Apexelsin (paclitaxel)
- Region
- 🇪🇺 EU
- Active substance
- paclitaxel
- Company
- Whiteoak Pharmaceutical B.V.
- Status
- Authorised
- Therapeutic area
- Breast Neoplasms; Pancreatic Neoplasms; Carcinoma, Non-Small-Cell Lung
- CHMP opinion
- Thu 30 May 2024
- EU approval
- Wed 24 Jul 2024
- Designations
- Generic, Additional monitoring
- Application
- EMEA/H/C/005997
- ATC
- L01CD01
- Official record
- www.ema.europa.eu
Indication
Apexelsin monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated. Apexelsin in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas. Apexelsin in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Pazenir Authorised · ratiopharm GmbH
- 🇪🇺 Abraxane Authorised · Bristol-Myers Squibb Pharma EEIG
- 🇪🇺 Naveruclif Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Apealea Withdrawn · Inceptua AB
- 🇪🇺 Paxene Withdrawn · Norton Healthcare Ltd.
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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.