New Zealand - engelsk - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - somatropin 12mg (41.4iu [13.8mg] with overage.) - powder for injection - 12 mg - active: somatropin 12mg (41.4iu [13.8mg] with overage.) excipient: dibasic sodium phosphate glycine mannitol monobasic sodium phosphate mannitol metacresol water for injection - adults replacement therapy in adults with pronounced growth hormone deficiency as diagnosed in two different dynamic tests for growth hormone deficiency. patients must also fulfill the following criteria. childhood onset: patients, who were diagnosed as growth hormone deficient during childhood, must be retested and their growth hormone deficiency confirmed before replacement therapy with genotropin miniquick is started. adult onset: patients must have growth hormone deficiency as a result of hypothalamic or pituitary disease and at least one other hormone deficiency diagnosed (except for prolactin) and adequate replacement therapy instituted, before replacement therapy using growth hormone may begin. prader-willi syndrome, for improvement of body composition.

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - somatropin 5.3mg (18.4iu [6.1mg] with overage.) - powder for injection - 5.3 mg - active: somatropin 5.3mg (18.4iu [6.1mg] with overage.) excipient: dibasic sodium phosphate glycine mannitol monobasic sodium phosphate mannitol metacresol water for injection - adults replacement therapy in adults with pronounced growth hormone deficiency as diagnosed in two different dynamic tests for growth hormone deficiency. patients must also fulfill the following criteria. childhood onset: patients, who were diagnosed as growth hormone deficient during childhood, must be retested and their growth hormone deficiency confirmed before replacement therapy with genotropin miniquick is started. adult onset: patients must have growth hormone deficiency as a result of hypothalamic or pituitary disease and at least one other hormone deficiency diagnosed (except for prolactin) and adequate replacement therapy instituted, before replacement therapy using growth hormone may begin. prader-willi syndrome, for improvement of body composition.

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - somatropin 5.8mg equivalent to 5 mg somatropin (after reconstitution) - powder for injection - 5 mg - active: somatropin 5.8mg equivalent to 5 mg somatropin (after reconstitution) excipient: dibasic sodium phosphate glycine mannitol monobasic sodium phosphate mannitol metacresol water for injection - adults replacement therapy in adults with pronounced growth hormone deficiency as diagnosed in two different dynamic tests for growth hormone deficiency. patients must also fulfill the following criteria. childhood onset: patients, who were diagnosed as growth hormone deficient during childhood, must be retested and their growth hormone deficiency confirmed before replacement therapy with genotropin miniquick is started. adult onset: patients must have growth hormone deficiency as a result of hypothalamic or pituitary disease and at least one other hormone deficiency diagnosed (except for prolactin) and adequate replacement therapy instituted, before replacement therapy using growth hormone may begin. prader-willi syndrome, for improvement of body composition.

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - sunitinib malate 16.7mg equivalent to sunitinib 12.5mg;   - capsule - 12.5 mg - active: sunitinib malate 16.7mg equivalent to sunitinib 12.5mg   excipient: croscarmellose sodium gelatin ink iron oxide red magnesium stearate mannitol povidone sodium laurilsulfate titanium dioxide - treatment of advanced renal cell carcinoma

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - sunitinib malate 33.4mg equivalent to sunitinib 25mg;   - capsule - 25 mg - active: sunitinib malate 33.4mg equivalent to sunitinib 25mg   excipient: croscarmellose sodium gelatin ink iron oxide black iron oxide red iron oxide yellow magnesium stearate mannitol povidone sodium laurilsulfate titanium dioxide - treatment of advanced renal cell carcinoma

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - sunitinib malate 50.1mg equivalent to sunitinib 37.5mg;   - capsule - 37.5 mg - active: sunitinib malate 50.1mg equivalent to sunitinib 37.5mg   excipient: croscarmellose sodium gelatin ink iron oxide yellow magnesium stearate mannitol povidone sodium laurilsulfate titanium dioxide - treatment of advanced renal cell carcinoma

