Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 24 April 2019

Indication(s)



Medicinal product no longer authorised



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.

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Category Value
Agency product number EMEA/H/C/001031
Orphan designation No
Date First Approved 24-07-2009
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Actavis Group PTC ehf