Nova Zelandija - angleščina - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - pertuzumab 420mg equivalent to 30 mg/ml - concentrate for infusion - 420 mg/14ml - active: pertuzumab 420mg equivalent to 30 mg/ml excipient: glacial acetic acid histidine polysorbate 20 sucrose water for injection - metastatic breast cancer perjeta is indicated in combination with trastuzumab and docetaxel for patients with her2-positive metastatic breast cancer who have not received prior anti-her2 therapy or chemotherapy for their metastatic disease.

Nova Zelandija - angleščina - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - erlotinib hydrochloride 109.29mg equivalent to erlotinib 100 mg; erlotinib hydrochloride 109.29mg equivalent to erlotinib 100 mg; erlotinib hydrochloride 109.29mg equivalent to erlotinib 100 mg; erlotinib hydrochloride 109.29mg equivalent to erlotinib 100 mg - film coated tablet - 100 mg - active: erlotinib hydrochloride 109.29mg equivalent to erlotinib 100 mg erlotinib hydrochloride 109.29mg equivalent to erlotinib 100 mg erlotinib hydrochloride 109.29mg equivalent to erlotinib 100 mg excipient: lactose monohydrate magnesium stearate microcrystalline cellulose opacode grey s-1-27645 opadry white y-5-7068 sodium laurilsulfate sodium starch glycolate active: erlotinib hydrochloride 109.29mg equivalent to erlotinib 100 mg excipient: hyprolose hypromellose lactose monohydrate macrogol 400 magnesium stearate microcrystalline cellulose opadry white y-5-7068 sodium laurilsulfate sodium starch glycolate titanium dioxide - · tarceva is indicated for the first-line and maintenance treatment of patients with advanced (stage iiib) or metastatic (stage iv) non-small cell lung cancer (nsclc) with activating egfr mutations. · tarceva is also indicated for the treatment of patients with locally advanced or metastatic non small cell lung cancer (nsclc) who have previously received chemotherapy.

Nova Zelandija - angleščina - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - erlotinib hydrochloride 163.93mg equivalent to erlotinib 150 mg; erlotinib hydrochloride 163.93mg equivalent to erlotinib 150 mg; erlotinib hydrochloride 163.93mg equivalent to erlotinib 150 mg; erlotinib hydrochloride 163.93mg equivalent to erlotinib 150 mg - film coated tablet - 150 mg - active: erlotinib hydrochloride 163.93mg equivalent to erlotinib 150 mg erlotinib hydrochloride 163.93mg equivalent to erlotinib 150 mg erlotinib hydrochloride 163.93mg equivalent to erlotinib 150 mg excipient: lactose monohydrate magnesium stearate microcrystalline cellulose opacode brown s-8-26595 opadry white y-5-7068 sodium laurilsulfate sodium starch glycolate active: erlotinib hydrochloride 163.93mg equivalent to erlotinib 150 mg excipient: hyprolose hypromellose lactose monohydrate macrogol 400 magnesium stearate microcrystalline cellulose opadry white y-5-7068 sodium laurilsulfate sodium starch glycolate titanium dioxide - · tarceva is indicated for the first-line and maintenance treatment of patients with advanced (stage iiib) or metastatic (stage iv) non-small cell lung cancer (nsclc) with activating egfr mutations. · tarceva is also indicated for the treatment of patients with locally advanced or metastatic non small cell lung cancer (nsclc) who have previously received chemotherapy.

Nova Zelandija - angleščina - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - erlotinib hydrochloride 27.32mg equivalent to erlotinib 25 mg.; erlotinib hydrochloride 27.32mg equivalent to erlotinib 25 mg.; erlotinib hydrochloride 27.32mg equivalent to erlotinib 25 mg.; erlotinib hydrochloride 27.32mg equivalent to erlotinib 25 mg. - film coated tablet - 25 mg - active: erlotinib hydrochloride 27.32mg equivalent to erlotinib 25 mg. erlotinib hydrochloride 27.32mg equivalent to erlotinib 25 mg. erlotinib hydrochloride 27.32mg equivalent to erlotinib 25 mg. excipient: lactose monohydrate magnesium stearate microcrystalline cellulose opacode yellow s-1-22970 opadry white y-5-7068 sodium laurilsulfate sodium starch glycolate active: erlotinib hydrochloride 27.32mg equivalent to erlotinib 25 mg. excipient: hyprolose hypromellose lactose monohydrate macrogol 400 magnesium stearate microcrystalline cellulose opadry white y-5-7068 sodium laurilsulfate sodium starch glycolate titanium dioxide - · tarceva is indicated for the first-line and maintenance treatment of patients with advanced (stage iiib) or metastatic (stage iv) non-small cell lung cancer (nsclc) with activating egfr mutations. · tarceva is also indicated for the treatment of patients with locally advanced or metastatic non small cell lung cancer (nsclc) who have previously received chemotherapy.

