This is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine. If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Therapeutic Indication
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.
Therapeutic Area (MeSH)
ATC Code
L01CE01
ATC Item
N/A
Pharmacotherapeutic Group
Antineoplastic agents
Active Substance (Summary)
INN / Common Names
EMA Name
Topotecan Teva
Medicine Name
Topotecan Teva
Aliases
N/ANo risk management plan link.
