This medicine is now withdrawn from use in the European Union.


The marketing authorisation for Paxene has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 22/03/2010

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Sarcoma, Kaposi
  • Carcinoma, Non-Small-Cell Lung
  • Ovarian Neoplasms
  • Breast Neoplasms
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Norton Healthcare Ltd.
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Norton Healthcare Limited
Albert Basin
Royal Docks
London E16 2QJ
United Kingdom

Product information

14/07/2009 Paxene - EMEA/H/C/000216 - R/0047

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Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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).

Assessment history

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