/l;  ;  ; phenylalanine 5.1 g/l;  ;  ; proline 11.2 g/l;  ; serine 6.5 g/l;  ;  ;  ; taurine 1 g/l;  ; threonine 4.4 g/l;  ;  ;  ; tryptophan 2 g/l;  ;  ; tyrosine 0.4 g/l;  ; valine 6.2 g/l;  ;  ;  ;  ; glucose monohydrate 462 g/l equivalent to glucose (anhydrous) 420 g/l;  ;  ; fish oil 30 g/l; medium-chain triglycerides 60 g/l;  ; olive oil 50 g/l;  ; soya oil 60 g/l;   - emulsion for infusion - active: alanine 14 g/l     arginine 12 g/l     glycine 11 g/l       histidine 3 g/l       isoleucine 5 g/l       leucine 7.4 g/l         lysine acetate 9.3 g/l equivalent to l-lysine 6.6 g     methionine 4.3 g/l     phenylalanine 5.1 g/l     proline 11.2 g/l   serine 6.5 g/l       taurine 1 g/l   threonine 4.4 g/l       tryptophan 2 g/l     tyrosine 0.4 g/l   valine 6.2 g/l         excipient: glacial acetic acid nitrogen water for injection active: glucose monohydrate 462 g/l equivalent to glucose (anhydrous) 420 g/l     excipient: hydrochloric acid nitrogen water for injection active: fish oil 30 g/l medium-chain triglycerides 60 g/l   olive oil 50 g/l   soya oil 60 g/l   excipient: dl-alpha tocopherol egg lecithin glycerol nitrogen sodium hydroxide sodium oleate water for injection - parenteral nutrition for adults and children aged 2 years and above when oral or enteral nutrition is impossible, insufficient or contraindicated

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - alanine, quantity: 14 g/l; arginine, quantity: 12 g/l; glycine, quantity: 11 g/l; histidine, quantity: 3 g/l; isoleucine, quantity: 5 g/l; leucine, quantity: 7.4 g/l; lysine acetate, quantity: 9.31 g/l (equivalent: lysine, qty 6.6 g/l); methionine, quantity: 4.3 g/l; phenylalanine, quantity: 5.1 g/l; proline, quantity: 11.2 g/l; serine, quantity: 6.5 g/l; taurine, quantity: 1 g/l; threonine, quantity: 4.4 g/l; tryptophan, quantity: 2 g/l; tyrosine, quantity: 400 mg/l; valine, quantity: 6.2 g/l - injection, solution - excipient ingredients: glacial acetic acid; water for injections - to supply amino acids as part of a composite admixture of total parenteral nutrition.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - alanine, quantity: 14 g/l; arginine, quantity: 12 g/l; glycine, quantity: 11 g/l; histidine, quantity: 3 g/l; isoleucine, quantity: 5 g/l; leucine, quantity: 7.4 g/l; lysine acetate, quantity: 9.31 g/l (equivalent: lysine, qty 6.6 g/l); methionine, quantity: 4.3 g/l; phenylalanine, quantity: 5.1 g/l; proline, quantity: 11.2 g/l; serine, quantity: 6.5 g/l; taurine, quantity: 1 g/l; threonine, quantity: 4.4 g/l; tryptophan, quantity: 2 g/l; tyrosine, quantity: 400 mg/l; valine, quantity: 6.2 g/l - injection, solution - excipient ingredients: glacial acetic acid; water for injections - to supply amino acids as part of a composite admixture of total parenteral nutrition.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - alanine,arginine,aspartic acid,calcium chloride dihydrate,glucose monohydrate,glutamic acid,glycine,histidine,isoleucine,leucine,lysine hydrochloride,magnesium sulfate heptahydrate,methionine,phenylalanine,potassium chloride,proline,serine,sodium acetate trihydrate,sodium glycerophosphate,soya oil,threonine,tryptophan,tyrosine,valine -