Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Fabrazyme   
Auth. number : EU/1/01/188
INN : Agalsidase beta
Orphan status based on designation EU/3/00/003 added on 07/08/2001
Orphan status based on designation EU/3/00/003 removed or expired on 07/08/2011
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A16 - Other alimentary tract and metabolism products
Pharmacological subgroup: A16A - Other alimentary tract and metabolism products
Chemical subgroup: A16AB - Enzymes
Chemical substance: A16AB04 - Agalsidase beta
(See WHO ATC Index)
Indication: Fabrazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency).
Fabrazyme is indicated in adults, children and adolescents aged 8 years and older.
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
07/08/2001 Centralised - Authorisation EMEA/H/C/370 (2001)2081 of 03/08/2001
11/03/2002 Centralised - Variation EMEA/H/C/370/I/1 (2002)1018 of 07/03/2002
29/07/2002 Centralised - Variation EMEA/H/C/370/II/3
17/09/2002 Centralised - Variation EMEA/H/C/370/I/2
04/12/2002 Centralised - Variation EMEA/H/C/370/II/4 (2002)4904 of 02/12/2002
28/01/2003 Centralised - Annual reassessment EMEA/H/C/370/S/6 (2003)415 of 24/01/2003
10/04/2003 Centralised - Variation EMEA/H/C/370/II/5 (2003)1244 of 08/04/2003
22/05/2003 Centralised - Variation EMEA/H/C/370/II/7 (2003)1726 of 19/05/2003
24/07/2003 Centralised - Variation EMEA/H/C/370/II/8 (2003)2739 of 22/07/2003
08/08/2003 Centralised - Variation EMEA/H/C/370/I/9 (2003)2939 of 05/08/2003
15/01/2004 Centralised - Variation EMEA/H/C/370/I/11
20/01/2004 Centralised - Annual reassessment EMEA/H/C/370/S/10 (2004)116 of 16/01/2004
12/08/2004 Centralised - Variation EMEA/H/C/370/II/12 (2004)3149 of 09/08/2004
13/10/2004 Centralised - Variation EMEA/H/C/370/IB/13
22/02/2005 Centralised - Variation EMEA/H/C/370/IB/15
07/03/2005 Centralised - Annual reassessment EMEA/H/C/370/S/14 (2005)571 of 03/03/2005
03/08/2005 Centralised - Variation EMEA/H/C/370/II/16 (2005)3047 of 01/08/2005
23/09/2005 Centralised - Variation EMEA/H/C/370/II/17
15/02/2006 Centralised - Annual reassessment EMEA/H/C/370/S/18 (2006)502 of 13/02/2006
02/08/2006 Centralised - Renewal EMEA/H/C/370/R/20 (2006)3529 of 28/07/2006
25/08/2006 Centralised - Variation EMEA/H/C/370/N/21
Updated with Decision(2007)260 of 24/01/2007
07/09/2006 Centralised - Variation EMEA/H/C/370/II/19 (2006)4074 of 01/09/2006
26/01/2007 Centralised - Variation EMEA/H/C/370/II/22/23 (2007)260 of 24/01/2007
19/02/2007 Centralised - Annual reassessment EMEA/H/C/370/S/24 (2007)543 of 15/02/2007
24/10/2007 Centralised - Variation EMEA/H/C/370/II/26
24/10/2007 Centralised - Variation EMEA/H/C/370/II/25 (2007)5248 of 22/10/2007
08/02/2008 Centralised - Annual reassessment EMEA/H/C/370/S/27 (2008)535 of 06/02/2008
05/05/2008 Centralised - Variation EMEA/H/C/370/IB/28
05/05/2008 Centralised - Variation EMEA/H/C/370/IB/29
13/08/2008 Centralised - Variation EMEA/H/C/370/N/30
Updated with Decision(2010)520 of 25/01/2010
16/09/2008 Centralised - Variation EMEA/H/C/370/IB/32
01/10/2008 Centralised - Variation EMEA/H/C/370/II/31
27/02/2009 Centralised - Variation EMEA/H/C/370/II/33
13/05/2009 Centralised - Variation EMEA/H/C/370/IB/34
16/07/2009 Centralised - Variation EMEA/H/C/370/IA/36
16/07/2009 Centralised - Variation EMEA/H/C/370/N/35
Updated with Decision(2010)520 of 25/01/2010
01/10/2009 Centralised - Variation EMEA/H/C/370/II/38
06/10/2009 Centralised - Variation EMEA/H/C/370/II/37
01/12/2009 Centralised - Variation EMEA/H/C/370/IA/40
27/01/2010 Centralised - Variation EMEA/H/C/370/II/39 (2010)520 of 25/01/2010
11/02/2010 Centralised - Variation EMEA/H/C/370/IA/41
28/04/2010 Centralised - Variation EMEA/H/C/370/II/42
25/05/2010 Centralised - Variation EMEA/H/C/370/IA/43
01/07/2010 Centralised - Variation EMEA/H/C/370/IB/44
06/07/2010 Centralised - Variation EMEA/H/C/370/IA/46
06/07/2010 Centralised - Variation EMEA/H/C/370/IA/45
Updated with Decision(2011)1500 of 28/02/2011
04/03/2011 Centralised - Variation (2011)1500 of 28/02/2011
30/03/2011 Centralised - Variation EMEA/H/C/370/II/47/G
09/06/2011 Centralised - Variation EMEA/H/C/370/II/48 (2011)4174 of 07/06/2011
07/08/2011 Centralised - (orphan status)
24/11/2011 Centralised - Variation EMEA/H/C/370/II/49 (2011)8740 of 22/11/2011
25/11/2011 Centralised - Variation EMEA/H/C/370/II/49 (2011)8741 of 22/11/2011
18/04/2012 Centralised - Variation EMEA/H/C/370/N/55
Updated with Decision(2014)5380 of 23/07/2014
23/07/2012 Centralised - Variation EMEA/H/C/370/N/57
Updated with Decision(2014)5380 of 23/07/2014
25/07/2013 Centralised - Variation EMEA/H/C/370/IA/67
Updated with Decision(2014)5380 of 23/07/2014
07/11/2013 Centralised - Variation EMEA/H/C/370/N/69
Updated with Decision(2014)5380 of 23/07/2014
26/06/2014 Centralised - Variation EMEA/H/C/370/II/74/G
24/07/2014 Centralised - Variation (2014)5380 of 23/07/2014