Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Cerezyme   
Auth. number : EU/1/97/053
INN : imiglucerase
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: A16AB02 - Imiglucerase
(See WHO ATC Index)
Indication: Cerezyme (imiglucerase) is indicated for use as long-term enzyme replacement therapy in patients with a confirmed diagnosis of non-neuronopathic (Type 1) or chronic neuronopathic (Type 3) Gaucher disease who exhibit clinically significant non-neurological manifestations of the disease.The non-neurological manifestations of Gaucher disease include one or more of the following conditions:- anaemia after exclusion of other causes, such as iron deficiency- thrombocytopenia- bone disease after exclusion of other causes such as Vitamin D deficiency- hepatomegaly or splenomegaly
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
18/11/1997 Centralised - Authorisation EMEA/H/C/157 (97)3539 of 17/11/1997
19/05/1998 Centralised - Variation EMEA/H/C/157/N/6 (1998)1352 of 18/05/1998
30/06/1999 Centralised - Variation EMEA/H/C/157/II/8 (1999)1648 of 18/06/1999
16/11/1999 Centralised - Variation EMEA/H/C/157/II/1 (1999)3789 of 16/11/1999
02/02/2000 Centralised - Authorisation EMEA/H/C/157/X/10 (2000)121 of 28/01/2000
06/04/2001 Centralised - Variation EMEA/H/C/157/I/13
02/04/2002 Centralised - Variation EMEA/H/C/157/I/16 (2002)1321 of 26/03/2002
12/04/2002 Centralised - Variation EMEA/H/C/157/I/15
13/12/2002 Centralised - Renewal EMEA/H/C/157/R/17 (2002)5156 of 11/12/2002
18/07/2003 Centralised - Variation EMEA/H/C/157/I/21
01/09/2003 Centralised - Variation EMEA/H/C/157/II/18 (2003)3179 of 28/08/2003
30/03/2004 Centralised - Variation EMEA/H/C/157/IA/22
16/04/2004 Centralised - Variation EMEA/H/C/157/IB/24
01/05/2004 Centralised - Variation EMEA/H/C/157/N/25
07/06/2004 Centralised - Variation EMEA/H/C/157/IA/26
11/06/2004 Centralised - Variation EMEA/H/C/157/II/23
25/10/2004 Centralised - Variation EMEA/H/C/157/II/27
22/02/2005 Centralised - Variation EMEA/H/C/157/II/28
03/03/2005 Centralised - Variation EMEA/H/C/157/IB/30
13/04/2005 Centralised - Variation EMEA/H/C/157/II/29 (2005)1186 of 11/04/2005
29/09/2005 Centralised - Variation EMEA/H/C/157/II/31
22/11/2005 Centralised - Variation EMEA/H/C/157/II/33
21/12/2005 Centralised - Variation EMEA/H/C/157/N/34
Updated with Decision(2007)1639 of 04/04/2007
11/04/2006 Centralised - Variation EMEA/H/C/157/IB/35
07/08/2006 Centralised - Variation EMEA/H/C/157/II/36
01/03/2007 Centralised - Variation EMEA/H/C/157/II/38
11/04/2007 Centralised - Variation EMEA/H/C/157/II/37 (2007)1639 of 04/04/2007
14/06/2007 Centralised - Variation EMEA/H/C/157/IB/41
20/09/2007 Centralised - Renewal EMEA/H/C/157/R/39 (2007)4372 of 17/09/2007
25/09/2007 Centralised - Variation EMEA/H/C/157/II/40
19/05/2008 Centralised - Variation EMEA/H/C/157/IB/44
19/05/2008 Centralised - Variation EMEA/H/C/157/IB/43
05/06/2008 Centralised - Variation EMEA/H/C/157/II/42
24/12/2008 Centralised - Variation EMEA/H/C/157/II/45 (2008)8977 of 22/12/2008
11/05/2009 Centralised - Variation EMEA/H/C/157/IB/47
02/07/2009 Centralised - Variation EMEA/H/C/157/II/46 (2009)5394 of 30/06/2009
15/07/2009 Centralised - Variation EMEA/H/C/157/IA/48
29/09/2009 Centralised - Variation EMEA/H/C/157/II/50
24/11/2009 Centralised - Variation EMEA/H/C/157/IA/53
25/11/2009 Centralised - Variation EMEA/H/C/157/II/49
15/03/2010 Centralised - Variation EMEA/H/C/157/IA/54
22/06/2010 Centralised - Variation EMEA/H/C/157/IB/56
Updated with Decision(2010)6009 of 26/08/2010
22/06/2010 Centralised - Variation EMEA/H/C/157/IA/60
12/07/2010 Centralised - Variation EMEA/H/C/157/IB/59
27/07/2010 Centralised - Variation EMEA/H/C/157/II/55
30/08/2010 Centralised - Variation EMEA/H/C/157/II/58 (2010)6009 of 26/08/2010
27/10/2010 Centralised - Variation EMEA/H/C/157/II/57 (2010) 7551 of 25/10/2010
17/05/2011 Centralised - Variation EMEA/H/C/157/N/61
Updated with Decision(2012)486 of 24/01/2012
30/05/2011 Centralised - Variation EMEA/H/C/157/IA/62
Updated with Decision(2012)486 of 24/01/2012
26/01/2012 Centralised - Variation (2012)486 of 24/01/2012
13/04/2012 Centralised - Variation EMEA/H/C/157/N/65
19/07/2012 Centralised - Variation EMEA/H/C/157/N/66
07/11/2013 Centralised - Variation EMEA/H/C/157/N/76