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - sunitinib malate 66.8mg equivalent to sunitinib 50mg;   - capsule - 50 mg - active: sunitinib malate 66.8mg equivalent to sunitinib 50mg   excipient: croscarmellose sodium gelatin ink iron oxide black iron oxide red iron oxide yellow magnesium stearate mannitol povidone sodium laurilsulfate titanium dioxide - treatment of advanced renal cell carcinoma

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - filgrastim 0.12mg - solution for injection - 120 mcg/0.2ml - active: filgrastim 0.12mg excipient: glacial acetic acid nitrogen polysorbate 80 sodium hydroxide sorbitol water for injection - established cytotoxic chemotherapy nivestim is indicated for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia and its clinical sequelae in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. the safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. peripheral blood progenitor cell mobilisation (pbpc) nivestim is indicated for the mobilisation of autologous peripheral blood progenitor cells alone, or following myelosuppressive chemotherapy and the mobilisation of peripheral blood progenitor cells in normal donors (allogeneic pbpc). severe chronic neutropenia (scn) long term administration of nivestim is indicated in patients, children or adults, with severe congenital, cyclic or idiopathic neutropenia with an absolute neutrophil count (anc) hiv infection nivestim is indicated for the treatment of persistent neutropenia (anc latest regulatory activityapplication dateapplication typechange(s)statuspayment datepriority6/12/2023changed medicine notificationcontraindications, warnings and precautions - g2; administrative fee (cmn)granted 9/1/202420/12/2023 13/4/2011new higher-risk medicine applicationabridged new higher-risk medicine not containing a new active substancegranted 24/5/201218/4/2011 

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - filgrastim 0.3mg - solution for injection - 300 mcg/0.5ml - active: filgrastim 0.3mg excipient: glacial acetic acid nitrogen polysorbate 80 sodium hydroxide sorbitol water for injection - established cytotoxic chemotherapy nivestim is indicated for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia and its clinical sequelae in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. the safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. peripheral blood progenitor cell mobilisation (pbpc) nivestim is indicated for the mobilisation of autologous peripheral blood progenitor cells alone, or following myelosuppressive chemotherapy and the mobilisation of peripheral blood progenitor cells in normal donors (allogeneic pbpc). severe chronic neutropenia (scn) long term administration of nivestim is indicated in patients, children or adults, with severe congenital, cyclic or idiopathic neutropenia with an absolute neutrophil count (anc) hiv infection nivestim is indicated for the treatment of persistent neutropenia (anc latest regulatory activityapplication dateapplication typechange(s)statuspayment datepriority6/12/2023changed medicine notificationcontraindications, warnings and precautions - g2; administrative fee (cmn)granted 9/1/202420/12/2023 13/4/2011new higher-risk medicine applicationabridged new higher-risk medicine not containing a new active substancegranted 24/5/201218/4/2011 

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - filgrastim 0.48mg - solution for injection - 480 mcg/0.5ml - active: filgrastim 0.48mg excipient: glacial acetic acid nitrogen polysorbate 80 sodium hydroxide sorbitol water for injection - established cytotoxic chemotherapy nivestim is indicated for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia and its clinical sequelae in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. the safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. peripheral blood progenitor cell mobilisation (pbpc) nivestim is indicated for the mobilisation of autologous peripheral blood progenitor cells alone, or following myelosuppressive chemotherapy and the mobilisation of peripheral blood progenitor cells in normal donors (allogeneic pbpc). severe chronic neutropenia (scn) long term administration of nivestim is indicated in patients, children or adults, with severe congenital, cyclic or idiopathic neutropenia with an absolute neutrophil count (anc) hiv infection nivestim is indicated for the treatment of persistent neutropenia (anc latest regulatory activityapplication dateapplication typechange(s)statuspayment datepriority6/12/2023changed medicine notificationcontraindications, warnings and precautions - g2; administrative fee (cmn)granted 9/1/202420/12/2023 13/4/2011new higher-risk medicine applicationabridged new higher-risk medicine not containing a new active substancegranted 24/5/201218/4/2011