Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: HALAVEN   
Auth. number : EU/1/11/678
Active substance : eribulin
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01XX - Other antineoplastic agents
Chemical substance: L01XX41 - eribulin
(See WHO ATC Index)
Indication: HALAVEN 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 (see section 5.1). 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.

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
Marketing Authorisation Holder: Eisai Europe Limited
European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
22/03/2011 Centralised - Authorisation EMEA/H/C/2084 (2011)1887 of 17/03/2011
15/07/2011 Corrigendum (2011)1887 of 13/07/2011
25/04/2012 Centralised - Variation EMEA/H/C/2084/II/4 (2012)2839 of 20/04/2012
25/05/2012 Centralised - Variation EMEA/H/C/2084/II/5 (2012)3452 of 22/05/2012
15/11/2012 Centralised - Variation EMEA/H/C/2084/II/6
Updated with Decision(2013)8338 of 20/11/2013
25/04/2013 Centralised - Variation EMEA/H/C/2084/II/9
Updated with Decision(2013)8338 of 20/11/2013
07/08/2013 Centralised - Notification EMEA/H/C/2084/N/12
Updated with Decision(2013)8338 of 20/11/2013
25/11/2013 Centralised - Yearly update (2013)8338 of 20/11/2013
18/12/2013 Centralised - Variation EMEA/H/C/2084/II/14
Updated with Decision(2014)4505 of 27/06/2014
01/07/2014 Centralised - 2-Monthly update EMEA/H/C/2084/II/11 (2014)4505 of 27/06/2014
26/02/2015 Centralised - Variation EMEA/H/C/2084/II/21
Updated with Decision(2015)5141 of 17/07/2015
13/04/2015 Centralised - Variation EMEA/H/C/2084/IB/25
Updated with Decision(2015)5141 of 17/07/2015
25/06/2015 Centralised - Variation EMEA/H/C/2084/II/23
Updated with Decision(2015)8296 of 19/11/2015
21/07/2015 PSUSA - Modification EMEA/H/C/2084/PSUSA/1254/201411 (2015)5141 of 17/07/2015
23/11/2015 Centralised - Renewal EMEA/H/C/2084/R/27 (2015)8296 of 19/11/2015
18/02/2016 Centralised - Variation EMEA/H/C/2084/II/29/G
Updated with Decision(2016)2823 of 02/05/2016
04/05/2016 Centralised - 2-Monthly update EMEA/H/C/2084/II/28 (2016)2823 of 02/05/2016
18/08/2016 PSUSA - Modification EMEA/H/C/2084/PSUSA/1254/201511 (2016)5402 of 16/08/2016
17/08/2017 Centralised - Variation EMEA/H/C/2084/IB/40
16/11/2017 Centralised - Notification EMEA/H/C/2084/N/42