Ireland - English - HPRA (Health Products Regulatory Authority)

martindale pharmaceuticals ltd - topotecan hydrochloride - pdr/conc/soln for infus - 4 milligram

Ireland - English - HPRA (Health Products Regulatory Authority)

martindale pharmaceuticals ltd - topotecan hydrochloride - pdr/conc/soln for infus - 1 milligram

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

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 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 (see section 5.1).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 (see section 5.1).

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

sandoz pty ltd - topotecan hydrochloride, quantity: 1 mg - injection, powder for - excipient ingredients: hydrochloric acid; tartaric acid; mannitol; sodium hydroxide - for 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. 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)

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

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)

northstar rxllc - doxorubicin hydrochloride (unii: 82f2g7bl4e) (doxorubicin - unii:80168379ag) - doxorubicin hydrochloride 2 mg in 1 ml - doxorubicin hydrochloride liposome injection is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. doxorubicin hydrochloride liposome injection is indicated for the treatment of aids-related kaposi’s sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy. doxorubicin hydrochloride liposome injection, in combination with bortezomib, is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy. doxorubicin hydrochloride liposome injection is contraindicated in patients who have a history of severe hypersensitivity reactions, including anaphylaxis, to doxorubicin hydrochloride [see warnings and precautions (5.2)]. risk summary based on findings in animals and its mechanism of action, doxorubicin hydrochloride liposome injection can cause fetal harm when administered to a pregnant woman; avoid the

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

dr. reddy's laboratories inc - doxorubicin hydrochloride (unii: 82f2g7bl4e) (doxorubicin - unii:80168379ag) - doxorubicin hydrochloride 2 mg in 1 ml - doxorubicin hydrochloride liposome injection is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. doxorubicin hydrochloride liposome injection is indicated for the treatment of aids-related kaposi’s sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy. doxorubicin hydrochloride liposome injection, in combination with bortezomib, is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy. doxorubicin hydrochloride liposome injection is contraindicated in patients who have a history of severe hypersensitivity reactions, including anaphylaxis, to doxorubicin hydrochloride [see warnings and precautions (5.2)]. risk summary based on findings in animals and its mechanism of action, doxorubicin hydrochloride liposome injection can cause fetal harm when administered to a pregnant woman; avoid the

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

sun pharmaceutical industries, inc. - doxorubicin hydrochloride (unii: 82f2g7bl4e) (doxorubicin - unii:80168379ag) - doxorubicin hydrochloride 2 mg in 1 ml - doxorubicin hydrochloride liposome injection is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. doxorubicin hydrochloride liposome injection is indicated for the treatment of aids-related kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy. doxorubicin hydrochloride liposome injection, in combination with bortezomib, is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy. doxorubicin hydrochloride liposome injection is contraindicated in patients who have a history of severe hypersensitivity reactions, including anaphylaxis, to doxorubicin hydrochloride [see warnings and precautions (5.2)]. risk summary based on findings in animals and its mechanism of action, doxorubicin hydrochloride liposome injection can cause fetal harm when administered to a pregnant woman; avoid the