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.

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

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.,

Australia - English - 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.

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.,