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

roche products pty ltd - atezolizumab, quantity: 840 mg - injection, concentrated - excipient ingredients: histidine; glacial acetic acid; polysorbate 20; sucrose; water for injections - 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)

australian nuclear science and technology organisation t/a ansto - lutetium (177lu) chloride, quantity: 10 gbq/ml - solution - excipient ingredients: dilute hydrochloric acid; purified water - lutetium (177lu) chloride is a radiopharmaceutical precursor, and it is not intended for direct use in patients. for the treatment of non resectable or metastatic neuroendocrine tumours (nets) expressing somatostatin subtype 2 receptors when coupled with a suitable carrier molecule.

Unione Europea - inglese - EMA (European Medicines Agency)

astrazeneca ab - tremelimumab - carcinoma, hepatocellular - antineoplastic agents - imjudo in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (hcc).imjudo in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (nsclc) with no sensitising egfr mutations or alk positive mutations.

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

bayer australia ltd - cyproterone acetate, quantity: 50 mg - tablet, uncoated - excipient ingredients: magnesium stearate; lactose monohydrate; maize starch; colloidal anhydrous silica; povidone - women: moderately severe to severe signs of androgenization. moderately severe/severe forms of hirsutism.moderately severe/severe androgen-dependent loss of scalp hair (moderately severe/severe androgenic alopecia). moderately severe/severe forms of acne and/or seborrhoea associated with other features of androgenization.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 androcur is taken during pregnancy, the properties of the preparation may lead to signs of feminisation in the male foetus. therefore, in women of childbearing potential, pregnancy must be excluded at the commencement of treatment and ethinyloestradiol taken as well to ensure contraception. this also promotes regular menstruation.men:reduction of drive in sexual deviations androcur 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 pre-requisite for therapy is the desire by the patient for treatment.androcur 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)

alphapharm 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 androgenization -moderately severe/severe forms of hirsutism -moderately severe/severe androgen-dependent loss of scalp hair (moderately severe/severe androgenetic alopecia) -moderately severe/severe forms of acne and/or seborrhoea associated with other features of androgenization,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 cyprone 50 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,cyprone 50 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.,cyprone 50 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)

accord healthcare pty ltd - irinotecan hydrochloride trihydrate, quantity: 100 mg - injection, concentrated - excipient ingredients: hydrochloric acid; lactic acid; sodium hydroxide; water for injections; sorbitol - irinotecan hydrochloride is indicated as a component of first-line therapy for patients with metastatic carcinoma of the colon or rectum. irinotecan hydrochloride is also indicated for 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)

accord healthcare pty ltd - irinotecan hydrochloride trihydrate, quantity: 40 mg - injection, concentrated - excipient ingredients: water for injections; sodium hydroxide; hydrochloric acid; sorbitol; lactic acid - irinotecan hydrochloride is indicated as a component of first-line therapy for patients with metastatic carcinoma of the colon or rectum. irinotecan hydrochloride is also indicated for 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 - capecitabine, quantity: 500 mg - tablet, film coated - excipient ingredients: titanium dioxide; iron oxide red; lactose monohydrate; magnesium stearate; hypromellose; microcrystalline cellulose; purified talc; croscarmellose sodium - colon cancer,capecitabine sandoz is indicated for the adjuvant treatment of patients with dukes' stage c and high-risk stage b, colon cancer, either as monotherapy or in combination with oxaliplatin.,colorectal cancer,capecitabine sandoz is indicated for the treatment of patients with advanced or metastatic colorectal cancer.,oesophagogastric cancer,capecitabine sandoz is indicated for the first-line treatment of patients with advanced oesophagogastric cancer in combination with a platinum-based regimen.,breast cancer,capecitabine sandoz 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 sandoz 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.

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

sandoz pty ltd - capecitabine, quantity: 150 mg - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; hypromellose; croscarmellose sodium; titanium dioxide; purified talc; magnesium stearate; iron oxide red - colon cancer,capecitabine sandoz is indicated for the adjuvant treatment of patients with dukes' stage c and high-risk stage b, colon cancer, either as monotherapy or in combination with oxaliplatin.,colorectal cancer,capecitabine sandoz is indicated for the treatment of patients with advanced or metastatic colorectal cancer.,oesophagogastric cancer,capecitabine sandoz is indicated for the first-line treatment of patients with advanced oesophagogastric cancer in combination with a platinum-based regimen.,breast cancer,capecitabine sandoz 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 sandoz 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.

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

fresenius kabi australia pty ltd - irinotecan hydrochloride trihydrate, quantity: 40 mg - injection, concentrated - excipient ingredients: lactic acid; sorbitol; sodium hydroxide; water for injections - irinotecan injection is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.