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Topotecan Eagle

Active Substance: topotecan hydrochloride
Common Name: topotecan
ATC Code: L01XX17
Marketing Authorisation Holder: Eagle Laboratories Ltd.   
Active Substance: topotecan hydrochloride
Status: Withdrawn
Authorisation Date: 2011-12-22
Therapeutic Area: Small Cell Lung Carcinoma Carcinoma
Pharmacotherapeutic Group: Antineoplastic and immunomodulating agents

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.

The marketing authorisation for Topotecan Eagle has been withdrawn at the request of the marketing authorisation holder.

Source: European Medicines Agency

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