Data from EMA (European Medicines Agency) - Curated by Toby Galbraith - Last updated 12 October 2017


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.

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Category Value
Agency product number EMEA/H/C/001071
Orphan designation No
Date First Approved 21-09-2009
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Teva B.V.