Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Zonegran   
Auth. number : EU/1/04/307
INN : zonisamide
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N03 - Antiepileptics
Pharmacological subgroup: N03A - Antiepileptics
Chemical subgroup: N03AX - Other antiepileptics
Chemical substance: N03AX15 - Zonisamide
(See WHO ATC Index)
Indication: Zonegran is indicated as:
monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy;
adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents, and children aged 6 years and above.
Marketing Authorisation Holder: Eisai Limited
European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, 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
14/03/2005 Centralised - Authorisation EMEA/H/C/577 (2005)811 of 10/03/2005
18/04/2005 Centralised - Variation EMEA/H/C/577/IA/3
Updated with Decision(2006)78 of 13/01/2006
18/04/2005 Centralised - Variation EMEA/H/C/577/IA/1
Updated with Decision(2006)78 of 13/01/2006
18/04/2005 Centralised - Variation EMEA/H/C/577/IA/2
02/05/2005 Centralised - Variation EMEA/H/C/577/IB/6
Updated with Decision(2006)78 of 13/01/2006
02/05/2005 Centralised - Variation EMEA/H/C/577/IB/8
Updated with Decision(2006)78 of 13/01/2006
02/05/2005 Centralised - Variation EMEA/H/C/577/IB/7
Updated with Decision(2006)78 of 13/01/2006
02/05/2005 Centralised - Variation EMEA/H/C/577/IB/5
Updated with Decision(2006)78 of 13/01/2006
02/05/2005 Centralised - Variation EMEA/H/C/577/IB/4
Updated with Decision(2006)78 of 13/01/2006
13/06/2005 Centralised - Variation EMEA/H/C/577/IA/9
04/08/2005 Centralised - Variation EMEA/H/C/577/IA/10
22/09/2005 Centralised - Variation EMEA/H/C/577/IA/11
12/01/2006 Centralised - Variation EMEA/H/C/577/IA/12
17/01/2006 Centralised - Variation (2006)78 of 13/01/2006
15/02/2006 Centralised - Variation EMEA/H/C/577/N/13
Updated with Decision(2006)4130 of 07/09/2006
05/04/2006 Centralised - Variation EMEA/H/C/577/IB/14
Updated with Decision(2006)4130 of 07/09/2006
03/08/2006 Centralised - Variation EMEA/H/C/577/II/15
12/09/2006 Centralised - Variation EMEA/H/C/577/II/16 (2006)4130 of 07/09/2006
24/11/2006 Centralised - Variation EMEA/H/C/577/IA/18
Updated with Decision(2007)1517 of 28/03/2007
15/01/2007 Centralised - Variation EMEA/H/C/577/IB/20
Updated with Decision(2007)1517 of 28/03/2007
15/01/2007 Centralised - Variation EMEA/H/C/577/IB/19
Updated with Decision(2007)1517 of 28/03/2007
30/03/2007 Centralised - Variation EMEA/H/C/577/II/21 (2007)1517 of 28/03/2007
24/04/2007 Centralised - Variation EMEA/H/C/577/IB/22
22/06/2007 Centralised - Variation EMEA/H/C/577/IA/24
05/09/2007 Centralised - Variation EMEA/H/C/577/IA/28
18/09/2007 Centralised - Variation EMEA/H/C/577/N/27
Updated with Decision(2007)5367 of 29/10/2007
31/10/2007 Centralised - Variation EMEA/H/C/577/II/25, 26 (2007)5367 of 29/10/2007
14/12/2007 Centralised - Variation EMEA/H/C/577/IB/30
20/12/2007 Centralised - Variation EMEA/H/C/577/II/29 (2007)6759 of 18/12/2007
15/02/2008 Centralised - Variation EMEA/H/C/577/IA/33
18/02/2008 Centralised - Variation EMEA/H/C/577/IA/32
Updated with Decision(2008)1281 of 31/03/2008
20/02/2008 Centralised - Variation EMEA/H/C/577/IA/34
28/03/2008 Centralised - Variation EMEA/H/C/577/IA/36
28/03/2008 Centralised - Variation EMEA/H/C/577/IA/37
02/04/2008 Centralised - Variation EMEA/H/C/577/II/31 (2008)1281 of 31/03/2008
17/06/2008 Centralised - Variation EMEA/H/C/577/IA/38
02/09/2008 Centralised - Variation EMEA/H/C/577/IA/39
28/11/2008 Centralised - Variation EMEA/H/C/577/IA/42
13/02/2009 Centralised - Variation EMEA/H/C/577/IA/40, 41 (2009)1055 of 11/02/2009
23/02/2009 Centralised - Variation EMEA/H/C/577/IA/45
Updated with Decision(2009)5599 of 07/07/2009
30/03/2009 Centralised - Variation EMEA/H/C/577/IA/47
Updated with Decision(2009)5599 of 07/07/2009
01/04/2009 Centralised - Variation EMEA/H/C/577/IB/46
04/06/2009 Centralised - Variation EMEA/H/C/577/II/43
11/06/2009 Centralised - Variation EMEA/H/C/577/IB/49
09/07/2009 Centralised - Variation EMEA/H/C/577/II/44 (2009)5599 of 07/07/2009
11/08/2009 Centralised - Variation EMEA/H/C/577/IA/51
24/11/2009 Centralised - Variation EMEA/H/C/577/IB/52
24/12/2009 Centralised - Renewal EMEA/H/C/577/R/50 (2009)10687 of 21/12/2009
06/04/2010 Centralised - Variation EMEA/H/C/577/IB/53
Updated with Decision(2010)5328 of 27/07/2010
29/07/2010 Centralised - Variation EMEA/H/C/577/X/48 (2010)5328 of 27/07/2010
10/08/2010 Centralised - Variation EMEA/H/C/577/IA/55/G
Updated with Decision(2010)7535 of 25/10/2010
30/09/2010 Centralised - Variation EMEA/H/C/577/II/54/G
04/10/2010 Centralised - Variation EMEA/H/C/577/IB/56
27/10/2010 Centralised - Variation (2010)7535 of 25/10/2010
28/06/2011 Centralised - Variation EMEA/H/C/577/IB/57
Updated with Decision(2011)6631 of 19/09/2011
31/08/2011 Centralised - Variation EMEA/H/C/577/IA/58/G
Updated with Decision(2011)6631 of 19/09/2011
22/09/2011 Centralised - Variation (2011)6631 of 19/09/2011
26/01/2012 Centralised - Variation EMEA/H/C/577/IB/61
Updated with Decision(2012)2328 of 30/03/2012
04/04/2012 Centralised - Variation EMEA/H/C/577/II/60 (2012)2328 of 30/03/2012
02/07/2012 Centralised - Variation EMEA/H/C/577/II/59 (2012)4521 of 27/06/2012
24/07/2012 Centralised - Variation EMEA/H/C/577/II/63 (2012)5279 of 20/07/2012
13/02/2013 Centralised - Variation EMEA/H/C/577/IB/67
Updated with Decision(2013)6596 of 02/10/2013
04/10/2013 Centralised - Variation EMEA/H/C/577/II/65 (2013)6596 of 02/10/2013