Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Zavesca   
Auth. number : EU/1/02/238
Active substance : Miglustat
Orphan market exclusivity for "Treatment of Gaucher Disease" (based on designation EU/3/00/006) started on 21/11/2002
   10 years of market exclusivity
   This orphan market exclusivity has ended on 21/11/2012
Orphan market exclusivity for "Treatment of Niemann-Pick disease, type C" (based on designation EU/3/06/351) started on 28/01/2009
   10 years of market exclusivity
   This orphan market exclusivity will expire on 28/01/2019
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: A16AX - Various alimentary tract and metabolism products
Chemical substance: A16AX06 - Miglustat
(See WHO ATC Index)
Indication: Zavesca is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease. Zavesca may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable.
Zavesca is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type C disease.
Marketing Authorisation Holder: Actelion Registration Ltd
Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, 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
21/11/2002 Centralised - Authorisation EMEA/H/C/435 (2002)4579 of 20/11/2002
05/02/2003 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/435/T/1 (2003)480 of 03/02/2003
22/04/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/435/I/2
10/10/2003 Centralised - Variation EMEA/H/C/435/I/3 (2003)3724 of 08/10/2003
23/08/2004 Centralised - Annual reassessment EMEA/H/C/435/S/4 (2004)3264 of 18/08/2004
15/10/2004 Centralised - Variation EMEA/H/C/435/IA/9
Updated with Decision(2005)1733 of 03/06/2005
15/10/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/435/IA/5
08/11/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/435/IB/7
08/12/2004 Centralised - Variation EMEA/H/C/435/IB/8
Updated with Decision(2005)1733 of 03/06/2005
08/12/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/435/IB/6
11/01/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/435/IB/10
07/06/2005 Centralised - Annual reassessment EMEA/H/C/435/II/S/11 (2005)1733 of 03/06/2005
26/09/2005 Centralised - Notification EMEA/H/C/435/N/12
Updated with Decision(2006)1741 of 24/04/2006
16/11/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/435/IA/14
16/11/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/435/IB/13
26/04/2006 Centralised - Annual reassessment EMEA/H/C/435/S/15 (2006)1741 of 24/04/2006
25/07/2006 Centralised - Variation EMEA/H/C/435/IA/17
Updated with Decision(2007)606 of 20/02/2007
25/07/2006 Centralised - Variation EMEA/H/C/435/IA/18
Updated with Decision(2007)606 of 20/02/2007
27/09/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/435/II/16
12/10/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/435/IA/20
22/02/2007 Centralised - Variation (2007)606 of 20/02/2007
02/03/2007 Centralised - Variation EMEA/H/C/435/II/19 (2007)748 of 28/02/2007
25/05/2007 Centralised - Annual reassessment EMEA/H/C/435/S/23 (2007)2258 of 22/05/2007
11/09/2007 Centralised - Renewal EMEA/H/C/435/R/24 (2007)4254 of 07/09/2007
19/12/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/435/II/25
20/03/2008 Centralised - Variation EMEA/H/C/435/II/26 (2008)1176 of 18/03/2008
22/05/2008 Centralised - Annual reassessment EMEA/H/C/435/S/27 (2008)2027 of 20/05/2008
30/10/2008 Centralised - Variation EMEA/H/C/435/II/28 (2008)6487 of 28/10/2008
28/01/2009 Centralised - Variation EMEA/H/C/435/II/29 (2009)555 of 26/01/2009
28/05/2009 Centralised - Annual reassessment EMEA/H/C/435/S/30 (2009)4217 of 26/05/2009
17/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/435/IB/31
04/06/2010 Centralised - Annual reassessment EMEA/H/C/435/S/32 (2010)3645 of 02/06/2010
18/05/2011 Centralised - Annual reassessment EMEA/H/C/435/S/33 (2011)3534 of 16/05/2011
28/12/2011 Centralised - Variation EMEA/H/C/435/II/34 (2011)10102 of 22/12/2011
27/08/2012 Centralised - Annual reassessment EMEA/H/C/435/S/36 (2012)5997 of 23/08/2012
04/10/2012 Centralised - Variation EMEA/H/C/435/IA/38/G
Updated with Decision(2013)5444 of 12/08/2013
10/10/2012 Centralised - Renewal EMEA/H/C/435/R/37 (2012)7153 of 08/10/2012
21/11/2012 Centralised - (orphan status)
01/02/2013 Centralised - Variation EMEA/H/C/435/IB/40/G
Updated with Decision(2013)5444 of 12/08/2013
04/07/2013 Centralised - Notification EMEA/H/C/435/N/42
Updated with Decision(2014)8176 of 27/10/2014
14/08/2013 PSUSA - Modification EMEA/H/C/435/PSU/45 (2013)5444 of 12/08/2013
12/11/2013 Centralised - Variation EMEA/H/C/435/IB/43
Updated with Decision(2014)8176 of 27/10/2014
07/04/2014 Centralised - Notification EMEA/H/C/435/N/45
Updated with Decision(2014)8176 of 27/10/2014
29/10/2014 Centralised - Yearly update (2014)8176 of 27/10/2014
07/09/2015 Centralised - Variation EMEA/H/C/435/IG/612
Updated with Decision(2016)5268 of 08/08/2016
12/10/2015 Centralised - Notification EMEA/H/C/435/N/51
Updated with Decision(2016)5268 of 08/08/2016
10/08/2016 Centralised - Yearly update (2016)5268 of 08/08/2016
16/08/2016 Centralised - Variation EMEA/H/C/435/IG/0720
Updated with Decision(2017)5256 of 19/07/2017