New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - polatuzumab vedotin 140mg - powder for injection - 140 mg - active: polatuzumab vedotin 140mg excipient: polysorbate 20 sodium hydroxide succinic acid sucrose - polivy in combination with rituximab, cyclophosphamide, doxorubicin and prednisone (r-chp), is indicated for the treatment of adult patients with previously untreated diffuse large b-cell lymphoma. polivy in combination with bendamustine and rituximab is indicated for the treatment of previously treated adult patients with diffuse large b-cell lymphoma who are not candidates for hematopoietic stem cell transplant.

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - enfuvirtide 108mg (includes overage 20%) - injection with diluent - 90 mg/ml - active: enfuvirtide 108mg (includes overage 20%) excipient: hydrochloric acid mannitol sodium carbonate sodium hydroxide water for injection - fuzeon (enfuvirtide) is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in antiretroviral experienced patients with treatment failure due to intolerance to previous antiretroviral agents or with evidence of hiv-1 replication despite ongoing therapy. evidence to support this indication is based on surrogate endpoints (change in viral load and cd4 count) in controlled studies following 48 weeks of treatment (see clinical trials).

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - trastuzumab emtansine 100mg (plus 6% vial overfill = trastuzumab emtansine 106mg) - powder for infusion - 100 mg - active: trastuzumab emtansine 100mg (plus 6% vial overfill = trastuzumab emtansine 106mg) excipient: polysorbate 20 sodium hydroxide succinic acid sucrose - kadcyla as a single agent, is indicated for the treatment of patients with her2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. patients should have either: received prior therapy for metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy. kadcyla, as a single agent, is indicated for the adjuvant treatment of patients with her2-positive early breast cancer who have residual disease after pre-operative systemic treatment that included her2-targeted therapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - trastuzumab emtansine 160mg (plus 7% vial overfill = trastuzumab emtansine 171mg) - powder for infusion - 160 mg - active: trastuzumab emtansine 160mg (plus 7% vial overfill = trastuzumab emtansine 171mg) excipient: polysorbate 20 sodium hydroxide succinic acid sucrose - kadcyla as a single agent, is indicated for the treatment of patients with her2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. patients should have either: received prior therapy for metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy. kadcyla, as a single agent, is indicated for the adjuvant treatment of patients with her2-positive early breast cancer who have residual disease after pre-operative systemic treatment that included her2-targeted therapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - atezolizumab 1200mg;   - concentrate for infusion - 1200 mg/20ml - active: atezolizumab 1200mg   excipient: glacial acetic acid histidine polysorbate 20 sucrose water for injection - tecentriq as monotherapy is indicated as adjuvant treatment following resection and platinum-based chemotherapy for patients with stage ii to iiia* non-small cell lung cancer (nsclc) whose tumours have pd-l1 expression on greater then or equal to 1% of tumour cells (tc). * according to american joint committee on cancer [7th edition] tecentriq, in combination with nab-paclitaxel and carboplatin, is indicated for first-line treatment of patients with metastatic non-squamous nsclc who do not have tumour egfr or alk genomic aberrations. tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) after prior chemotherapy. tecentriq, in combination with paclitaxel and carboplatin, is indicated for the first-line treatment of patients with metastatic non-squamous nsclc who do not have tumour egfr or alk genomic aberrations and whose tumours have pd-l1 expression greater than or equal to 1%. tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer (nsclc). in patients with egfr mutant or alk--positive nsclc, tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies. tecentriq as monotherapy is indicated for the first-line treatment of adults with metastatic nsclc whose tumours have high pd-l1 expression (pd-l1 stained greater than or equal to ?50% of tumour cells [tc greater than or equal to ?50%] or pd-l1 stained tumour-infiltrating immune cells [ic] covering greater than or equal to 10% of the tumour area [ic greater than or equal to ?10%]) as determined by a validated test, and who do not have egfr or alk genomic tumour aberrations.

Australia - English - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - clonazepam -

Australia - English - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - benserazide hydrochloride, quantity: 57 mg (equivalent: benserazide, qty 50 mg); levodopa, quantity: 200 mg - tablet, uncoated - excipient ingredients: iron oxide red; crospovidone; colloidal anhydrous silica; microcrystalline cellulose; magnesium stearate; calcium hydrogen phosphate; mannitol; pregelatinised maize starch; docusate sodium; ethylcellulose - parkinson's disease and parkinsonian symptoms including post-encephalitic and toxic forms, but excluding drug induced parkinsonism.

Australia - English - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - benserazide hydrochloride, quantity: 28.5 mg (equivalent: benserazide, qty 25 mg); levodopa, quantity: 100 mg - capsule, hard - excipient ingredients: mannitol; indigo carmine; iron oxide yellow; hypromellose; titanium dioxide; magnesium stearate; purified talc; gelatin; hydrogenated vegetable oil; povidone; calcium hydrogen phosphate dihydrate; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; shellac; iron oxide red; ethanol absolute; potassium hydroxide; ammonia - parkinson's disease and parkinsonian symptoms including post-encephalitic and toxic forms, but excluding drug induced parkinsonism. madopar hbs is indicated for patients presenting with all types of fluctuations in response (i.e. "peak dose dyskinesia" and "end of dose deterioration") and for better control of nocturnal symptoms.

Australia - English - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - levodopa, quantity: 200 mg; benserazide hydrochloride, quantity: 57 mg (equivalent: benserazide, qty 50 mg) - capsule, hard - excipient ingredients: iron oxide yellow; magnesium stearate; indigo carmine; povidone; gelatin; titanium dioxide; purified talc; microcrystalline cellulose; iron oxide red - parkinson's disease and parkinsonian symptoms including post-encephalitic and toxic forms, but excluding drug induced parkinsonism.

Australia - English - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - atezolizumab, quantity: 1200 mg - injection, concentrated - excipient ingredients: histidine; sucrose; water for injections; polysorbate 20; glacial acetic acid - early-stage non-small cell lung cancer,tecentriq as monotherapy is indicated as adjuvant treatment following complete resection and no progression after platinum-based adjuvant chemotherapy for adult patients with stage ii to iiia (as per 7th edition of the uicc/ajcc staging system) nsclc whose tumours have pd-l1 expression on greater than or equal to 50% of tumour cells.,metastatic non-small cell lung cancer,tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (nsclc). in patients with egfr mutant or alk-positive nsclc, tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies.,tecentriq, in combination with nanoparticle albumin-bound paclitaxel (nab-paclitaxel) and carboplatin, is indicated for first-line treatment of patients with metastatic non-squamous nsclc who do not have tumour egfr or alk genomic aberrations.,tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic nsclc after prior chemotherapy. patients with egfr mutant or alk-positive nsclc should also have received targeted therapies before receiving tecentriq.,small cell lung cancer,tecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of patients with extensive-stage small cell lung cancer (es-sclc).,urothelial carcinoma,tecentriq is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who,? are considered cisplatin ineligible and whose tumours express pd-l1 (pd-l1 stained tumour-infiltrating immune cells [ic] covering greater than or equal to 5% of the tumour area), as determined by a validated test, or,? are considered ineligible for any other platinum-containing chemotherapy regardless of the level of tumour pd-l1 expression.,this indication is approved based on overall response rate and duration of response in a single-arm study. improvements in overall survival, progression-free survival, or health-related quality of life have not been established.,hepatocellular carcinoma,tecentriq, in combination with bevacizumab, is indicated for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (hcc) who have not received prior systemic therapy.