This is a summary of the European public assessment report (EPAR) for Halaven. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Halaven.
Therapeutic Indication
### Therapeutic 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).
Therapeutic Area (MeSH)
N/AATC Code
L01XX41
ATC Item
eribulin
Pharmacotherapeutic Group
Antineoplastic agents
Active Substance (Summary)
INN / Common Names
N/A| Substance | CAS | Monograph |
|---|---|---|
| Eribulin | N/A | 艾立布林 |
EMA Name
Halaven
Medicine Name
Halaven
Aliases
N/ANo risk management plan link.
