Eribulin Baxter (eribulin)
- Region
- 🇪🇺 EU
- Active substance
- eribulin
- Company
- Baxter Holding B.V.
- Status
- Authorised
- Therapeutic area
- Breast Neoplasms; Liposarcoma
- CHMP opinion
- Thu 25 Apr 2024
- EU approval
- Thu 27 Jun 2024
- Designations
- Generic
- Application
- EMEA/H/C/006191
- ATC
- L01XX41
- Official record
- www.ema.europa.eu
Indication
Eribulin Baxter is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments. Eribulin Baxter is indicated for the treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Halaven Authorised · Eisai GmbH
- 🇪🇺 Mevlyq Authorised · YES Pharmaceutical Development Services GmbH
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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.