Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Mozobil   
Auth. number : EU/1/09/537
Active substance : Plerixafor
Orphan market exclusivity for "Treatment to mobilize progenitor cells prior to stem cell transplantation" (based on designation EU/3/04/227) started on 04/08/2009
   10 years of market exclusivity
   This orphan market exclusivity will expire on 04/08/2019
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L03 - Immunomodulating agents
Pharmacological subgroup: L03A - Immunostimulating agents
Chemical subgroup: L03AX - Other immunostimulating agents
Chemical substance: L03AX16 - Plerixafor
(See WHO ATC Index)
Indication: Mozobil is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in adult patients with lymphoma and multiple myeloma whose cells mobilise poorly.
Marketing Authorisation Holder: Genzyme Europe B.V.
Gooimeer 10, NL-1411 DD Naarden, Nederland
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
04/08/2009 Centralised - Authorisation EMEA/H/C/1030 (2009)6238 of 31/07/2009
13/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1030/IA/2
19/03/2010 Centralised - Variation EMEA/H/C/1030/II/1 (2010)1822 of 15/03/2010
21/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1030/IA/3/G
22/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1030/IB/4
01/04/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1030/IA/5
07/06/2011 Centralised - Notification EMEA/H/C/1030/N/6
Updated with Decision(2012)3643 of 25/05/2012
10/11/2011 Centralised - Variation EMEA/H/C/1030/IG/116
Updated with Decision(2012)3643 of 25/05/2012
25/04/2012 Centralised - Notification EMEA/H/C/1030/N/10
Updated with Decision(2014)1000 of 12/02/2014
01/06/2012 Centralised - Variation (2012)3643 of 25/05/2012
11/07/2012 Centralised - Notification EMEA/H/C/1030/N/12
Updated with Decision(2014)1000 of 12/02/2014
21/02/2013 Centralised - Variation EMEA/H/C/1030/II/14
Updated with Decision(2014)1000 of 12/02/2014
15/08/2013 Centralised - Notification EMEA/H/C/1030/N/16
Updated with Decision(2014)1000 of 12/02/2014
13/02/2014 Centralised - Yearly update (2014)1000 of 12/02/2014
15/04/2014 Centralised - Renewal EMEA/H/C/1030/R/19 (2014)2645 of 11/04/2014
24/09/2014 PSUSA - Modification EMEA/H/C/1030/PSUV/21 (2014)6861 of 22/09/2014
24/03/2015 Centralised - Variation EMEA/H/C/1030/IB/23
Updated with Decision(2016)1442 of 02/03/2016
14/07/2015 Centralised - Notification EMEA/H/C/1030/N/25
Updated with Decision(2016)1442 of 02/03/2016
04/03/2016 Centralised - Yearly update (2016)1442 of 02/03/2016
22/06/2017 Centralised - Variation EMEA/H/C/1030/II/30/G