Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 16 April 2018

Indication(s)

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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More information

Category Value
Agency product number EMEA/H/C/002282
Orphan designation No
Date First Approved 06-01-2011
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Actavis Group PTC ehf