Paxene

Withdrawn

This medicine's authorisation has been withdrawn

paclitaxel

Overview

The marketing authorisation for Paxene has been withdrawn at the request of the marketing authorisation holder.

Paxene : EPAR - Summary for the public

Product information

Paxene : EPAR - Product Information

Latest procedure affecting product information: R/0047

14/07/2009

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

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).

Paxene : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Paxene
• Active substance:
  paclitaxel
• International non-proprietary name (INN) or common name:
  paclitaxel
• Therapeutic area (MeSH):
  • Sarcoma, Kaposi
  • Carcinoma, Non-Small-Cell Lung
  • Ovarian Neoplasms
  • Breast Neoplasms
• Anatomical therapeutic chemical (ATC) code:
  L01CD01

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).

Authorisation details

• EMA product number:
  EMEA/H/C/000216
• Marketing authorisation holder:
  Norton Healthcare Ltd.

  Norton Healthcare Limited; Albert Basin; Royal Docks; London E16 2QJ; United Kingdom

• Marketing authorisation issued:
  19/07/1999
• Revision:
  14

Assessment history

Changes since initial authorisation of medicine

Paxene : EPAR - Procedural steps taken and scientific information after authorisation

Paxene-H-C-399-II-26 : EPAR - Scientific Discussion - Variation

Adopted

Paxene : EPAR - Steps taken after authorisation when a cutoff date has been used

Paxene-H-C-399-II-25 : EPAR - Scientific Discussion - Variation

Adopted

Initial marketing authorisation documents

Paxene : EPAR - Procedural steps taken before authorisation

Paxene : EPAR - Scientific Discussion