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Paxene

Active Substance: paclitaxel
Common Name: paclitaxel
ATC Code: L01CD01
Marketing Authorisation Holder: Norton Healthcare Ltd.
Active Substance: paclitaxel
Status: Withdrawn
Authorisation Date: 1999-07-19
Therapeutic Area: Carcinoma, Non-Small-Cell Lung Ovarian Neoplasms Breast Neoplasms Sarcoma, Kaposi
Pharmacotherapeutic Group: Antineoplastic agents

Therapeutic Indication

Paxene is indicated for the treatment of patients with:
• advanced AIDS-related Kaposi's sarcoma (AIDS-KS) who have failed prior liposomal anthracycline therapy;
• metastatic carcinoma of the breast (MBC) who have failed, or are not candidates for standard anthracycline-containing therapy;
• advanced carcinoma of the ovary (AOC) or with residual disease (> 1 cm) after initial laparotomy, in combination with cisplatin as first-line treatment;
• metastatic carcinoma of the ovary (MOC) after failure of platinum-containing combination therapy without taxanes as second-line treatment;
• non-small cell lung carcinoma (NSCLC) who are not candidates for potentially curative surgery and/or radiation therapy, in combination with cisplatin. Limited efficacy data supports this indication (see section 5.1).

The marketing authorisation for Paxene has been withdrawn at the request of the marketing authorisation holder.

Source: European Medicines Agency

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