Australie - anglais - Department of Health (Therapeutic Goods Administration)

bristol-myers squibb australia pty ltd - nivolumab, quantity: 250 mg - injection, solution - excipient ingredients: sodium citrate dihydrate; sodium chloride; mannitol; pentetic acid; polysorbate 80; hydrochloric acid; sodium hydroxide; water for injections - melanoma,opdivo, as monotherapy, is indicated for the adjuvant treatment of adults and adolescent patients 12 years and older with completely resected stage iib, iic, iii or iv melanoma.,opdivo, as monotherapy, is indicated for the treatment of patients with unresectable or metastatic melanoma.,opdivo, in combination with ipilimumab, is indicated for the treatment of patients with unresectable or metastatic melanoma. the approval of this indication is based on a pre-specified comparison to ipilimumab monotherapy. all analyses comparing nivolumab monotherapy with the nivolumab/ipilimumab combination are descriptive.,non-small cell lung cancer (nsclc),opdivo, in combination with platinum-doublet chemotherapy, is indicated for the neoadjuvant treatment of patients with resectable non-small cell lung cancer (nsclc).,opdivo, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (nsclc) with no egfr or alk genomic tumour aberrations.,opdivo, as monotherapy, is indicated for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (nsclc) with progression on or after prior chemotherapy.,opdivo, as monotherapy, is indicated for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (nsclc) with progression on or after prior chemotherapy. in patients with tumour egfr or alk genomic aberrations, opdivo should be used after progression on or after targeted therapy.,malignant pleural mesothelioma (mpm),opdivo, in combination with ipilimumab, is indicated for the first-line treatment of patients with unresectable malignant pleural mesothelioma.,renal cell carcinoma (rcc),opdivo, in combination with ipilimumab, is indicated for the treatment of patients with intermediate/poor-risk, previously untreated advanced renal cell carcinoma.,opdivo, in combination with cabozantinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma.,opdivo, as monotherapy, is indicated for the treatment of patients with advanced clear cell renal cell carcinoma after prior anti-angiogenic therapy.,classical hodgkin lymphoma (chl),opdivo, as monotherapy, is indicated for the treatment of patients with relapsed or refractory classical hodgkin lymphoma (chl) after autologous stem cell transplant and treatment with brentuximab vedotin. the approval of this indication is based on objective response rate in a single arm study.,squamous cell carcinoma of the head and neck (scchn),opdivo, as monotherapy, is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in patients progressing on or after platinum based therapy.,urothelial carcinoma (uc),opdivo, as monotherapy, is indicated for the adjuvant treatment of patients with muscle invasive urothelial carcinoma (miuc) who are at high risk of recurrence after undergoing radical resection of miuc.,opdivo, as monotherapy, is indicated for the treatment of patients with locally advanced unresectable or metastatic urothelial carcinoma after prior platinum-containing therapy. the approval of this indication is based on objective response rate and duration of response in a single arm study.,hepatocellular carcinoma (hcc),opdivo, as monotherapy, is indicated for the treatment of patients with hepatocellular carcinoma after prior sorafenib therapy. this indication is approved based on objective response rate and duration of response in a single arm study. an improvement in survival or disease-related symptoms has not been established.,oesophageal squamous cell carcinoma (oscc),opdivo in combination with ipilimumab is indicated for the first-line treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ? 1% as determined by a validated test.,opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ? 1% as determined by a validated test.,opdivo, as monotherapy, is indicated for the treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine and platinum based chemotherapy.,adjuvant oesophageal cancer (oc) or gastro-oesophageal junction cancer (gojc),opdivo, as monotherapy, is indicated for the adjuvant treatment of resected oesophageal or gastro-oesophageal junction cancer in patients who have received neoadjuvant chemoradiotherapy.,gastric cancer (gc), gastro-oesophageal junction cancer (gojc), or oesophageal adenocarcinoma (oac),opdivo, in combination with fluoropyrimidine- and platinum-based combination chemotherapy, is indicated for the first-line treatment of patients with her2 negative advanced or metastatic gastric or gastro-oesophageal junction or oesophageal adenocarcinoma.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

