Skip to Content

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Status: Withdrawn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The marketing authorisation for Topotecan Eagle has been withdrawn at the request of the marketing authorisation holder.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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.