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

viatris pty ltd - capecitabine, quantity: 150 mg - tablet, film coated - excipient ingredients: hypromellose; magnesium stearate; iron oxide yellow; microcrystalline cellulose; lactose; purified talc; titanium dioxide; iron oxide red; croscarmellose sodium; purified water - colon cancer:,capecitabine is indicated for the adjuvant treatment of patients with duke?s stage c and highrisk stage b, colon cancer, either as monotherapy or in combination with oxaliplatin.,colorectal cancer:,capecitabine is indicated for the treatment of patients with advanced or metastatic colorectal cancer.,oesophagogastric cancer:,capecitabine is indicated for the first-line treatment of patients with advanced oesophagogastric cancer in combination with a platinum-based regimen.,breast cancer:,capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen unless therapy with these and other standard agents are clinically contraindicated.,capecitabine in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy.

Unione Europea - inglese - EMA (European Medicines Agency)

eli lilly nederland b.v. - ramucirumab - stomach neoplasms - antineoplastic agents - gastric cancercyramza in combination with paclitaxel is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum and fluoropyrimidine chemotherapy.cyramza monotherapy is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum or fluoropyrimidine chemotherapy, for whom treatment in combination with paclitaxel is not appropriate.colorectal cancercyramza, in combination with folfiri (irinotecan, folinic acid, and 5‑fluorouracil), is indicated for the treatment of adult patients with metastatic colorectal cancer (mcrc) with disease progression on or after prior therapy with bevacizumab, oxaliplatin and a fluoropyrimidine.non-small cell lung cancercyramza in combination with docetaxel is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with disease progression after platinum-based chemotherapy.hepatocellular carcinomacyramza monotherapy is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma who have a serum alpha fetoprotein (afp) of ≥ 400 ng/ml and who have been previously treated with sorafenib.

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

cipla australia pty ltd - cyproterone acetate, quantity: 50 mg - tablet, uncoated - excipient ingredients: maize starch; magnesium stearate; povidone; colloidal anhydrous silica; lactose monohydrate; pregelatinised maize starch - women: moderately severe to severe signs of androgenisation. moderately severe/severe forms of hirsutism. moderately severe/severe androgen-dependent loss of scalp hair (moderately severe/severe andogenetic alopecia). moderately severe/severe forms of acne and/or seborrhoea associated with other features of androgenisation. cyproterone acetate inhibits the influence of male sex hormones, which are also produced by the female. it is thus possible to treat diseases in women caused either by increased production of androgens or a particular sensitivity to these hormones. hirsutism and alopecia may be expected to recur over a period of time after cessation of treatment. if cyproterone is taken during pregnancy, the properties of the preparation may lead to signs of feminisation in the male foetus. therefore, in women of child bearing potential, pregnancy must be excluded at the commencement of treatment and ethinyl oestradiol taken as well to ensure contraception. this also promotes regular menstruation. . men: reduction of drive in sexual deviations. cyproterone reduces the force of the sexual urge in men with sexual deviations. whilst under treatment, the man can control himself better in a predisposing stimulatory situation, but there is no influence on any deviating direction of sexual drive. abnormal patterns of sexual behaviour require treatment when they are distressing to the patient. a prerequisite for therapy is the desire by the patient for treatment. cyproterone therapy should be supplemented by psychotherapeutic and sociotherapeutic measures in order to exploit the period of reduced drive for personal and social re-orientation. inoperable prostatic carcinoma. to suppress "flare" with initial lhrh analogue therapy. in long term palliative treatment where lhrh analogues or surgery are ineffective, not tolerated, contraindicated or where oral therapy is preferred. in the treatment of hot flushes in patients treated with lhrh analogues or who have had orchidectomy.

Australia - inglese - 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.

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

medis pharma pty ltd - irinotecan hydrochloride trihydrate, quantity: 40 mg - injection, concentrated - excipient ingredients: (s)-lactic acid; water for injections; sodium hydroxide; sorbitol - for use as a component of first line therapy for patients with metastatic carcinoma of the colon or rectum and in patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.

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

cipla australia pty ltd - irinotecan hydrochloride trihydrate, quantity: 20 mg/ml - injection - excipient ingredients: sodium hydroxide; water for injections; lactic acid; sorbitol - as a component of first line therapy for patients with metastatic carcinoma of the colon or rectum. patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.

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

cipla australia pty ltd - irinotecan hydrochloride trihydrate, quantity: 20 mg/ml - injection - excipient ingredients: sorbitol; lactic acid; water for injections; sodium hydroxide - as a component of first line therapy for patients with metastatic carcinoma of the colon or rectum. patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.

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

sandoz pty ltd - mitozantrone hydrochloride, quantity: 23.284 mg (equivalent: mitozantrone, qty 20 mg) - injection, solution - excipient ingredients: water for injections; sodium acetate; sodium sulfate; nitrogen; dilute hydrochloric acid; glacial acetic acid; sodium chloride - the treatment of metastatic carcinoma of the breast, non-hodgkin's lymphoma, adult acute non-lymphocytic leukaemia (anll) and chronic myelogenous leukaemia in blast crisis.

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

sandoz pty ltd - mitozantrone hydrochloride, quantity: 11.642 mg (equivalent: mitozantrone, qty 10 mg) - injection, solution - excipient ingredients: sodium sulfate; glacial acetic acid; sodium acetate; dilute hydrochloric acid; sodium chloride; nitrogen; water for injections - the treatment of metastatic carcinoma of the breast, non-hodgkin's lymphoma, adult acute non-lymphocytic leukaemia (anll) and chronic myelogenous leukaemia in blast crisis.

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

pfizer australia pty ltd - irinotecan hydrochloride trihydrate, quantity: 100 mg - injection, concentrated - excipient ingredients: sorbitol; sodium hydroxide; water for injections; lactic acid; dilute hydrochloric acid - irinotecan injection is indicated as a component of first-line therapy for patients with metastatic carcinoma of the colon or rectum. irinotecan injection is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.