Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Champix   
Auth. number : EU/1/06/360
INN : varenicline tartrate
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N07 - Other nervous system drugs
Pharmacological subgroup: N07B - Drugs used in addictive disorders
Chemical subgroup: N07BA - Drugs used in nicotine dependence
Chemical substance: N07BA03 - Varenicline
(See WHO ATC Index)
Indication: indicated for smoking cessation in adults
Marketing Authorisation Holder: Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, 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
28/09/2006 Centralised - Authorisation EMEA/H/C/699 (2006)4345 of 26/09/2006
18/12/2006 Centralised - Notification EMEA/H/C/699/N/1
Updated with Decision(2007)1937 of 26/04/2007
21/12/2006 Centralised - Variation EMEA/H/C/699/IB/2
Updated with Decision(2007)1937 of 26/04/2007
30/01/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/699/IB/4
20/02/2007 Centralised - Notification EMEA/H/C/699/N/3
Updated with Decision(2007)1937 of 26/04/2007
22/03/2007 Centralised - Variation EMEA/H/C/699/IB/5
Updated with Decision(2007)1937 of 26/04/2007
30/04/2007 Centralised - Variation EMEA/H/C/699/II/6 (2007)1937 of 26/04/2007
02/10/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/699/IB/7
15/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/699/IB/8
03/03/2008 Centralised - Variation EMEA/H/C/699/II/10, 11 (2008)840 of 28/02/2008
19/03/2008 Centralised - Variation EMEA/H/C/699/IB/12
Updated with Decision(2008)4410 of 08/08/2008
08/04/2008 Centralised - Variation EMEA/H/C/699/IA/13
Updated with Decision(2008)4410 of 08/08/2008
13/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/699/IB/15
01/08/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/699/IB/18
12/08/2008 Centralised - Variation EMEA/H/C/699/II/16 (2008)4410 of 08/08/2008
27/11/2008 Centralised - Variation EMEA/H/C/699/II/19 (2008)7607 of 25/11/2008
17/12/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/699/IA/20
09/04/2009 Centralised - Variation EMEA/H/C/699/II/21 (2009)2858 of 07/04/2009
05/08/2009 Centralised - Variation EMEA/H/C/699/II/24 (2009)6282 of 03/08/2009
11/08/2009 Centralised - Variation EMEA/H/C/699/IB/25
Updated with Decision(2009)9779 of 30/11/2009
01/09/2009 Centralised - Variation EMEA/H/C/699/II/22, 23 (2009)6714 of 27/08/2009
05/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/699/II/27
02/12/2009 Centralised - Variation EMEA/H/C/699/II/28 (2009)9779 of 30/11/2009
07/12/2009 Centralised - Variation EMEA/H/C/699/II/26 (2009)9920 of 03/12/2009
15/12/2009 Corrigendum
14/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/699/IA/31
27/10/2010 Centralised - Variation EMEA/H/C/699/II/29 (2010)7525 of 25/10/2010
23/12/2010 Centralised - Variation EMEA/H/C/699/II/30 (2010)9641 of 20/12/2010
15/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/699/IG/44/G
09/06/2011 Centralised - Renewal EMEA/H/C/699/R/32 (2011)4175 of 07/06/2011
23/06/2011 Centralised - Variation EMEA/H/C/699/II/33 (2011)4463 of 17/06/2011
23/11/2011 Centralised - Variation EMEA/H/C/699/II/34 (2011)8653 of 21/11/2011
25/01/2012 Centralised - Variation EMEA/H/C/699/II/36 (2012)419 of 20/01/2012
26/03/2012 Centralised - Variation EMEA/H/C/699/II/38 (2012)2038 of 21/03/2012
17/04/2012 Centralised - Variation EMEA/H/C/699/II/39 (2012)2539 of 13/04/2012
22/11/2012 Centralised - Variation EMEA/H/C/699/II/41 (2012)8580 of 19/11/2012
21/02/2013 Centralised - Variation EMEA/H/C/699/II/43
Updated with Decision(2014)3944 of 06/06/2014
13/03/2013 Centralised - Modification EMEA/H/C/699/PSUR/9 (2013)1535 of 11/03/2013
27/06/2013 Centralised - Variation EMEA/H/C/699/II/45
Updated with Decision(2014)3944 of 06/06/2014
14/11/2013 Centralised - Variation EMEA/H/C/699/IB/48/G
Updated with Decision(2014)3944 of 06/06/2014
21/11/2013 Centralised - Variation EMEA/H/C/699/II/47
Updated with Decision(2014)3944 of 06/06/2014
20/02/2014 Centralised - Variation EMEA/H/C/699/II/49
11/06/2014 Centralised - Yearly update (2014)3944 of 06/06/2014
25/09/2014 Centralised - Variation EMEA/H/C/699/II/51
23/10/2014 Centralised - Variation EMEA/H/C/699/IAin/55
20/11/2014 Centralised - Variation EMEA/H/C/699/II/53