The marketing authorisation for Paxene has been withdrawn at the request of the marketing authorisation holder.
Paxene : EPAR - Summary for the public (PDF/265.36 KB)
First published: 13/08/2009
Last updated: 22/03/2010
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Norton Healthcare Ltd.
|Date of issue of marketing authorisation valid throughout the European Union||
Norton Healthcare Limited
London E16 2QJ
14/07/2009 Paxene - EMEA/H/C/000216 - R/0047
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Product information documents contain:
- summary of product characteristics (annex I);
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- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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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).