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

biogen australia pty ltd - daclizumab -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

biocon sdn bhd - bevacizumab -

United States - English - NLM (National Library of Medicine)

medimmune, llc - palivizumab (unii: dq448mw7ks) (palivizumab - unii:dq448mw7ks) - palivizumab 100 mg in 1 ml - 1 indications and usage synagis is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (rsv) in pediatric patients: limitations of use: the safety and efficacy of synagis have not been established for treatment of rsv disease [see warnings and precautions (5.4)] . synagis is contraindicated in children who have had a previous significant hypersensitivity reaction to synagis [see warnings and precautions (5.1)] . risk summary synagis is not indicated for use in females of reproductive potential. risk summary synagis is not indicated for use in females of reproductive potential. the safety and effectiveness of synagis in children older than 24 months of age at the start of dosing have not been established [see clinical studies (14) ] .

Israel - English - Ministry of Health

sanofi israel ltd - caplacizumab - powder and solvent for solution for injection - caplacizumab 10 mg/vial - caplacizumab - cablivi is indicated for the treatment of adults and adolescents of 12 years of age and older weighing at least 40 kg experiencing an episode of acquired thrombotic thrombocytopenic purpura (attp), in conjunction with plasma exchange and immunosuppression.

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

sanofi-aventis australia pty ltd - caplacizumab, quantity: 10 mg - injection, powder for - excipient ingredients: - cablivi is indicated for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (attp), in conjunction with plasma exchange and immunosuppression.

Israel - English - Ministry of Health

amgen europe b.v. - bevacizumab - concentrate for solution for infusion - bevacizumab 25 mg / 1 ml - bevacizumab - mvasi in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.mvasi in addition to platinum - based chemotherapy is indicated for first - line treatment of adult patients with unresectable advanced metastatic or recurrent non- small cell lung cancer other than predominantly squamous cell histology.mvasi in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer.mvasi in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. mvasi as a single agent, is indicated for the treatment of glioblastoma in patients with progressive disease following prior therapy.mvasi in combination with carboplatin and paclitaxel, is indicated for the front-line treatment of advanced (figo stages iiib, iiic and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer in adult patients who are at high risk for recurrence (residual disease after debulking).mvasi in combination with carboplatin and gemcitabine, is indicated for the treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor-targeted agents.mvasi in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin isindicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents.mvasi in combination with paclitaxel and cisplatin or paclitaxel and topotecan is indicated, in patients who cannot receive platinum therapy, for treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.mvasi, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations.

European Union - English - EMA (European Medicines Agency)

roche registration gmbh - bevacizumab - carcinoma, non-small-cell lung; breast neoplasms; ovarian neoplasms; colorectal neoplasms; carcinoma, renal cell - antineoplastic agents - bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.bevacizumab in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. for further information as to human epidermal growth factor receptor 2 (her2) status.bevacizumab in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline-containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with avastin in combination with capecitabine. for further information as to her2 status.bevacizumab, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology.bevacizumab, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations.bevacizumab in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer.bevacizumab, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer.bevacizumab, in combination with carboplatin and gemcitabine, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents.bevacizumab in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents.bevacizumab, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.

European Union - English - EMA (European Medicines Agency)

centus biotherapeutics europe limited - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell - antineoplastic agents - bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.bevacizumab in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. for further information as to human epidermal growth factor receptor 2 (her2) status, please refer to section 5.1.bevacizumab in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline- containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with equidacent in combination with capecitabine. for further information as to her2 status, please refer to section 5.1.bevacizumab, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology.bevacizumab, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations.bevacizumab in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and/or metastatic renal cell cancer.bevacizumab, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iiib, iiic and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5.1).bevacizumab, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor-targeted agents.bevacizumab, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.

