New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - telbivudine 600mg;   - film coated tablet - 600 mg - active: telbivudine 600mg   excipient: colloidal silicon dioxide hypromellose macrogol 4000 magnesium stearate microcrystalline cellulose povidone purified talc sodium starch glycolate titanium dioxide - sebivo® is indicated for the treatment of chronic hepatitis b in patients with evidence of viral replication and active liver inflammation. this indication is based on virological, serological, biochemical and histological responses in adult patients with hbeag-positive and hbeag-negative chronic hepatitis b. the following points should be considered when initiating therapy with sebivo: 1. for hbeag-positive patients, sebivo treatment should only be initiated in patients with baseline hbv dna 2 x uln. 2. for hbeag-negative patients, sebivo treatment should only be initiated in patients with baseline hbv dna < 7 log 10 copies/ml

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - telbivudine 20 mg/ml;   - oral solution - 20 mg/ml - active: telbivudine 20 mg/ml   excipient: benzoic acid citric acid passionfruit flavour nitrogen purified water saccharin sodium sodium hydroxide - sebivo® is indicated for the treatment of chronic hepatitis b in patients with evidence of viral replication and active liver inflammation. this indication is based on virological, serological, biochemical and histological responses in adult patients with hbeag-positive and hbeag-negative chronic hepatitis b. the following points should be considered when initiating therapy with sebivo: 1. for hbeag-positive patients, sebivo treatment should only be initiated in patients with baseline hbv dna 2 x uln. 2. for hbeag-negative patients, sebivo treatment should only be initiated in patients with baseline hbv dna < 7 log 10 copies/ml

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - oxaliplatin 100mg;   - powder for injection - 100 mg - active: oxaliplatin 100mg   excipient: lactose

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - oxaliplatin 50mg;   - powder for injection - 50 mg - active: oxaliplatin 50mg   excipient: lactose

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - fingolimod hydrochloride 0.56mg;  ;  ;   - capsule - 0.5 mg - active: fingolimod hydrochloride 0.56mg       excipient: capsugel white 4998 gelatin ink iron oxide yellow magnesium stearate mannitol titanium dioxide - gilenya is indicated as a disease modifying therapy for the treatment of patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - gemcitabine hydrochloride 228mg equivalent to 200 mg gemcitabine;  ;   - powder for injection - 200 mg - active: gemcitabine hydrochloride 228mg equivalent to 200 mg gemcitabine     excipient: mannitol nitrogen sodium acetate as sodium acetate trihydrate sodium hydroxide - non-small cell lung cancer: gemcitabine ebewe, alone or in combination with cisplatin, is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer.

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - tropisetron hydrochloride 5.64mg equivalent to to 5 mg tropisetron - capsule - 5 mg - active: tropisetron hydrochloride 5.64mg equivalent to to 5 mg tropisetron excipient: colloidal silicon dioxide gelatin iron oxide yellow lactose monohydrate magnesium stearate maize starch tekprint red sw-1102 titanium dioxide - the prevention of cancer-chemotherapy-induced nausea and vomiting.

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - tropisetron hydrochloride 1.128 mg/ml equivalent to to 1 mg/ml tropisetron - solution for injection - 1 mg/ml - active: tropisetron hydrochloride 1.128 mg/ml equivalent to to 1 mg/ml tropisetron

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - ciclosporin 100 mg/ml;   - oral solution - 100 mg/ml - active: ciclosporin 100 mg/ml   excipient: corn oil dl-alpha tocopherol ethanol polyethylene glycol hydrogenated castor oil propylene glycol - transplantation indications solid organ transplantation prevention of graft rejection following kidney, liver, heart, combined heart-lung, lung or pancreas allogeneic transplantations. treatment of transplant rejection in patients previously receiving other immunosuppressive agents. bone marrow transplantation prevention of graft rejection following bone marrow transplantation. prevention or treatment of graft-versus-host disease (gvhd).

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - ciclosporin 100mg;   - soft gelatin capsule - 100 mg - active: ciclosporin 100mg   excipient: corn oil dl-alpha tocopherol ethanol gelatin glycerol iron oxide black polyethylene glycol hydrogenated castor oil propylene glycol   titanium dioxide - solid organ transplantation prevention of graft rejection following kidney, liver, heart, combined heart-lung, lung or pancreas allogeneic transplantations. treatment of transplant rejection in patients previously receiving other immunosuppressive agents. bone marrow transplantation prevention of graft rejection following bone marrow transplantation. prevention or treatment of graft-versus-host disease (gvhd).