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

wockhardt bio pty ltd - docetaxel, quantity: 160 mg - injection, concentrated - excipient ingredients: citric acid monohydrate; polysorbate 80; ethanol absolute - docetaxel concentrate for solution for infusion is indicated for;,breast cancer -,metastatic breast cancer : docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer in whom previous chemotherapy has failed. ,docetaxel in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy. ,docetaxel in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress her2 and who previously have not received chemotherapy for metastatic disease. ,adjuvant treatment of breast cancer : docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with node-positive breast cancer. ,doxorubicin and cyclophosphamide followed by docetaxel in combination with trastuzumab (ac-th) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress her2. ,docetaxel in combination with carboplatin and trastuzumab (tch) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress her2. ,docetaxel in combination with cyclophosphamide is indicated for the adjuvant treatment of operable breast cancer with a primary tumour of ? 1cm and < 7cm. ,non small cell lung cancer -,docetaxel is indicated for the treatment of patients with locally advanced or metastatic non small cell lung cancer, including those who have failed platinum-based chemotherapy. ,ovarian cancer - docetaxel is indicated for the treatment of metastatic carcinoma of the ovary after failure of first-line or subsequent chemotherapy. ,prostate cancer -,docetaxel is indicated for the treatment of patients with androgen independent (hormone refractory) prostate cancer. ,head and neck cancer -,docetaxel, in combination with cisplatin and fluorouracil is indicated as induction treatment prior to chemoradiotherapy, for the treatment of patients with locally advanced, squamous cell carcinoma of the head and neck, who have low probability of surgical cure, require organ preservation or where the tumour is technically unresectable.

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

wockhardt bio pty ltd - docetaxel, quantity: 80 mg - injection, concentrated - excipient ingredients: polysorbate 80; ethanol absolute; citric acid monohydrate - docetaxel concentrate for solution for infusion is indicated for;,breast cancer -,metastatic breast cancer : docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer in whom previous chemotherapy has failed. ,docetaxel in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy. ,docetaxel in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress her2 and who previously have not received chemotherapy for metastatic disease. ,adjuvant treatment of breast cancer : docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with node-positive breast cancer. ,doxorubicin and cyclophosphamide followed by docetaxel in combination with trastuzumab (ac-th) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress her2. ,docetaxel in combination with carboplatin and trastuzumab (tch) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress her2. ,docetaxel in combination with cyclophosphamide is indicated for the adjuvant treatment of operable breast cancer with a primary tumour of ? 1cm and < 7cm. ,non small cell lung cancer -,docetaxel is indicated for the treatment of patients with locally advanced or metastatic non small cell lung cancer, including those who have failed platinum-based chemotherapy. ,ovarian cancer - docetaxel is indicated for the treatment of metastatic carcinoma of the ovary after failure of first-line or subsequent chemotherapy. ,prostate cancer -,docetaxel is indicated for the treatment of patients with androgen independent (hormone refractory) prostate cancer. ,head and neck cancer -,docetaxel, in combination with cisplatin and fluorouracil is indicated as induction treatment prior to chemoradiotherapy, for the treatment of patients with locally advanced, squamous cell carcinoma of the head and neck, who have low probability of surgical cure, require organ preservation or where the tumour is technically unresectable.

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

sun pharma anz pty ltd - pemetrexed disodium, quantity: 1102.8 mg (equivalent: pemetrexed, qty 1000 mg) - injection, powder for - excipient ingredients: mannitol; sodium hydroxide; hydrochloric acid - malignant pleural mesothelioma pemetrexed sun, in combination with cisplatin, is indicated for the treatment of patients with malignant pleural mesothelioma.,non-small cell lung cancer pemetrexed sun in combination with cisplatin is indicated for initial treatment of patients with locally advance or metastatic non-small cell lung cancer other than predominantly squamous cell histology. pemetrexed sun as monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology after prior platinum-based chemotherapy.

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

sun pharma anz pty ltd - pemetrexed disodium, quantity: 551.4 mg (equivalent: pemetrexed, qty 500 mg) - injection, powder for - excipient ingredients: mannitol; sodium hydroxide; hydrochloric acid - malignant pleural mesothelioma pemetrexed sun, in combination with cisplatin, is indicated for the treatment of patients with malignant pleural mesothelioma.,non-small cell lung cancer pemetrexed sun in combination with cisplatin is indicated for initial treatment of patients with locally advance or metastatic non-small cell lung cancer other than predominantly squamous cell histology. pemetrexed sun as monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology after prior platinum-based chemotherapy.

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

sun pharma anz pty ltd - pemetrexed disodium, quantity: 110.28 mg (equivalent: pemetrexed, qty 100 mg) - injection, powder for - excipient ingredients: mannitol; sodium hydroxide; hydrochloric acid - malignant pleural mesothelioma pemetrexed sun, in combination with cisplatin, is indicated for the treatment of patients with malignant pleural mesothelioma.,non-small cell lung cancer pemetrexed sun in combination with cisplatin is indicated for initial treatment of patients with locally advance or metastatic non-small cell lung cancer other than predominantly squamous cell histology. pemetrexed sun as monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology after prior platinum-based chemotherapy.

Australia - English - 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.

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

galderma australia pty ltd - methyl aminolevulinate hydrochloride, quantity: 200 mg/g (equivalent: methyl aminolevulinate, qty 160 mg/g) - cream - excipient ingredients: self-emulsifying glyceryl monostearate; cetostearyl alcohol; peg-40 stearate; methyl hydroxybenzoate; propyl hydroxybenzoate; disodium edetate; glycerol; white soft paraffin; cholesterol; isopropyl myristate; arachis oil; almond oil; oleyl alcohol; purified water - treatment of thin or non-hyperkeratotic and non-pigmented actinic keratoses on the face and scalp when other registered therapies are unacceptable. primary treatment of superficial and/or nodular basal cell carcinoma where surgery is considered inappropriate. treatment of biopsy-proven squamous cell carcinoma in situ (bowen's disease), where surgery is considered inappropriate. lumexia is indicated in adults above 18 years of age.

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

galderma australia pty ltd - methyl aminolevulinate hydrochloride, quantity: 200 mg/g (equivalent: methyl aminolevulinate, qty 160 mg/g) - cream - excipient ingredients: self-emulsifying glyceryl monostearate; cetostearyl alcohol; peg-40 stearate; methyl hydroxybenzoate; propyl hydroxybenzoate; disodium edetate; glycerol; white soft paraffin; cholesterol; isopropyl myristate; arachis oil; almond oil; oleyl alcohol; purified water - treatment of thin or non-hyperkeratotic and non-pigmented actinic keratoses on the face and scalp when other registered therapies are unacceptable. primary treatment of superficial and/or nodular basal cell carcinoma where surgery is considered inappropriate. treatment of biopsy-proven squamous cell carcinoma in situ (bowen's disease), where surgery is considered inappropriate. metvix is indicated in adults above 18 years of age.