New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - vildagliptin 50mg;  ;   - tablet - 50 mg - active: vildagliptin 50mg     excipient: lactose magnesium stearate microcrystalline cellulose sodium starch glycolate - galvus is indicated as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes mellitus · as monotherapy · in dual combination with metformin, a sulphonylurea (su), or a thiazolidinedione (tzd) when diet, exercise and a single antidiabetic agent do not result in adequate glycaemic control. · in triple combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control · in combination with insulin (with or without metformin) when diet, exercise, and a stable dose of insulin do not result in adequate glycaemic control.

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - diclofenac sodium 1 mg/ml;  ;   - eye drops, solution - 1 mg/ml - active: diclofenac sodium 1 mg/ml     excipient: benzalkonium chloride disodium edetate dihydrate hydrochloric acid hydroxypropyl gamma-cyclodextrin propylene glycol trometamol tyloxapol water for injection

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - diclofenac sodium 1 mg/ml;   - eye drops, solution - 300 mcg/0.3ml - active: diclofenac sodium 1 mg/ml   excipient: boric acid polyoxyl 35 castor oil trometamol water for injection - voltaren ophtha eye drops are indicated for: · post-operative inflammation in cataract surgery and other surgical interventions. · prevention of cystoid macular oedema after cataract extraction with lens implantation. · post-traumatic inflammation in non-penetrating wounds. · inhibition of miosis in cataract surgery. · relief of pain and photophobia. · non-infected inflammatory conditions of the anterior segment of the eye.

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - phentolamine mesilate 10 mg/ml - solution for injection - 10 mg/ml - active: phentolamine mesilate 10 mg/ml excipient: carbon dioxide glucose sodium metabisulfite water for injection - regitine is indicated for: · therapeutic: management of hypertensive episodes that may occur in patients with phaeochromocytoma, during preoperative preparation and surgical manipulation. · diagnostic: diagnosis of phaeochromocytoma by regitine® blocking test if other more specific tests are not available. · preventive: prevention of dermal necrosis and sloughing after extravasation of noradrenaline

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - imatinib mesilate 119.5mg equivalent to 100 mg imatinib base - capsule - 100 mg - active: imatinib mesilate 119.5mg equivalent to 100 mg imatinib base excipient: colloidal silicon dioxide crospovidone gelatin iron oxide red iron oxide yellow magnesium stearate microcrystalline cellulose tekprint red sw-1102 titanium dioxide - · treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive chronic myeloid leukaemia (ph+cml). · treatment of adult and paediatic patients with ph+cml in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. · treatment of adult patients with new diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+all) integrated with chemotherapy. · treatment of adult patients with relapsed or refractory ph+all as monotherapy. · treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. · treatment of adult patients with systemic mastocytosis (sm) without the d816v c-kit mutation or with c-kit mutational status unknown. · treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). · treatment of adult patients with kit+ (cd117) unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). · adjuvant treatment of adult patients following resection of kit+gist. · treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - imatinib mesilate 59.75mg equivalent to 50 mg imatinib base - capsule - 50 mg - active: imatinib mesilate 59.75mg equivalent to 50 mg imatinib base excipient: colloidal silicon dioxide crospovidone gelatin iron oxide yellow magnesium stearate microcrystalline cellulose titanium dioxide - · treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive chronic myeloid leukaemia (ph+cml). · treatment of adult and paediatic patients with ph+cml in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. · treatment of adult patients with new diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+all) integrated with chemotherapy. · treatment of adult patients with relapsed or refractory ph+all as monotherapy. · treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. · treatment of adult patients with systemic mastocytosis (sm) without the d816v c-kit mutation or with c-kit mutational status unknown. · treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). · treatment of adult patients with kit+ (cd117) unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). · adjuvant treatment of adult patients following resection of kit+gist. · treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - imatinib mesilate 119.5mg equivalent to imatinib base 100 mg;   - film coated tablet - 100 mg - active: imatinib mesilate 119.5mg equivalent to imatinib base 100 mg   excipient: colloidal silicon dioxide crospovidone hypromellose magnesium stearate microcrystalline cellulose opadry red 00f15613 opadry yellow 00f12951 purified water - · treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive chronic myeloid leukaemia (ph+cml). · treatment of adult and paediatic patients with ph+cml in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. · treatment of adult patients with new diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+all) integrated with chemotherapy. · treatment of adult patients with relapsed or refractory ph+all as monotherapy. · treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. · treatment of adult patients with systemic mastocytosis (sm) without the d816v c-kit mutation or with c-kit mutational status unknown. · treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). · treatment of adult patients with kit+ (cd117) unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). · adjuvant treatment of adult patients following resection of kit+gist. · treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - imatinib mesilate 478mg equivalent to imatinib base 400 mg;   - film coated tablet - 400 mg - active: imatinib mesilate 478mg equivalent to imatinib base 400 mg   excipient: colloidal silicon dioxide crospovidone hypromellose magnesium stearate microcrystalline cellulose opadry red 00f15613 opadry yellow 00f12951 purified water - · treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive chronic myeloid leukaemia (ph+cml). · treatment of adult and paediatic patients with ph+cml in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. · treatment of adult patients with new diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+all) integrated with chemotherapy. · treatment of adult patients with relapsed or refractory ph+all as monotherapy. · treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. · treatment of adult patients with systemic mastocytosis (sm) without the d816v c-kit mutation or with c-kit mutational status unknown. · treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). · treatment of adult patients with kit+ (cd117) unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). · adjuvant treatment of adult patients following resection of kit+gist. · treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - secukinumab 150 mg/ml;   - solution for injection - 150 mg/ml - active: secukinumab 150 mg/ml   excipient: histidine hydrochloride monohydrate methionine nitrogen polysorbate 80 trehalose dihydrate water for injection - cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - olopatadine hydrochloride 0.111%{relative} equivalent to 0.1% w/v olopatadine;   - eye drops, solution - 0.1% w/v - active: olopatadine hydrochloride 0.111%{relative} equivalent to 0.1% w/v olopatadine   excipient: benzalkonium chloride dibasic sodium phosphate hydrochloric acid sodium chloride sodium hydroxide