Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: HALAVEN   
Auth. number : EU/1/11/678
INN : eribulin
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01X - Other cytostatics
Chemical subgroup: L01XX - Other antineoplastic agents
Chemical substance: L01XX41 - Eribulin
(See WHO ATC Index)
Indication: for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease
Marketing Authorisation Holder: Eisai Europe Limited
European Knowledge Centre, Mosquito Way, Hatfield, Herts 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 continues to be 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 - Variation EMEA/H/C/2084/N/12
Updated with Decision(2013)8338 of 20/11/2013
25/11/2013 Centralised - Variation (2013)8338 of 20/11/2013
18/12/2013 Centralised - Variation EMEA/H/C/2084/II/14