Halaven

RSS

eribulin

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 08/11/2018

Authorisation details

Product details
Name
Halaven
Agency product number
EMEA/H/C/002084
Active substance
Eribulin
International non-proprietary name (INN) or common name
eribulin
Therapeutic area (MeSH)
  • Breast Neoplasms
  • Liposarcoma
Anatomical therapeutic chemical (ATC) code
L01XX41
Publication details
Marketing-authorisation holder
Eisai GmbH
Revision
17
Date of issue of marketing authorisation valid throughout the European Union
16/03/2011

Product information

27/09/2018 Halaven - EMEA/H/C/002084 - T/0046

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antineoplastic agents

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).

Assessment history

Changes since initial authorisation of medicine

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