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.

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

accord healthcare pty ltd - topotecan hydrochloride, quantity: 1.09 mg (equivalent: topotecan, qty 1 mg) - injection, concentrated - excipient ingredients: tartaric acid; hydrochloric acid; sodium hydroxide; water for injections - topotecan accord 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.,topotecan accord is indicated in combination with cisplatin for the treatment of patients with:,? histologically confirmed stage iv-b, recurrent, or persistent carcinoma of the cervix, which is not amenable to curative treatment with surgery and/or radiation therapy.

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

accord healthcare pty ltd - topotecan hydrochloride, quantity: 4.346 mg (equivalent: topotecan, qty 4 mg) - injection, concentrated - excipient ingredients: hydrochloric acid; sodium hydroxide; water for injections; tartaric acid - topotecan accord 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.,topotecan accord is indicated in combination with cisplatin for the treatment of patients with:,? histologically confirmed stage iv-b, recurrent, or persistent carcinoma of the cervix, which is not amenable to curative treatment with surgery and/or radiation therapy.

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)

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.,

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - topotecan (as hydrochloride) - concentrate for solution for infusion - 1 milligram(s)/millilitre - other antineoplastic agents; topotecan

Israel - English - Ministry of Health

novartis israel ltd - topotecan as hydrochloride - powder for solution for infusion - topotecan as hydrochloride 4 mg/vial - topotecan - topotecan - 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.

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare limited - topotecan (as hydrochloride) - concentrate for solution for infusion - 1 milligram(s)/millilitre - other antineoplastic agents; topotecan

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

sagent pharmaceuticals - topotecan hydrochloride (unii: 956s425zcy) (topotecan - unii:7m7ykx2n15) - topotecan 1 mg in 1 ml - topotecan injection, as a single agent, is indicated for the treatment of patients with metastatic carcinoma of the ovary after disease progression on or after initial or subsequent chemotherapy. topotecan injection, as a single agent, is indicated for the treatment of patients with small cell lung cancer with platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy. topotecan injection in combination with cisplatin is indicated for the treatment of patients with stage iv-b, recurrent, or persistent carcinoma of the cervix not amenable to curative treatment. topotecan injection is contraindicated in patients who have a history of severe hypersensitivity reactions to topotecan. risk summary based on animal data, topotecan can cause fetal harm when administered to a pregnant woman. topotecan caused embryolethality, fetotoxicity, and teratogenicity in rats and rabbits when administered during organogenesis at doses similar to the clinical dose [see data]. there are