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

cipla australia pty ltd - bevacizumab, quantity: 25 mg/ml - injection, concentrated - excipient ingredients: monobasic sodium phosphate monohydrate; water for injections; dibasic sodium phosphate; polysorbate 20; trehalose dihydrate - metastatic colorectal cancer bevacip (bevacizumab) in combination with fluoropyrimidine-based chemotherapy is indicated for the treatment of patients with metastatic colorectal cancer. locally recurrent or metastatic breast cancer bevacip (bevacizumab) in combination with paclitaxel is indicated for the first-line treatment of metastatic breast cancer in patients in whom an anthracycline-based therapy is contraindicated (see section 5.1 clinical trials). advanced, metastatic or recurrent non-squamous non-small cell lung cancer (nsclc) bevacip (bevacizumab), in combination with carboplatin and paclitaxel, is indicated for first- line treatment of patients with unresectable advanced, metastatic or recurrent, non-squamous, non-small cell lung cancer. advanced and/or metastatic renal cell cancer bevacip (bevacizumab) in combination with interferon alfa-2a is indicated for treatment of patients with advanced and/or metastatic renal cell cancer. grade iv glioma bevacip (bevacizumab) as a single agent, is indicated for the treatment of patients with grade iv glioma after relapse or disease progression after standard therapy, including chemotherapy. epithelial ovarian, fallopian tube or primary peritoneal cancer bevacip (bevacizumab) in combination with carboplatin and paclitaxel, is indicated for first- line treatment of patients with advanced (figo stages iiib, iiic and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer. recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer bevacip (bevacizumab) in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, is indicated for the treatment of patients with first recurrence of platinum-sensitive, epithelial ovarian, fallopian tube, or primary peritoneal cancer who have not received prior bevacizumab or other vegf-targeted angiogenesis inhibitors. bevacip (bevacizumab) in combination with topotecan or pegylated liposomal doxorubicin is indicated for the treatment of patients with recurrent, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received no more than two prior chemotherapy regimens, and have not received any prior anti-angiogenic therapy including bevacizumab. cervical cancer bevacip (bevacizumab) in combination with paclitaxel and cisplatin is indicated for the treatment of persistent, recurrent or metastatic carcinoma of the cervix. bevacip (bevacizumab) in combination with paclitaxel and topotecan is an acceptable alternative where cisplatin is not tolerated or not indicated.

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

cipla australia pty ltd - bevacizumab, quantity: 25 mg/ml - injection, concentrated - excipient ingredients: monobasic sodium phosphate monohydrate; water for injections; trehalose dihydrate; dibasic sodium phosphate; polysorbate 20 - metastatic colorectal cancer bevacip (bevacizumab) in combination with fluoropyrimidine-based chemotherapy is indicated for the treatment of patients with metastatic colorectal cancer. locally recurrent or metastatic breast cancer bevacip (bevacizumab) in combination with paclitaxel is indicated for the first-line treatment of metastatic breast cancer in patients in whom an anthracycline-based therapy is contraindicated (see section 5.1 clinical trials). advanced, metastatic or recurrent non-squamous non-small cell lung cancer (nsclc) bevacip (bevacizumab), in combination with carboplatin and paclitaxel, is indicated for first- line treatment of patients with unresectable advanced, metastatic or recurrent, non-squamous, non-small cell lung cancer. advanced and/or metastatic renal cell cancer bevacip (bevacizumab) in combination with interferon alfa-2a is indicated for treatment of patients with advanced and/or metastatic renal cell cancer. grade iv glioma bevacip (bevacizumab) as a single agent, is indicated for the treatment of patients with grade iv glioma after relapse or disease progression after standard therapy, including chemotherapy. epithelial ovarian, fallopian tube or primary peritoneal cancer bevacip (bevacizumab) in combination with carboplatin and paclitaxel, is indicated for first- line treatment of patients with advanced (figo stages iiib, iiic and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer. recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer bevacip (bevacizumab) in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, is indicated for the treatment of patients with first recurrence of platinum-sensitive, epithelial ovarian, fallopian tube, or primary peritoneal cancer who have not received prior bevacizumab or other vegf-targeted angiogenesis inhibitors. bevacip (bevacizumab) in combination with topotecan or pegylated liposomal doxorubicin is indicated for the treatment of patients with recurrent, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received no more than two prior chemotherapy regimens, and have not received any prior anti-angiogenic therapy including bevacizumab. cervical cancer bevacip (bevacizumab) in combination with paclitaxel and cisplatin is indicated for the treatment of persistent, recurrent or metastatic carcinoma of the cervix. bevacip (bevacizumab) in combination with paclitaxel and topotecan is an acceptable alternative where cisplatin is not tolerated or not indicated.