Paxene
Withdrawn
This medicine's authorisation has been withdrawn
paclitaxel
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 19 July 1999 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Paxene.
The marketing authorisation holder (MAH) responsible for Paxene was Norton Healthcare Limited. The European Commission was notified by letter dated 26 October 2009 of the MAH’s decision to voluntarily withdraw the marketing authorisation as of 1 March 2010 for Paxene for commercial reasons. Paxene was only marketed in France.
On 26 November 2009 the European Commission issued a decision to withdraw the marketing authorisation for Paxene.
Pursuant to this decision the European Public Assessment Report for Paxene is updated to reflect that the marketing authorisation is no longer valid.
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).
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 agentsTherapeutic 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).
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