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.

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

accelagen pty ltd - oseltamivir phosphate, quantity: 59.1 mg (equivalent: oseltamivir, qty mg) - capsule, hard - excipient ingredients: titanium dioxide; croscarmellose sodium; povidone; sodium stearylfumarate; gelatin; pregelatinised maize starch; iron oxide black; purified talc; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; potassium hydroxide - talminex is indicated for the treatment of infections due to influenza a and b viruses in adults and children including full-term neonates. treatment should commence as soon as possible, but no later than 48 hours after the onset of the initial symptoms of infection.,talminex is indicated for the prevention of influenza in adults and children aged 1 year and older. vaccination is the preferred method of routine prophylaxis against infection with influenza virus.

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

accelagen pty ltd - oseltamivir phosphate, quantity: 39.4 mg (equivalent: oseltamivir, qty mg) - capsule, hard - excipient ingredients: gelatin; pregelatinised maize starch; titanium dioxide; iron oxide red; povidone; sodium stearylfumarate; iron oxide yellow; croscarmellose sodium; purified talc; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - talminex is indicated for the treatment of infections due to influenza a and b viruses in adults and children including full-term neonates. treatment should commence as soon as possible, but no later than 48 hours after the onset of the initial symptoms of infection.,talminex is indicated for the prevention of influenza in adults and children aged 1 year and older. vaccination is the preferred method of routine prophylaxis against infection with influenza virus.

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

accelagen pty ltd - oseltamivir phosphate, quantity: 98.5 mg (equivalent: oseltamivir, qty mg) - capsule, hard - excipient ingredients: iron oxide red; croscarmellose sodium; purified talc; iron oxide black; gelatin; titanium dioxide; pregelatinised maize starch; iron oxide yellow; sodium stearylfumarate; povidone; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; potassium hydroxide - talminex is indicated for the treatment of infections due to influenza a and b viruses in adults and children including full-term neonates. treatment should commence as soon as possible, but no later than 48 hours after the onset of the initial symptoms of infection.,talminex is indicated for the prevention of influenza in adults and children aged 1 year and older. vaccination is the preferred method of routine prophylaxis against infection with influenza virus.

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

seqirus pty ltd - influenza virus haemagglutinin, quantity: 15 microgram - injection, suspension - excipient ingredients: sodium chloride; dibasic sodium phosphate; monobasic sodium phosphate; potassium chloride; monobasic potassium phosphate; calcium chloride dihydrate; water for injections - for the prevention of influenza caused by influenza virus, types a and b contained in the vaccine. the vaccine is indicated for use only in persons aged 5 years and over. for full details regarding recommendations for influenza vaccination, please refer to the relevant national immunisation guidelines.

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

juno pharmaceuticals pty ltd - pemetrexed disodium hemipentahydrate, quantity: 604.05 mg (equivalent: pemetrexed, qty 500 mg) - injection, powder for - excipient ingredients: mannitol; hydrochloric acid; nitrogen; sodium hydroxide - pemetrexed juno, in combination with cisplatin, is indicated for the treatment of patients with malignant pleural mesothelioma. non-small cell lung cancer pemetrexed juno 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. pemetrexed juno 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)

juno pharmaceuticals pty ltd - pemetrexed disodium hemipentahydrate, quantity: 120.81 mg (equivalent: pemetrexed, qty 100 mg) - injection, powder for - excipient ingredients: sodium hydroxide; nitrogen; mannitol; hydrochloric acid - pemetrexed juno, in combination with cisplatin, is indicated for the treatment of patients with malignant pleural mesothelioma. non-small cell lung cancer pemetrexed juno 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. pemetrexed juno 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)

sanofi-aventis australia pty ltd - riluzole -