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

teva pharma australia pty ltd - paclitaxel, quantity: 30 mg - injection, concentrated - excipient ingredients: ethanol; peg-35 castor oil; citric acid - primary treatment of ovarian cancer in combination with a platinum agent.. treatment of metastatic carcinoma of the ovary and of the breast after failure of standard therapy.. adjuvant treatment of node positive breast cancer administered sequentially to doxorubicin and cyclophosphamide.. treatment of metastatic cancer of the breast, in combination with trastuzumab (herceptin), in patients who have tumours that overexpress her-2 and who have not received previous chemotherapy for their metatastic disease.. paclitaxin, in combination with gemcitabine (gemzar), is indicated for the treatment of patients with unresectable, locally recurrent or . metastatic breast cancer who have relapsed following adjuvant/ neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated.. treatment of non-small cell lung cancer (nsclc).

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

teva pharma australia pty ltd - paclitaxel, quantity: 100 mg - injection, concentrated - excipient ingredients: peg-35 castor oil; ethanol; citric acid - primary treatment of ovarian cancer in combination with a platinum agent.. treatment of metastatic carcinoma of the ovary and of the breast after failure of standard therapy.. adjuvant treatment of node positive breast cancer administered sequentially to doxorubicin and cyclophosphamide.. treatment of metastatic cancer of the breast, in combination with trastuzumab (herceptin), in patients who have tumours that overexpress her-2 and who have not received previous chemotherapy for their metatastic disease.. paclitaxin, in combination with gemcitabine (gemzar), is indicated for the treatment of patients with unresectable, locally recurrent or . metastatic breast cancer who have relapsed following adjuvant/ neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated.. treatment of non-small cell lung cancer (nsclc).

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

medis pharma pty ltd - gemcitabine hydrochloride, quantity: 228 mg (equivalent: gemcitabine, qty 200 mg) - injection, powder for - excipient ingredients: mannitol; sodium hydroxide; sodium acetate trihydrate - treatment of patients with locally advanced or metastatic non-small cell lung cancer. treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. treatment of patients with fu refractory pancreatic cancer. treatment of patients with bladder cancer, alone or in combination with cisplatin. treatment, in combination with paclitaxel, of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/ neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated. treatment, in combination with carboplatin, of patients with recurrent epithelial ovarian carcinoma, who have relapsed >six months following platinum based therapy.

Malta - English - Medicines Authority

cis bio international route nationale 306-saclay, bp 32, 91192, gif-sur-yvette cedex, france - fluorocholine - solution for injection - fluorocholine (18-f) 225 mbq/ml - diagnostic radiopharmaceuticals

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

wockhardt bio pty ltd - docetaxel, quantity: 160 mg - injection, concentrated - excipient ingredients: ethanol absolute; polysorbate 80; 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)

wockhardt bio pty ltd - docetaxel, quantity: 20 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)

wockhardt bio pty ltd - docetaxel, quantity: 20 mg - injection, concentrated - excipient ingredients: ethanol absolute; citric acid monohydrate; polysorbate 80 - 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: ethanol absolute; citric acid monohydrate; polysorbate 80 - 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: 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.