Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Myozyme   
Auth. number : EU/1/06/333
INN : alglucosidase alfa
Orphan status based on designation EU/3/00/018 added on 31/03/2006
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: A16AB07 - Alglucosidase alfa
(See WHO ATC Index)
Indication: Myozyme is indicated for long-term enzyme replacement therapy (ERT) in patients with a confirmed diagnosis of Pompe disease (acid α-glucosidase deficiency).
Myozyme is indicated in adults and paediatric patients of all ages.
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
31/03/2006 Centralised - Authorisation EMEA/H/C/636 (2006)1356 of 29/03/2006
02/08/2006 Centralised - Variation EMEA/H/C/636/II/1 (2006)3530 of 28/07/2006
01/08/2007 Centralised - Variation EMEA/H/C/636/II/3
12/10/2007 Centralised - Variation EMEA/H/C/636/II/2 (2007)5062 of 09/10/2007
16/11/2007 Centralised - Variation EMEA/H/C/636/IB/4
15/07/2008 Centralised - Variation EMEA/H/C/636/II/6
20/10/2008 Centralised - Variation EMEA/H/C/636/IA/9
Updated with Decision(2009)1290 of 20/02/2009
04/11/2008 Centralised - Variation EMEA/H/C/636/II/5 (2008)6600 of 30/10/2008
28/11/2008 Centralised - Variation EMEA/H/C/636/II/8
09/02/2009 Centralised - Variation EMEA/H/C/636/IB/11
Updated with Decision(2009)1334 of 23/02/2009
24/02/2009 Centralised - Variation EMEA/H/C/636/II/10 (2009)1290 of 20/02/2009
25/02/2009 Centralised - Variation EMEA/H/C/636/II/12 (2009)1334 of 23/02/2009
24/04/2009 Corrigendum EMEA/H/C/636
15/05/2009 Centralised - Variation EMEA/H/C/636/IB/15
01/07/2009 Centralised - Variation EMEA/H/C/636/II/14
29/07/2009 Centralised - Variation EMEA/H/C/636/II/16
25/08/2009 Centralised - Variation EMEA/H/C/636/II/13 (2009)6627 of 21/08/2009
04/09/2009 Centralised - Variation EMEA/H/C/636/IA/17
02/11/2009 Centralised - Variation EMEA/H/C/636/II/7 (2009)8512 of 28/10/2009
07/01/2010 Centralised - Variation EMEA/H/C/636/IA/18
10/05/2010 Centralised - Variation EMEA/H/C/636/IA/19
Updated with Decision(2010)6022 of 26/08/2010
14/06/2010 Centralised - Variation EMEA/H/C/636/IB/21
14/06/2010 Centralised - Variation EMEA/H/C/636/IA/20/G
Updated with Decision(2010)6022 of 26/08/2010
31/08/2010 Centralised - Variation (2010)6022 of 26/08/2010
07/09/2010 Centralised - Variation EMEA/H/C/636/IB/23
Updated with Decision(2011)1218 of 21/02/2011
16/09/2010 Centralised - Variation EMEA/H/C/636/IA/25
30/09/2010 Centralised - Variation EMEA/H/C/636/II/22
28/02/2011 Centralised - Renewal EMEA/H/C/636/R/24 (2011)1218 of 21/02/2011
24/11/2011 Centralised - Variation EMEA/H/C/636/II/27 (2011)8680 of 22/11/2011
19/07/2012 Centralised - Variation EMEA/H/C/636/N/38
Updated with Decision(2013)9746 of 18/12/2013
20/12/2012 Centralised - Variation EMEA/H/C/636/IB/40
Updated with Decision(2013)9746 of 18/12/2013
23/12/2013 Centralised - Variation EMEA/H/C/636/II/41, 46 (2013)9746 of 18/12/2013