Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Prialt   
Auth. number : EU/1/04/302
INN : ziconotide
Orphan status based on designation EU/3/01/048 added on 24/02/2005
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N02 - Analgesics
Pharmacological subgroup: N02B - Other analgesics and antipyretics
Chemical subgroup: N02BG - Other analgesics and antipyretics
Chemical substance: N02BG08 - Ziconotide
(See WHO ATC Index)
Indication: Treatment of severe, chronic pain in adults who require intrathecal (IT) analgesia
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
24/02/2005 Centralised - Authorisation EMEA/H/C/551 (2005)461 of 21/02/2005
11/05/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/551/IA/1
22/03/2006 Centralised - Variation EMEA/H/C/551/X/2 (2006)960 of 20/03/2006
03/04/2006 Centralised - Variation EMEA/H/C/551/II/3 (2006)1348 of 29/03/2006
24/05/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/551/IA/6
02/06/2006 Centralised - Variation EMEA/H/C/551/II/4 (2006)2222 of 31/05/2006
02/08/2006 Centralised - Annual reassessment EMEA/H/C/551/S/5 (2006)3533 of 28/07/2006
18/09/2006 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/551/T/7 (2006)4185 of 13/09/2006
06/10/2006 Centralised - Variation EMEA/H/C/551/IA/8
Updated with Decision(2007)2117 of 11/05/2007
15/05/2007 Centralised - Variation (2007)2117 of 11/05/2007
19/06/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/551/IA/11
19/06/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/551/IA/12
03/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/551/IB/10
04/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/551/IA/15
04/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/551/IA/14
04/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/551/IA/16
04/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/551/IA/13
25/07/2007 Centralised - Annual reassessment EMEA/H/C/551/S/9 (2007)3640 of 20/07/2007
23/01/2008 Centralised - Notification EMEA/H/C/551/N/17
Updated with Decision(2008)4676 of 25/08/2008
18/02/2008 Centralised - Variation EMEA/H/C/551/IA/19
Updated with Decision(2008)4676 of 25/08/2008
27/08/2008 Centralised - Annual reassessment EMEA/H/C/551/S/21 (2008)4676 of 25/08/2008
13/02/2009 Centralised - Notification EMEA/H/C/551/N/25
Updated with Decision(2009)6880 of 04/09/2009
13/02/2009 Centralised - Variation EMEA/H/C/551/IA/26
Updated with Decision(2009)6880 of 04/09/2009
17/03/2009 Centralised - Variation EMEA/H/C/551/IA/28
Updated with Decision(2009)6880 of 04/09/2009
30/04/2009 Centralised - Annual reassessment EMEA/H/C/551/S/27
07/09/2009 Centralised - Variation (2009)6880 of 04/09/2009
22/09/2009 Centralised - Notification EMEA/H/C/551/N/29
Updated with Decision(2010)121 of 12/01/2010
14/01/2010 Centralised - Renewal EMEA/H/C/551/R/30 (2010)121 of 12/01/2010
19/04/2010 Centralised - Notification EMEA/H/C/551/N/31
Updated with Decision(2012)758 of 06/02/2012
28/07/2010 Centralised - Annual reassessment EMEA/H/C/551/S/32
30/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/551/II/33
27/07/2011 Centralised - Variation EMEA/H/C/551/IB/36
Updated with Decision(2012)758 of 06/02/2012
27/07/2011 Centralised - Annual reassessment EMEA/H/C/551/S/34
08/02/2012 Centralised - Variation (2012)758 of 06/02/2012
24/09/2012 Centralised - Annual reassessment EMEA/H/C/551/S/38 (2012)6703 of 20/09/2012
27/03/2013 Centralised - Variation EMEA/H/C/551/IB/39
Updated with Decision(2014)327 of 17/01/2014
21/01/2014 Centralised - Annual reassessment EMEA/H/C/551/S/40 (2014)327 of 17/01/2014
22/09/2014 Centralised - Renewal EMEA/H/C/551/R/45 (2014)6783 of 18/09/2014