欧盟 - 英文 - 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.,

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - topotecan hydrochloride, quantity: 4.346 mg - injection, powder for - excipient ingredients: mannitol; tartaric acid; hydrochloric acid; sodium hydroxide - topotecan is indicated as single agent therapy for the treatment of patients with: - small cell lung carcinoma, after failure of first line chemotherapy. - metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.

欧盟 - 英文 - EMA (European Medicines Agency)

pfizer europe ma eeig - topotecan - uterine cervical neoplasms; small cell lung carcinoma - other 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.,

加拿大 - 英文 - Health Canada

sandoz canada incorporated - topotecan (topotecan hydrochloride) - solution - 1mg - topotecan (topotecan hydrochloride) 1mg - antineoplastic agents

加拿大 - 英文 - Health Canada

sandoz canada incorporated - topotecan (topotecan hydrochloride) - powder for solution - 4mg - topotecan (topotecan hydrochloride) 4mg - antineoplastic agents

美国 - 英文 - NLM (National Library of Medicine)

sandoz inc - topotecan hydrochloride (unii: 956s425zcy) (topotecan - unii:7m7ykx2n15) - topotecan hydrochloride 1 mg in 1 ml - topotecan injection is indicated for the treatment of: - small cell lung cancer sensitive disease after failure of first-line chemotherapy. in clinical studies submitted to support approval, sensitive disease was defined as disease responding to chemotherapy but subsequently progressing at least 60 days (in the phase 3 study) or at least 90 days (in the phase 2 studies) after chemotherapy [see clinical studies (14) ] . topotecan injection in combination with cisplatin is indicated for the treatment of: - stage iv-b, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy. topotecan injection is contraindicated in patients who have a history of severe hypersensitivity reactions (e.g., anaphylactoid reactions) to topotecan or to any of its ingredients. topotecan injection should not be used in patients with severe bone marrow depression. pregnancy category d [see warnings and precautions (5.4) ]. topotecan injection can cause fetal harm

美国 - 英文 - NLM (National Library of Medicine)

bedford laboratories - topotecan hydrochloride (unii: 956s425zcy) (topotecan - unii:7m7ykx2n15) - topotecan 4 mg in 4 ml - topotecan hydrochloride for injection is indicated for the treatment of:  - small cell lung cancer sensitive disease after failure of first-line chemotherapy. in clinical studies submitted to support approval, sensitive disease was defined as disease responding to chemotherapy but subsequently progressing at least 60 days (in the phase 3 study) or at least 90 days (in the phase 2 studies) after chemotherapy [see clinical studies (14) ].  - topotecan hydrochloride for injection in combination with cisplatin is indicated for the treatment of: stage iv-b, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy.  topotecan hydrochloride for injection is contraindicated in patients who have a history of severe hypersensitivity reactions (e.g., anaphylactoid reactions) to topotecan or to any of its ingredients. topotecan hydrochloride for injection should not be used in patients with severe bone marrow depression.  pregnancy category d [see

加拿大 - 英文 - Health Canada

pfizer canada ulc - topotecan (topotecan hydrochloride) - solution - 1mg - topotecan (topotecan hydrochloride) 1mg - antineoplastic agents

加拿大 - 英文 - Health Canada

teva canada limited - topotecan (topotecan hydrochloride) - solution - 1mg - topotecan (topotecan hydrochloride) 1mg - antineoplastic agents

加拿大 - 英文 - Health Canada

fresenius kabi canada ltd - topotecan (topotecan hydrochloride) - powder for solution - 4mg - topotecan (topotecan hydrochloride) 4mg - antineoplastic agents