Európai Unió - angol - 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).

Izrael - angol - Ministry of Health

medison pharma ltd - topotecan hydrochloride 4 mg/vial - powder for concentrate for infusion - topotecan - treatment of metastatic carcinoma of the ovary after failure of initial or subsequent therapy.treatment of small cell lung cancer sensitive disease after failure of first line chemotherapy. topotecan 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.

Namíbia - angol - Namibia Medicines Regulatory Council

cipla - medpro (pty) ltd - topotecan hydrochloride - injection - each 5 ml injection vial contains topotecan hydrochloride equivalent to topotecan 1,0 mg

Namíbia - angol - Namibia Medicines Regulatory Council

cipla - medpro (pty) ltd - topotecan hydrochloride - injection - each 10 ml injection vial contains topotecan hydrochloride equivalent to topotecan 4,0 mg

Írország - angol - HPRA (Health Products Regulatory Authority)

accord healthcare limited - topotecan (as hydrochloride) - pdr/conc/soln for infus - 4 milligram

Írország - angol - HPRA (Health Products Regulatory Authority)

pliva pharma limited - topotecan hydrochloride - pdr/conc/soln for infus - 4 milligram

Írország - angol - HPRA (Health Products Regulatory Authority)

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

Írország - angol - HPRA (Health Products Regulatory Authority)

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

Európai Unió - angol - 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.

Írország - angol - HPRA (Health Products Regulatory Authority)

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