오스트레일리아 - 영어 - 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.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

aspen pharmacare australia pty ltd - melphalan, quantity: 2 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; crospovidone; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; macrogol 400 - alkeran is indicated for the palliative treatment of multiple myeloma and advanced ovarian adenocarcinoma. alkeran has a significant therapeutic effect in a proportion of patients suffering from advanced breast carcinoma and may be used in the treatment of polycythaemia vera.

유럽 연합 - 영어 - EMA (European Medicines Agency)

eagle laboratories ltd.    - topotecan (as hydrochloride) - carcinoma; small cell lung carcinoma - antineoplastic and immunomodulating agents - topotecan monotherapy is indicated for the treatment of patients with relapsed small cell lung cancer (sclc) for whom re-treatment with the first-line regimen is not considered appropriate.topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with stage ivb disease. patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

abraxis bioscience australia pty ltd - paclitaxel, quantity: 100 mg - injection, powder for - excipient ingredients: albumin; sodium octanoate; sodium acetyltryptophanate - metastatic breast cancer abraxane is indicated for the treatment of metastatic carcinoma of the breast after failure of anthracycline therapy. non-small cell lung cancer abraxane, in combination with carboplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation. metastatic adenocarcinoma of the pancreas abraxane, in combination with gemcitabine, is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

aspen pharmacare australia pty ltd - melphalan, quantity: 50 mg - injection, powder for - excipient ingredients: povidone; hydrochloric acid - for the treatment of patients with multiple myeloma for whom oral therapy is not appropriate

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

abraxis bioscience australia pty ltd - paclitaxel, quantity: 250 mg - injection, powder for - excipient ingredients: albumin; sodium octanoate; sodium acetyltryptophanate - metastatic breast cancer abraxane is indicated for the treatment of metastatic carcinoma of the breast after failure of anthracycline therapy. non-small cell lung cancer abraxane, in combination with carboplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation. metastatic adenocarcinoma of the pancreas abraxane, in combination with gemcitabine, is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas.

유럽 연합 - 영어 - EMA (European Medicines Agency)

actavis group ptc ehf - topotecan - uterine cervical neoplasms; small cell lung carcinoma - antineoplastic agents - topotecan monotherapy is indicated for the treatment of patients with relapsed small cell lung cancer [sclc] for whom re-treatment with the first-line regimen is not considered appropriate. topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with stage ivb disease. patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination.,

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

viatris pty ltd - cladribine, quantity: 2 mg/ml - injection, solution - excipient ingredients: sodium chloride; sodium hydroxide; hydrochloric acid; water for injections - litak is indicated for the treatment of hairy cell leukaemia and the second line treatment of lymphoplasmacytic lymphoma (waldernstorm's macroglobulinaemia), i.e. after failure of alkylating agents.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

emcure pharmaceuticals pty ltd - melphalan hydrochloride, quantity: 55.97 mg (equivalent: melphalan, qty 50 mg) - injection, diluent for - excipient ingredients: sodium citrate dihydrate; ethanol; water for injections; propylene glycol - for?the?treatment?of?patients?with?multiple?myeloma?for?whom?oral therapy?is?not?appropriate

유럽 연합 - 영어 - EMA (European Medicines Agency)

sanofi b.v. - alglucosidase alfa - glycogen storage disease type ii - other alimentary tract and metabolism products, - myozyme is indicated for long-term enzyme-replacement therapy (ert) in patients with a confirmed diagnosis of pompe disease (acid-α-glucosidase deficiency).in patients with late-onset pompe disease the evidence of efficacy is limited.