Nova Zelandija - angleščina - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - vemurafenib 240mg (as a co-precipitate with hypromellose acetate succinate (800 mg total));  ;   - film coated tablet - 240 mg - active: vemurafenib 240mg (as a co-precipitate with hypromellose acetate succinate (800 mg total))     excipient: colloidal silicon dioxide croscarmellose sodium hyprolose iron oxide red macrogol 3350 magnesium stearate polyvinyl alcohol purified talc titanium dioxide - indicated for the treatment of unresectable stage iiic or stage iv metastatic melanoma positive for the braf v600 mutation.

Nova Zelandija - angleščina - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - risdiplam 0.75 mg/ml - powder for oral solution - 750 mcg/ml - active: risdiplam 0.75 mg/ml excipient: ascorbic acid disodium edetate dihydrate isomalt macrogol 600 mannitol sodium benzoate strawberry flavour phs-180152 sucralose tartaric acid - evrysdi is indicated for the treatment of spinal muscular atrophy (sma) in patients aged 2 months and older.

Nova Zelandija - angleščina - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - ribavirin 200mg;  ;   - film coated tablet - 200 mg - active: ribavirin 200mg     excipient: ethylcellulose as aqueous dispersion solids hypromellose as component of opadry 03a14309 pink iron oxide red as component of opadry 03a14309 pink iron oxide yellow as component of opadry 03a14309 pink magnesium stearate maize starch microcrystalline cellulose purified talc as component of opadry 03a14309 pink sodium starch glycolate starch titanium dioxide as component of opadry 03a14309 pink triacetin - copegus is indicated, in combination with peginterferon alfa-2a or interferon alfa-2a, for the treatment of chronic hepatitis c (chc) in adult patients and who are positive for serum hcv rna, including patients with compensated cirrhosis.

Nova Zelandija - angleščina - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - midazolam 1 mg/ml (present as 1.1111mg/ml midazolam hydrochloride);   - solution for injection - 1 mg/ml - active: midazolam 1 mg/ml (present as 1.1111mg/ml midazolam hydrochloride)   excipient: hydrochloric acid sodium chloride sodium hydroxide as 1n solution, for ph adjustment, ph 3.3±0.1 water for injection - hypnovel is indicated for adults · premedication before induction of anaesthesia · conscious sedation before diagnostic or surgical interventions carried out under local anaesthesia · long-term sedation in intensive care units · induction and maintenance of anaesthesia. as an induction agent in inhalation anaesthesia or a sleep-inducing component in combined anaesthesia, including total intravenous anaesthesia. children · premedication before induction of anaesthesia · conscious sedation before diagnosticc or surgical interventions carried out under local anaesthesia · ataralgesia in combination with ketamine · ataralgesia in combination with ketamine in children (i.m. administration).

Nova Zelandija - angleščina - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - midazolam 5 mg/ml (present as midazolam hydrochloride 5.5556mg/ml);   - solution for injection - 5 mg/ml - active: midazolam 5 mg/ml (present as midazolam hydrochloride 5.5556mg/ml)   excipient: hydrochloric acid sodium chloride sodium hydroxide as 1n solution, for ph adjustment, ph 3.3±0.1 water for injection - hypnovel is indicated for adults · premedication before induction of anaesthesia · conscious sedation before diagnostic or surgical interventions carried out under local anaesthesia · long-term sedation in intensive care units · induction and maintenance of anaesthesia. as an induction agent in inhalation anaesthesia or a sleep-inducing component in combined anaesthesia, including total intravenous anaesthesia. children · premedication before induction of anaesthesia · conscious sedation before diagnosticc or surgical interventions carried out under local anaesthesia · ataralgesia in combination with ketamine · ataralgesia in combination with ketamine in children (i.m. administration).

Nova Zelandija - angleščina - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - rituximab 10 mg/ml (murine/human monoclonal antibody);  ;  ;   - concentrate for infusion - 10 mg/ml - active: rituximab 10 mg/ml (murine/human monoclonal antibody)       excipient: citric acid hydrochloric acid polysorbate 80 sodium chloride sodium citrate dihydrate water for injection - mabthera is indicated for the treatment of patients with: · cd20 positive, previously untreated low-grade or follicular, b-cell non-hodgkin's lymphoma in combination with chemotherapy. · cd20 positive, relapsed or chemoresistant low-grade or follicular, b-cell non-hodgkin's lymphoma. · cd20 positive diffuse large b-cell non-hodgkin's lymphoma in combination with chop (cyclophosphamide, doxorubicin, vincristine and prednisone) chemotherapy. mabthera is indicated for maintenance treatment of patients with cd20 positive, low grade or follicular, b-cell non-hodgkin's lymphoma.