Malta - English - Medicines Authority

strides arcolab international limited - mitoxantrone 2 mg/ml - concentrate for solution for infusion

European Union - English - EMA (European Medicines Agency)

teva b.v. - lipegfilgrastim - neutropenia - immunostimulants, , colony stimulating factors - lonquex is indicated in adults and in children 2 years of age and older for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

European Union - English - EMA (European Medicines Agency)

teva b.v. - doxorubicin hydrochloride - breast neoplasms - antineoplastic agents - myocet liposomal, in combination with cyclophosphamide, is indicated for the first-line treatment of metastatic breast cancer in adult women.

European Union - English - EMA (European Medicines Agency)

dompé biotec s.p.a. - pegfilgrastim - neutropenia; cancer - immunostimulants, - reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

European Union - English - EMA (European Medicines Agency)

amgen europe b.v. - pegfilgrastim - neutropenia - immunostimulants, - reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes)

European Union - English - EMA (European Medicines Agency)

norton healthcare ltd. - paclitaxel - sarcoma, kaposi; carcinoma, non-small-cell lung; ovarian neoplasms; breast neoplasms - antineoplastic agents - paxene is indicated for the treatment of patients with:• advanced aids-related kaposi's sarcoma (aids-ks) who have failed prior liposomal anthracycline therapy;• metastatic carcinoma of the breast (mbc) who have failed, or are not candidates for standard anthracycline-containing therapy;• advanced carcinoma of the ovary (aoc) or with residual disease (> 1 cm) after initial laparotomy, in combination with cisplatin as first-line treatment;• metastatic carcinoma of the ovary (moc) after failure of platinum-containing combination therapy without taxanes as second-line treatment;• non-small cell lung carcinoma (nsclc) who are not candidates for potentially curative surgery and/or radiation therapy, in combination with cisplatin. limited efficacy data supports this indication (see section 5.1).

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

cipla australia pty ltd - bleomycin sulfate, quantity: 15000 iu - injection, powder for - excipient ingredients: sodium hydroxide; hydrochloric acid - palliation and treatment adjuvant to surgery and radiation therapy of the following neoplasms: squamous cell carcinoma of the skin, head and neck, and oesophagus (primary indication). squamous cell carcinoma of the larynx, penis and uterine cervix. squamous cell carcinoma of the bronchus (response infrequent). choriocarcinoma and embryonal cell carcinoma of the testis. advanced hodgkin's disease and other lymphomas. mycosis fungoides note. use of bleomycin after radiation therapy is less successful than use before radiation therapy. bleomycin is bone marrow sparing and may be used when other cytotoxic agents are contraindicated.

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

sun pharma anz pty ltd - doxorubicin hydrochloride, quantity: 2 mg/ml - injection - excipient ingredients: hydrochloric acid; sodium hydroxide; sucrose; histidine; cholesterol; sodium methoxy peg-40-carbonyl-distearoylphosphatidylethanolamine; hydrogenated soy phosphatidylcholine; ammonium sulfate; ethanol; water for injections - liposomal doxorubicin sun, as monotherapy, is indicated for the treatment of metastatic breast cancer.,liposomal doxorubicin sun is also indicated for the treatment of:,? advanced epithelial ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen.,? aids-related kaposi's sarcoma (ks) in patients with low cd4 counts (<200 lymphocytes/mm3) and extensive mucocutaneous or visceral disease.,liposomal doxorubicin sun may be used as first-line systemic chemotherapy, or as second line chemotherapy in aids-ks patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and doxorubicin (or other anthracycline).,liposomal doxorubicin sun is also indicated, in combination with bortezomib, for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant.

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

sun pharma anz pty ltd - doxorubicin hydrochloride, quantity: 2 mg/ml - injection - excipient ingredients: water for injections; cholesterol; ethanol; hydrogenated soy phosphatidylcholine; ammonium sulfate; sodium methoxy peg-40-carbonyl-distearoylphosphatidylethanolamine; histidine; hydrochloric acid; sodium hydroxide; sucrose - liposomal doxorubicin sun, as monotherapy, is indicated for the treatment of metastatic breast cancer.,liposomal doxorubicin sun is also indicated for the treatment of:,? advanced epithelial ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen.,? aids-related kaposi's sarcoma (ks) in patients with low cd4 counts (<200 lymphocytes/mm3) and extensive mucocutaneous or visceral disease.,liposomal doxorubicin sun may be used as first-line systemic chemotherapy, or as second line chemotherapy in aids-ks patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and doxorubicin (or other anthracycline). liposomal doxorubicin sun is also indicated, in combination with bortezomib, for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant.

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

juno pharmaceuticals pty ltd - bleomycin sulfate, quantity: 15000 iu - injection, powder for - excipient ingredients: water for injections; sodium hydroxide; hydrochloric acid - palliation and treatment adjuvant to surgery and radiation therapy of the following neoplasms: = squamous cell carcinoma of the skin, head and neck, and oesophagus (primary indication). = squamous cell carcinoma of the larynx, penis and uterine cervix. = squamous cell carcinoma of the bronchus (response infrequent). = choriocarcinoma and embryonal cell carcinoma of the testis. = advanced hodgkin's disease and other lymphomas. = mycosis fungoides.,note. use of bleomycin after radiation therapy is less successful than use before radiation therapy. bleomycin is bone marrow sparing and may be used when other cytotoxic agents are contraindicated.