This is a summary of the European public assessment report (EPAR) for Topotecan Hospira. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Topotecan Hospira.
Therapeutic Indication
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.
Therapeutic Area (MeSH)
ATC Code
L01CE01
ATC Item
N/A
Pharmacotherapeutic Group
Other antineoplastic agents
Active Substance (Summary)
INN / Common Names
EMA Name
Topotecan Hospira
Medicine Name
Topotecan Hospira
Aliases
N/ANo risk management plan link.
