Paxene (paclitaxel)
- Region
- 🇪🇺 EU
- Active substance
- paclitaxel
- Company
- Norton Healthcare Ltd.
- Status
- Withdrawn
- Therapeutic area
- Sarcoma, Kaposi; Carcinoma, Non-Small-Cell Lung; Ovarian Neoplasms; Breast Neoplasms
- EU approval
- Mon 19 Jul 1999
- Application
- EMEA/H/C/000216
- ATC
- L01CD01
- Official record
- www.ema.europa.eu
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).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
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- 🇪🇺 Naveruclif Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Apexelsin Authorised · Whiteoak Pharmaceutical B.V.
- 🇪🇺 Apealea Withdrawn · Inceptua AB
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.