amgen australia pty ltd - darbepoetin alfa -

Australie - anglais - Department of Health (Therapeutic Goods Administration)

emcure pharmaceuticals pty ltd - carmustine, quantity: 100 mg - injection, powder for - excipient ingredients: - indications as at 16 december 1985: carmustine is indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following: 1. malignant glioma. 2. multiple myeloma: in combination with prednisone. 3. hodgkin's disease: as secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy. 4. non-hodgkins lymphomas: as secondary therapy in combination with other approved drugs for patients who relapse while being treated with primary therapy or who fail to respond to primary therapy.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - methotrexate, quantity: 2.5 mg - tablet, uncoated - excipient ingredients: magnesium stearate; maize starch; lactose monohydrate; polysorbate 80; microcrystalline cellulose; pregelatinised maize starch - antineoplastic chemotherapy: treatment of breast cancer, gestational choriocarcinoma, and in patients with chorioadenoma destruens and hydatidiform mole. palliation of acute and subacute lymphocytic leukaemia. greatest effect has been observed in palliation of acute lymphoblastic (stem cell) leukaemias. in combination with corticosteroids, methotrexate may be used for induction of remission. the drug is now most commonly used for the maintenance of induced remissions. methoblastin is also effective in the treatment of the advanced stages (iii and iv, peters staging system) of lymphosarcoma, particularly in children and in advanced cases of mycosis fungoides. psoriasis chemotherapy: (see warnings box and precautions). because of the high risk attending to its use, methoblastin is only indicated in the symptomatic control of severe, recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and/or after dermatolo

Nouvelle-Zélande - anglais - Medsafe (Medicines Safety Authority)

eli lilly and company (nz) limited - pemetrexed disodium 151.7mg (as the heptahydrate, equivalent to pemetrexed free acid 100mg) - powder for infusion - 100 mg - active: pemetrexed disodium 151.7mg (as the heptahydrate, equivalent to pemetrexed free acid 100mg) excipient: hydrochloric acid mannitol sodium hydroxide water for injection - · alimta in combination with cisplatin is indicated for initial treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. · alimta as monotherapy is indicated for treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology after prior platinum-based chemotherapy.

Nouvelle-Zélande - anglais - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - docetaxel 10 mg/ml - concentrate for injection - 20 mg/2ml - active: docetaxel 10 mg/ml excipient: citric acid ethanol macrogol 300 polysorbate 80

Nouvelle-Zélande - anglais - 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

Nouvelle-Zélande - anglais - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - aprepitant 125mg - capsule - 125 mg - active: aprepitant 125mg excipient: gelatin hyprolose microcrystalline cellulose sodium laurilsulfate sucrose - emend, in combination with other antiemetic agents, is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of: · moderately emetogenic cancer chemotherapy. · highly emetogenic cancer chemotherapy.

Nouvelle-Zélande - anglais - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - aprepitant 40mg - capsule - 40 mg - active: aprepitant 40mg excipient: hyprolose micronised sodium lauryl sulphate opaque white and mustard yellow hard gelatin capsule (contains titanium dioxide, yellow iron) microcrystalline cellulose purified water sodium laurilsulfate sucrose - emend, in combination with other antiemetic agents, is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of: · moderately emetogenic cancer chemotherapy. · highly emetogenic cancer chemotherapy.

Nouvelle-Zélande - anglais - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - aprepitant 80mg - capsule - 80 mg - active: aprepitant 80mg excipient: gelatin hyprolose microcrystalline cellulose sodium laurilsulfate sucrose - emend, in combination with other antiemetic agents, is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of: · moderately emetogenic cancer chemotherapy. · highly emetogenic cancer chemotherapy.