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

southern cross pharma pty ltd - aprepitant, quantity: 165 mg - capsule, hard - excipient ingredients: titanium dioxide; microcrystalline cellulose; gelatin; hypromellose; poloxamer; sucrose; sodium lauryl sulfate; indigo carmine aluminium lake; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - aprepitant in combination with other antiemetic agents, is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of:,? highly emetogenic cancer chemotherapy.,? moderately emetogenic cancer chemotherapy,aprepitant is indicated for the prevention of postoperative nausea and vomiting.

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

southern cross pharma pty ltd - aprepitant, quantity: 125 mg - capsule, hard - excipient ingredients: microcrystalline cellulose; sucrose; hypromellose; poloxamer; gelatin; sodium lauryl sulfate; titanium dioxide; iron oxide red; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - aprepitant in combination with other antiemetic agents, is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of:,? highly emetogenic cancer chemotherapy.,? moderately emetogenic cancer chemotherapy,aprepitant is indicated for the prevention of postoperative nausea and vomiting.

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

southern cross pharma pty ltd - aprepitant, quantity: 40 mg - capsule, hard - excipient ingredients: iron oxide yellow; hypromellose; poloxamer; sucrose; gelatin; sodium lauryl sulfate; titanium dioxide; microcrystalline cellulose; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - aprepitant in combination with other antiemetic agents, is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of:,? highly emetogenic cancer chemotherapy.,? moderately emetogenic cancer chemotherapy,aprepitant is indicated for the prevention of postoperative nausea and vomiting.

European Union - English - EMA (European Medicines Agency)

roche registration gmbh - rituximab - lymphoma, non-hodgkin; arthritis, rheumatoid; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents - mabthera is indicated in adults for the following indications:non‑hodgkin’s lymphoma (nhl)mabthera is indicated for the treatment of previously untreated adult patients with stage iii‑iv follicular lymphoma in combination with chemotherapy.mabthera maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy.mabthera monotherapy is indicated for treatment of adult patients with stage iii‑iv follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy.mabthera is indicated for the treatment of adult patients with cd20 positive diffuse large b cell non‑hodgkin’s lymphoma in combination with chop (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.mabthera in combination with chemotherapy is indicated for the treatment of paediatric patients (aged ≥ 6 months  to < 18 years old) with previously untreated advanced stage cd20 positive diffuse large b-cell lymphoma (dlbcl), burkitt lymphoma (bl)/burkitt leukaemia (mature b-cell acute leukaemia) (bal) or burkitt-like lymphoma (bll).chronic lymphocytic leukaemia (cll)mabthera in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory cll. only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including mabthera or patients refractory to previous mabthera plus chemotherapy.rheumatoid arthritismabthera in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease‑modifying anti‑rheumatic drugs (dmard) including one or more tumour necrosis factor (tnf) inhibitor therapies.mabthera has been shown to reduce the rate of progression of joint damage as measured by x‑ray and to improve physical function, when given in combination with methotrexate.granulomatosis with polyangiitis and microscopic polyangiitismabthera, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (wegener’s) (gpa) and microscopic polyangiitis (mpa).mabthera, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ≥ 2 to < 18 years old) with severe, active gpa (wegener’s) and mpa.pemphigus vulgarismabthera is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (pv).

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

pfizer australia pty ltd - gemcitabine hydrochloride, quantity: 2.277 g - injection, solution - excipient ingredients: water for injections; hydrochloric acid; sodium hydroxide - dbl gemcitabine injection is indicated: 1. for treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc). 2. for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. 3. for treatment of patients with fu refractory pancreatic cancer. 4. alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer. 5. in combination with paclitaxel, 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. 6. in combination with carboplatin, for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum-based therapy.

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

pfizer australia pty ltd - gemcitabine hydrochloride, quantity: 1.139 g - injection, solution - excipient ingredients: hydrochloric acid; sodium hydroxide; water for injections - dbl gemcitabine injection is indicated: 1. for treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc). 2. for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. 3. for treatment of patients with fu refractory pancreatic cancer. 4. alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer. 5. in combination with paclitaxel, 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. 6. in combination with carboplatin, for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum-based therapy.

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

pfizer australia pty ltd - gemcitabine hydrochloride, quantity: 227.7 mg - injection, solution - excipient ingredients: water for injections; hydrochloric acid; sodium hydroxide - dbl gemcitabine injection is indicated: 1. for treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc). 2. for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. 3. for treatment of patients with fu refractory pancreatic cancer. 4. alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer. 5. in combination with paclitaxel, 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. 6. in combination with carboplatin, for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum-based therapy.

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

fresenius kabi australia pty ltd - paclitaxel, quantity: 300 mg - injection, concentrated - excipient ingredients: ethanol; citric acid; peg-35 castor oil - primary treatment of ovarian cancer in combination with a platinum agent. treatment of metastatic carcinoma of the ovary after failure of standard therapy. treatment of metastatic carcinoma 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 over-express her-2 and who have not received previous chemotherapy for their metastatic disease. in combination with gemcitabine (gemzar), 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)

fresenius kabi australia pty ltd - paclitaxel, quantity: 100.2 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 after failure of standard therapy. treatment of metastatic carcinoma 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 over-express her-2 and who have not received previous chemotherapy for their metastatic disease. in combination with gemcitabine (gemzar), 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)

fresenius kabi australia pty ltd - paclitaxel, quantity: 30 mg - injection, concentrated - excipient ingredients: peg-35 castor oil; citric acid; ethanol - primary treatment of ovarian cancer in combination with a platinum agent. treatment of metastatic carcinoma of the ovary after failure of standard therapy. treatment of metastatic carcinoma 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 over-express her-2 and who have not received previous chemotherapy for their metastatic disease. in combination with gemcitabine (gemzar), 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).