Ireland - English - HPRA (Health Products Regulatory Authority)

ebewe pharma ges.m.b.h nfg. kg - topotecan hydrochloride - concentrate for soln for inf - 1 mg/ml

Israel - English - Ministry of Health

novartis israel ltd - topotecan as hydrochloride - hard gelatin capsules - topotecan as hydrochloride 0.25 mg - topotecan - topotecan - 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.

Israel - English - Ministry of Health

novartis israel ltd - topotecan as hydrochloride - hard gelatin capsules - topotecan as hydrochloride 1 mg - topotecan - topotecan - 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.

European Union - English - EMA (European Medicines Agency)

sandoz pharmaceuticals d.d. - topotecan - ovarian neoplasms; uterine cervical neoplasms; small cell lung carcinoma - antineoplastic agents - hycamtin capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (sclc) for whom re-treatment with the first-line regimen is not considered appropriate.topotecan is indicated for the treatment of patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.hycamtin capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (sclc) for whom re-treatment with the first-line regimen is not considered appropriate.

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

novartis pharmaceuticals corporation - topotecan hydrochloride (unii: 956s425zcy) (topotecan - unii:7m7ykx2n15) - topotecan 4 mg in 4 ml - hycamtin® 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. hycamtin 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. hycamtin 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. hycamtin 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, hycamtin can cause fetal harm when administered to a pregnant woman. there are no available clinical data on the use of hycamtin in pregnancy. topotecan cau

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

novartis pharmaceuticals corporation - topotecan hydrochloride (unii: 956s425zcy) (topotecan - unii:7m7ykx2n15) - topotecan .25 mg - hycamtin® capsules are indicated for the treatment of relapsed small cell lung cancer (sclc) in patients with a prior complete or partial response and who are at least 45 days from the end of first-line chemotherapy. hycamtin 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, hycamtin can cause fetal harm when administered to a pregnant woman. there are no available clinical data on the use of hycamtin in pregnancy. topotecan caused embryolethality, fetotoxicity, and teratogenicity in rats and rabbits when administered during organogenesis at doses similar to the clinical dose (see data) . advise pregnant women of the potential risk to a fetus. in the u.s. general population, the background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. data animal data in

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

a a h pharmaceuticals ltd - topotecan hydrochloride - powder for solution for infusion - 1mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

a a h pharmaceuticals ltd - topotecan hydrochloride - powder for solution for infusion - 4mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

accord healthcare ltd - topotecan hydrochloride - solution for infusion - 1mg/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

teva uk ltd - topotecan hydrochloride - solution for infusion - 1mg/1ml