New Zealand - English - Medsafe (Medicines Safety Authority)

te arai biofarma limited - cinacalcet hydrochloride 33.075mg equivalent to 30 mg cinacalcet - film coated tablet - 30 mg - active: cinacalcet hydrochloride 33.075mg equivalent to 30 mg cinacalcet excipient: colloidal silicon dioxide magnesium stearate microcrystalline cellulose opadry green 85f21867 povidone sodium starch glycolate starch - latest regulatory activity

New Zealand - English - Medsafe (Medicines Safety Authority)

te arai biofarma limited - cinacalcet hydrochloride 66.15mg equivalent to 60 mg cinacalcet - film coated tablet - 60 mg - active: cinacalcet hydrochloride 66.15mg equivalent to 60 mg cinacalcet excipient: colloidal silicon dioxide magnesium stearate microcrystalline cellulose opadry green 85f21867 povidone sodium starch glycolate starch - latest regulatory activity

New Zealand - English - Medsafe (Medicines Safety Authority)

te arai biofarma limited - cinacalcet hydrochloride 99.225mg equivalent to 90 mg cinacalcet - film coated tablet - 90 mg - active: cinacalcet hydrochloride 99.225mg equivalent to 90 mg cinacalcet excipient: colloidal silicon dioxide magnesium stearate microcrystalline cellulose opadry green 85f21867 povidone sodium starch glycolate starch - latest regulatory activity

New Zealand - English - Medsafe (Medicines Safety Authority)

te arai biofarma limited - sapropterin dihydrochloride 100mg equivalent to 76.8 mg sapropterin - soluble tablet - 100 mg - active: sapropterin dihydrochloride 100mg equivalent to 76.8 mg sapropterin excipient: ascorbic acid colloidal silicon dioxide copovidone crospovidone mannitol riboflavin sodium stearyl fumarate - indicated for the treatment of hyperphenylalaninemia (hpa) in sapropterin-responsive adult and paediatric patients with phenylketonuria (pku) or tetrahydrobiopterin (bh4) deficiency.

New Zealand - English - Medsafe (Medicines Safety Authority)

te arai biofarma limited - nitisinone 10mg - capsule - 10 mg - active: nitisinone 10mg excipient: gelatin starch stearic acid titanium dioxide - indicated for the treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (ht-1) in combination with dietary restriction of tyrosine and phenylalanine.

New Zealand - English - Medsafe (Medicines Safety Authority)

te arai biofarma limited - nitisinone 2mg - capsule - 2 mg - active: nitisinone 2mg excipient: gelatin starch stearic acid titanium dioxide - indicated for the treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (ht-1) in combination with dietary restriction of tyrosine and phenylalanine.

New Zealand - English - Medsafe (Medicines Safety Authority)

te arai biofarma limited - nitisinone 5mg - capsule - 5 mg - active: nitisinone 5mg excipient: gelatin starch stearic acid titanium dioxide - indicated for the treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (ht-1) in combination with dietary restriction of tyrosine and phenylalanine.

New Zealand - English - Medsafe (Medicines Safety Authority)

te arai biofarma limited - fosfomycin trometamol 5.631 g equivalent to fosfomycin 3g;   - oral granules - 3 g - active: fosfomycin trometamol 5.631 g equivalent to fosfomycin 3g   excipient: orange flv pdr fa-01142 (20375254) saccharin sodium sucrose tangerine flv pdr fa-00898 (20375218) - treatment of uncomplicated actue cystitis caused by pathogens susceptible to fosfomycin in adult women and adolescents aged over 12.

New Zealand - English - Medsafe (Medicines Safety Authority)

te arai biofarma limited - carglumic acid 200mg - dispersible tablet - 200 mg - active: carglumic acid 200mg excipient: colloidal silicon dioxide croscarmellose sodium microcrystalline cellulose sodium laurilsulfate sodium stearyl fumarate - carglumic acid waymade is indicated in the treatment of: - hyperammonaemia due to n-acetylglutamate synthase primary deficiency. - hyperammonaemia due to isovaleric acidaemia. - hyperammonaemia due to methymalonic acidaemia. - hyperammonaemia due to propionic acidaemia.

New Zealand - English - Medsafe (Medicines Safety Authority)

te arai biofarma limited - nitrofurantoin 25mg (macrocrystals); nitrofurantoin monohydrate 80.7mg - modified release capsule - 100 mg - active: nitrofurantoin 25mg (macrocrystals) nitrofurantoin monohydrate 80.7mg excipient: carbomer 934p gelatin lactose monohydrate magnesium stearate maize starch povidone purified talc sucrose - macrobid is indicated for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of escherichia coli or staphylococcus saprophyticus. therapy with nitrofurantoin may be initiated before results of culture and susceptibility tests are known; therapy should be continued or altered, as appropriate, in accordance with results of the tests. macrobid is indicated for the prophylaxis of urinary tract infections after surgery or procedures involving genitourinary tract. macrobid is not indicated for the treatment of pyelonephritis or peri-nephric abscesses.