Halaven (eribulin)
- Region
- 🇪🇺 EU
- Active substance
- eribulin
- Company
- Eisai GmbH
- Status
- Authorised
- Therapeutic area
- Breast Neoplasms; Liposarcoma
- EU approval
- Thu 17 Mar 2011
- Application
- EMEA/H/C/002084
- ATC
- L01XX41
- Official record
- www.ema.europa.eu
Indication
Halaven monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimens for advanced disease (see section 5.1). Prior therapy should have included an anthracycline and a taxane unless patients were not suitable for these treatments. Halaven 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 (see section 5.1).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Eribulin Baxter Authorised · Baxter Holding B.V.
- 🇪🇺 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.