Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Aldurazyme   
Auth. number : EU/1/03/253
INN : Laronidase
Orphan status based on designation EU/3/01/022 added on 12/06/2003
Orphan status based on designation EU/3/01/022 removed or expired on 12/06/2013
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: A16AB05 - Laronidase
(See WHO ATC Index)
Indication: Long-term enzyme replacement therapy in patients with a confirmed diagnosis of Mucopolysaccharidosis I to treat the non-neurological manifestations of the disease
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 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
12/06/2003 Centralised - Authorisation EMEA/H/C/477 (2003)1880 of 10/06/2003
30/10/2003 Centralised - Variation EMEA/H/C/477/I/1
31/03/2004 Centralised - Variation EMEA/H/C/477/II/3
03/06/2004 Centralised - Variation EMEA/H/C/477/IB/2
Updated with Decision(2004)2797 of 13/07/2004
07/07/2004 Centralised - Variation EMEA/H/C/477/N/4
Updated with Decision(2004)2797 of 13/07/2004
15/07/2004 Centralised - Variation (2004)2797 of 13/07/2004
17/11/2004 Centralised - Variation EMEA/H/C/477/IB/6
29/11/2004 Centralised - Variation EMEA/H/C/477/IB/7
14/01/2005 Centralised - Annual reassessment EMEA/H/C/477/S/5 (2005)96 of 12/01/2005
24/03/2005 Centralised - Variation EMEA/H/C/477/II/8 (2005)1017 of 22/03/2005
30/06/2005 Centralised - Variation EMEA/H/C/477/II/9
25/11/2005 Centralised - Variation EMEA/H/C/477/II/11
23/01/2006 Centralised - Annual reassessment EMEA/H/C/477/S/10 (2006)125 of 19/01/2006
03/05/2006 Centralised - Variation EMEA/H/C/477/II/13
02/06/2006 Centralised - Variation EMEA/H/C/477/II/12 (2006)2220 of 31/05/2006
07/02/2007 Centralised - Annual reassessment EMEA/H/C/477/S/14 (2007)407 of 05/02/2007
28/02/2007 Centralised - Variation EMEA/H/C/477/II/15
02/05/2007 Centralised - Variation EMEA/H/C/477/II/16
27/09/2007 Centralised - Variation EMEA/H/C/477/II/19
07/11/2007 Centralised - Variation EMEA/H/C/477/II/17 (2007)5427 of 31/10/2007
18/12/2007 Centralised - Variation EMEA/H/C/477/IB/20
24/12/2007 Centralised - Annual reassessment EMEA/H/C/477/S/18 (2007)6804 of 20/12/2007
22/05/2008 Centralised - Renewal EMEA/H/C/477/R/21 (2008)2158 of 20/05/2008
01/10/2008 Centralised - Annual reassessment EMEA/H/C/477/S/22
28/10/2008 Centralised - Variation EMEA/H/C/477/II/23
07/07/2009 Centralised - Variation EMEA/H/C/477/II/24 (2009)5477 of 02/07/2009
30/09/2009 Centralised - Variation EMEA/H/C/477/IA/27
01/10/2009 Centralised - Annual reassessment EMEA/H/C/477/S/25
06/10/2009 Centralised - Variation EMEA/H/C/477/II/26
19/03/2010 Centralised - Variation EMEA/H/C/477/IA/29
29/04/2010 Centralised - Variation EMEA/H/C/477/II/28 (2010)2841 of 27/04/2010
29/06/2010 Centralised - Variation EMEA/H/C/477/II/30
28/09/2010 Centralised - Annual reassessment EMEA/H/C/477/S/31
18/04/2011 Centralised - Variation EMEA/H/C/477/N/35
Updated with Decision(2011)8649 of 21/11/2011
18/04/2011 Centralised - Variation EMEA/H/C/477/IA/34
23/11/2011 Centralised - Annual reassessment EMEA/H/C/477/S/37 (2011)8649 of 21/11/2011
14/05/2012 Centralised - Variation EMEA/H/C/477/N/40
Updated with Decision(2013)1015 of 18/02/2013
20/02/2013 Centralised - Annual reassessment EMEA/H/C/477/S/41 (2013)1015 of 18/02/2013
12/06/2013 Centralised - (orphan status)
23/12/2013 Centralised - Annual reassessment EMEA/H/C/477/S/47 (2013)9752 of 18/12/2013