Basic Information
Halaven
Regulatory Information
EMEA/H/C/002084
March 17, 2011
31
October 11, 2024
Company Information
Germany
Eisai GmbH Edmund-Rumpler-Strasse 3 60549 Frankfurt am Main
Eisai GmbH
Active Substances Detail
EMA Resources
Detailed Information
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).
Overview Summary
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.