Nya Zeeland - engelska - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - docetaxel 10 mg/ml - concentrate for injection - 80 mg/8ml - active: docetaxel 10 mg/ml excipient: citric acid ethanol macrogol 300 nitrogen polysorbate 80

Nya Zeeland - engelska - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - lapatinib ditosilate monohydrate 405mg equivalent to 250 mg lapatinib free base - tablet - 250 mg - active: lapatinib ditosilate monohydrate 405mg equivalent to 250 mg lapatinib free base excipient: magnesium stearate microcrystalline cellulose opadry yellow ys-1-12524-a povidone sodium starch glycolate - her2-positive (her2+) overexpressing metastatic breast cancer tykerb, in combination with capecitabine, is indicated for the treatment of patients with advanced/metastatic breast cancer whose tumours overexpress her2 (erbb2) and whose tumours have progressed after treatment with an anthracycline and a taxane, and who have progressed on prior trastuzumab therapy in the metastatic setting. tykerb, in combination with paclitaxel, is indicated for the first-line treatment of patients with metastatic breast cancer whose tumours overexpress her2 (erbb2) and for whom trastuzumab is not appropriate. hormone receptor-positive metastatic breast cancer tykerb, in combination with an aromatase inhibitor, is indicated for the treatment of post-menopausal women with hormone receptor-positive metastatic breast cancer whose tumours overexpress her2 (erbb2) and for whom hormonal therapy is indicated.

Nya Zeeland - engelska - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - ursodeoxycholic acid 150mg;   - capsule - 150 mg - active: ursodeoxycholic acid 150mg   excipient: colloidal silicon dioxide gelatin magnesium stearate starch

Nya Zeeland - engelska - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - ursodeoxycholic acid 300mg;  ;   - capsule - 300 mg - active: ursodeoxycholic acid 300mg     excipient: colloidal silicon dioxide gelatin magnesium stearate opacode black s-1-17822 opacode black s-1-17823 starch - chronic intrahepatic cholestatic diseases including primary biliary cirrhosis and primary sclerosing cholangitis. in primary biliary cirrhosis actigall improves liver enzymes and igm and prevents worsening of liver histology in patients with less advanced forms of the disease, ie, serum bilirubin less than 2 mg/dl and histologic changes in liver confined to the portal regions. prevention of complications of chronic liver disease has not been established.

Nya Zeeland - engelska - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - cisplatin 1 mg/ml - solution for injection - 1 mg/ml - active: cisplatin 1 mg/ml excipient: hydrochloric acid sodium chloride water for injection - cisplatin ebewe is indicated as palliative therapy to be employed as follows: metastatic non-seminomatous germ cell carcinoma: in established combination therapy with other approved chemotherapeutic agents in patients with metastatic non-seminomatous germ cell tumours who have already received appropriate surgical and/or radiotherapeutic procedures. metastatic ovarian tumours: cisplatin ebewe, as a single agent, is indicated as secondary therapy in patients with metastatic ovarian tumours refractory to standard chemotherapy who have not previously received cisplatin ebewe therapy. advanced and refractory carcinoma of the bladder: cisplatin ebewe, as a single agent, is indicated as secondary therapy in patients with advanced stage bladder cancer refractory to standard chemotherapy who have not previously received cisplatin ebewe therapy. squamous cell carcinoma of the head and neck (refractory to standard chemotherapy): cisplatin ebewe, as a single agent, is indicated as secondary therapy in patients with squamous cell carcinoma of the head and neck refractory to standard chemotherapy who have not previously received cisplatin ebewe therapy.

Nya Zeeland - engelska - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - carbamazepine 20 mg/ml;  ;   - syrup - 100 mg/5ml - active: carbamazepine 20 mg/ml     excipient: caramel hyetellose macrogol stearate 400 methyl hydroxybenzoate powdered cellulose propyl hydroxybenzoate propylene glycol purified water saccharin sodium sorbic acid sorbitol - epilepsy - complex or simple partial seizures (with or without loss of consciousness) with or without secondary generalization. - generalized tonic-clonic seizures. mixed forms of seizures. tegretol® is suitable for both monotherapy and combination therapy. tegretol is usually not effective in absences (petit mal) and myoclonic seizures

Nya Zeeland - engelska - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - carbamazepine 20 mg/ml;   - syrup - 100 mg/5ml - active: carbamazepine 20 mg/ml   excipient: caramel hyetellose macrogol stearate 400 methyl hydroxybenzoate powdered cellulose propyl hydroxybenzoate propylene glycol purified water saccharin sodium sorbic acid sorbitol - epilepsy - complex or simple partial seizures (with or without loss of consciousness) with or without secondary generalization. - generalized tonic-clonic seizures. mixed forms of seizures. tegretol® is suitable for both monotherapy and combination therapy. tegretol is usually not effective in absences (petit mal) and myoclonic seizures

Nya Zeeland - engelska - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - carbamazepine 200mg;  ;   - tablet - 200 mg - active: carbamazepine 200mg     excipient: carmellose sodium colloidal silicon dioxide magnesium stearate microcrystalline cellulose - · epilepsy - complex or simple partial seizures (with or without loss of consciousness) with or without secondary generalization. - generalized tonic-clonic seizures. mixed forms of seizures. tegretol® is suitable for both monotherapy and combination therapy. tegretol is usually not effective in absences (petit mal) and myoclonic seizures

Nya Zeeland - engelska - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - carbamazepine 400mg;   - tablet - 400 mg - active: carbamazepine 400mg   excipient: carmellose sodium colloidal silicon dioxide magnesium stearate microcrystalline cellulose - · epilepsy - complex or simple partial seizures (with or without loss of consciousness) with or without secondary generalization. - generalized tonic-clonic seizures. mixed forms of seizures. tegretol® is suitable for both monotherapy and combination therapy. tegretol is usually not effective in absences (petit mal) and myoclonic seizures

Nya Zeeland - engelska - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - carbamazepine 200mg;  ;   - modified release tablet - 200 mg - active: carbamazepine 200mg     excipient: carmellose sodium colloidal silicon dioxide ethylcellulose hypromellose yellow, red, white suspension iron oxide red iron oxide yellow magnesium stearate methacrylic acid copolymer microcrystalline cellulose polyethylene glycol hydrogenated castor oil purified talc   purified water titanium dioxide - epilepsy - complex or simple partial seizures (with or without loss of consciousness) with or without secondary generalization. - generalized tonic-clonic seizures. mixed forms of seizures. tegretol® is suitable for both monotherapy and combination therapy. tegretol is usually not effective in absences (petit mal) and myoclonic seizures