Ireland - English - HPRA (Health Products Regulatory Authority)

fresenius kabi oncology plc - topotecan hydrochloride equivalent to topotecan - concentrate for soln for inf - 1 mg/ml - other antineoplastic agents

Malta - English - Medicines Authority

fresenius kabi oncology plc lion court, farnham road, bordon, hampshire, gu35 0nf, united kingdom - topotecan - concentrate for solution for infusion - topotecan 1 mg/ml - antineoplastic agents

Malta - English - Medicines Authority

fresenius kabi oncology plc lion court, farnham road, bordon, hampshire, gu35 0nf, united kingdom - topotecan - concentrate for solution for infusion - topotecan 1 mg/ml - antineoplastic agents

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

fresenius kabi usa, llc - topotecan hydrochloride (unii: 956s425zcy) (topotecan - unii:7m7ykx2n15) - topotecan 4 mg in 4 ml - topotecan hydrochloride for injection, as a single agent, is indicated for the treatment of patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy. topotecan hydrochloride for injection, as a single agent, is indicated for the treatment of patients with small cell lung cancer (sclc) with platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy. topotecan hydrochloride for injection in combination with cisplatin is indicated for the treatment of patients with stage iv-b, recurrent, or persistent cervical cancer not amenable to curative treatment. topotecan hydrochloride is contraindicated in patients who have a history of severe hypersensitivity reactions to topotecan. reactions have included anaphylactoid reactions [see adverse reactions (6.2)] . risk summary based on animal data and its mechanism of action, topotecan hydrochloride can cause fetal harm when administered to a pregnant woman. there are no ava

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

fresenius kabi usa, llc - topotecan hydrochloride (unii: 956s425zcy) (topotecan - unii:7m7ykx2n15) - topotecan 4 mg in 4 ml - topotecan hydrochloride for injection, as a single agent, is indicated for the treatment of patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy. topotecan hydrochloride for injection, as a single agent, is indicated for the treatment of patients with small cell lung cancer (sclc) with platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy. topotecan hydrochloride for injection in combination with cisplatin is indicated for the treatment of patients with stage iv-b, recurrent, or persistent cervical cancer not amenable to curative treatment. topotecan hydrochloride is contraindicated in patients who have a history of severe hypersensitivity reactions to topotecan. reactions have included anaphylactoid reactions [see adverse reactions (6.2)] . risk summary based on animal data and its mechanism of action, topotecan hydrochloride can cause fetal harm when administered to a pregnant woman. there are no ava

European Union - English - 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.,

European Union - English - 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.

European Union - English - EMA (European Medicines Agency)

teva b.v. - topotecan - ovarian neoplasms; uterine cervical neoplasms; small cell lung carcinoma - antineoplastic agents - topotecan monotherapy is indicated for the treatment of: , patients with metastatic carcinoma of the ovary after failure of first line or subsequent therapy;, 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.,

European Union - English - 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.,

United States - English - 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