Paxene
paclitaxel
Table of contents
Overview
The marketing authorisation for Paxene has been withdrawn at the request of the marketing authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
Paxene
|
| Agency product number |
EMEA/H/C/000216
|
| Active substance |
paclitaxel
|
| International non-proprietary name (INN) or common name |
paclitaxel
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
L01CD01
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Norton Healthcare Ltd.
|
| Revision |
14
|
| Date of issue of marketing authorisation valid throughout the European Union |
19/07/1999
|
| 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
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).
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).