Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Naglazyme   
Auth. number : EU/1/05/324
INN : galsulfase
Orphan status based on designation EU/3/01/025 added on 26/01/2006
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: A16AB08 - Galsulfase
(See WHO ATC Index)
Indication: Naglazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Mucopolysaccharidosis VI (MPS VI; N-acetylgalactosamine 4-sulfatase deficiency; Maroteaux-Lamy syndrome) (see section 5.1).

A key issue is to treat children aged <5 years suffering from a severe form of the disease, even though children <5 years were not included in the pivotal phase 3 study. Limited data are available in patients < 1 year of age (see section 5.1).
Marketing Authorisation Holder: BioMarin Europe Ltd
164 Shaftesbury Avenue, London WC2H 8HL, 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
26/01/2006 Centralised - Authorisation EMEA/H/C/640 (2006)198 of 24/01/2006
04/04/2006 Centralised - Variation EMEA/H/C/640/IA/2
Updated with Decision(2006)6449 of 04/12/2006
24/04/2006 Centralised - Variation EMEA/H/C/640/IB/3
Updated with Decision(2006)6449 of 04/12/2006
03/05/2006 Centralised - Variation EMEA/H/C/640/II/1
07/07/2006 Centralised - Variation EMEA/H/C/640/N/4
Updated with Decision(2006)6449 of 04/12/2006
19/09/2006 Centralised - Variation EMEA/H/C/640/IB/6
Updated with Decision(2006)6449 of 04/12/2006
23/10/2006 Centralised - Variation EMEA/H/C/640/II/7
06/12/2006 Centralised - Variation (2006)6449 of 04/12/2006
29/01/2007 Centralised - Variation EMEA/H/C/640/II/9
26/02/2007 Centralised - Variation EMEA/H/C/640/II/10
05/07/2007 Centralised - Variation EMEA/H/C/640/IB/12
Updated with Decision(2008)452 of 31/01/2008
05/07/2007 Centralised - Annual reassessment EMEA/H/C/640/S/11 (2007)3309 of 02/07/2007
01/10/2007 Centralised - Variation EMEA/H/C/640/II/13
05/10/2007 Centralised - Variation EMEA/H/C/640/IA/14
Updated with Decision(2008)452 of 31/01/2008
04/02/2008 Centralised - Variation (2008)452 of 31/01/2008
23/04/2008 Centralised - Variation EMEA/H/C/640/IB/16
Updated with Decision(2008)4171 of 29/07/2008
11/06/2008 Centralised - Variation EMEA/H/C/640/II/17
15/07/2008 Centralised - Variation EMEA/H/C/640/II/18
31/07/2008 Centralised - Annual reassessment EMEA/H/C/640/S/15 (2008)4171 of 29/07/2008
11/08/2008 Centralised - Variation EMEA/H/C/640/IA/19
17/02/2009 Centralised - Variation EMEA/H/C/640/IA/20
Updated with Decision(2009)5407 of 01/07/2009
20/05/2009 Centralised - Variation EMEA/H/C/640/IB/24
23/06/2009 Centralised - Variation EMEA/H/C/640/IB/23
03/07/2009 Centralised - Annual reassessment EMEA/H/C/640/S/20 (2009)5407 of 01/07/2009
05/10/2009 Centralised - Variation EMEA/H/C/640/II/25
10/08/2010 Centralised - Annual reassessment EMEA/H/C/640/S/26 (2010)5592 of 06/08/2010
30/09/2010 Centralised - Variation EMEA/H/C/640/II/27
22/12/2010 Centralised - Variation EMEA/H/C/640/II/31 (2010)9609 of 20/12/2010
27/01/2011 Centralised - Renewal EMEA/H/C/640/R/28 (2011)530 of 26/01/2011
24/10/2011 Centralised - Variation EMEA/H/C/640/II/30 (2011)7671 of 20/10/2011
19/11/2012 Centralised - Annual reassessment EMEA/H/C/640/S/34 (2012)8487 of 15/11/2012
21/11/2013 Centralised - Annual reassessment EMEA/H/C/640/S/43
19/12/2013 Centralised - Variation EMEA/H/C/640/IB/47/G
08/01/2014 Centralised - Variation EMEA/H/C/640/IAIN/49
09/07/2014 Centralised - Variation EMEA/H/C/640/IG/458