Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Lyrica   
Auth. number : EU/1/04/279
Active substance : pregabalin
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N03 - Antiepileptics
Pharmacological subgroup: N03A - Antiepileptics
Chemical subgroup: N03AX - Other antiepileptics
Chemical substance: N03AX16 - Pregabalin
(See WHO ATC Index)
Indication: Neuropathic pain: Lyrica is indicated for the treatment of peripheral and central neuropathic pain in adults.
Epilepsy: Lyrica is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Generalised Anxiety Disorder: Lyrica is indicated for the treatment of Generalised Anxiety Disorder (GAD) 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
08/07/2004 Centralised - Authorisation EMEA/H/C/546 (2004)2720 of 06/07/2004
20/09/2004 Centralised - Variation EMEA/H/C/546/IB/1
Updated with Decision(2005)1473 of 10/05/2005
13/04/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/546/IB/3
13/05/2005 Centralised - Variation (2005)1473 of 10/05/2005
12/07/2005 Centralised - Variation EMEA/H/C/546/II/2 (2005)2734 of 08/07/2005
21/11/2005 Centralised - Variation EMEA/H/C/546/II/6 (2005)4528 of 17/11/2005
22/03/2006 Centralised - Variation EMEA/H/C/546/II/4 (2006)961 of 20/03/2006
17/05/2006 Centralised - Variation EMEA/H/C/546/X/5 (2006)2032 of 15/05/2006
06/07/2006 Centralised - Variation EMEA/H/C/546/II/8 (2006)3142 of 04/07/2006
03/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/546/II/9
05/09/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/546/IA/12
12/09/2006 Centralised - Variation EMEA/H/C/546/II/7 (2006)4123 of 07/09/2006
12/10/2006 Centralised - Notification EMEA/H/C/546/N/10
Updated with Decision(2007)3285 of 29/06/2007
01/11/2006 Centralised - Variation EMEA/H/C/546/II/11 (2006)5332 of 30/10/2006
19/01/2007 Centralised - Variation EMEA/H/C/546/II/13 (2007)186 of 17/01/2007
19/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/546/IA/14
23/05/2007 Centralised - Notification EMEA/H/C/546/N/15
Updated with Decision(2007)3285 of 29/06/2007
23/05/2007 Centralised - Notification EMEA/H/C/546/N/16
Updated with Decision(2007)3285 of 29/06/2007
15/06/2007 Centralised - Variation EMEA/H/C/546/IA/18
Updated with Decision(2007)6741 of 18/12/2007
05/07/2007 Centralised - Variation EMEA/H/C/546/II/17 (2007)3285 of 29/06/2007
09/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/546/IB/19
26/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/546/IB/20
21/12/2007 Centralised - Variation EMEA/H/C/546/II/21 (2007)6741 of 18/12/2007
04/03/2008 Centralised - Variation EMEA/H/C/546/II/22 (2008)880 of 29/02/2008
31/03/2008 Centralised - Variation EMEA/H/C/546/II/23 (2008)1252 of 27/03/2008
11/04/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/546/IA/25
24/12/2008 Centralised - Variation EMEA/H/C/546/II/27 (2008)8972 of 22/12/2008
05/02/2009 Centralised - Variation EMEA/H/C/546/IA/32
Updated with Decision(2009)4339 of 29/05/2009
05/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/546/IA/31
17/02/2009 Centralised - Variation EMEA/H/C/546/II/28 (2009)1123 of 13/02/2009
03/06/2009 Centralised - Renewal EMEA/H/C/546/R/29 (2009)4339 of 29/05/2009
11/08/2009 Centralised - Variation EMEA/H/C/546/II/33 (2009)6382 of 07/08/2009
24/08/2009 Centralised - Variation EMEA/H/C/546/II/34 (2009)6586 of 20/08/2009
16/09/2009 Centralised - Variation (rejected) EMEA/H/C/546/II/24 (2009)7053 of 14/09/2009
24/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/546/IB/36
24/12/2009 Centralised - Variation EMEA/H/C/546/II/35 (2009)10693 of 21/12/2009
11/03/2010 Centralised - Variation EMEA/H/C/546/IA/38
Updated with Decision(2010)2930 of 29/04/2010
04/05/2010 Centralised - Variation EMEA/H/C/546/II/37 (2010)2930 of 29/04/2010
26/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/546/IA/42/G
10/06/2010 Centralised - Variation EMEA/H/C/546/X/30 (2010)3807 of 08/06/2010
16/06/2010 Centralised - Variation EMEA/H/C/546/II/39 (2010)4122 of 14/06/2010
31/08/2010 Centralised - Variation EMEA/H/C/546/II/41 (2010)6018 of 26/08/2010
30/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/546/II/40
04/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/546/IA/43/G
03/01/2011 Centralised - Notification EMEA/H/C/546/N/44
Updated with Decision(2011)4461 of 17/06/2011
28/03/2011 Centralised - Variation EMEA/H/C/546/IG/44/G
Updated with Decision(2011)4461 of 17/06/2011
23/06/2011 Centralised - Variation EMEA/H/C/546/II/45 (2011)4461 of 17/06/2011
19/08/2011 Centralised - Variation EMEA/H/C/546/IB/48
Updated with Decision(2011)7779 of 24/10/2011
26/10/2011 Centralised - Variation EMEA/H/C/546/II/47 (2011)7779 of 24/10/2011
24/11/2011 Centralised - Variation EMEA/H/C/546/II/49 (2011)8674 of 22/11/2011
03/02/2012 Centralised - Notification EMEA/H/C/546/N/53
Updated with Decision(2014)1053 of 13/02/2014
15/02/2013 Centralised - Variation EMEA/H/C/546/IB/58
Updated with Decision(2014)1053 of 13/02/2014
17/04/2013 Centralised - Variation EMEA/H/C/546/IB/60
Updated with Decision(2014)1053 of 13/02/2014
02/07/2013 Centralised - Notification EMEA/H/C/546/N/61
Updated with Decision(2014)1053 of 13/02/2014
19/11/2013 Centralised - Variation EMEA/H/C/546/IB/64
Updated with Decision(2014)1053 of 13/02/2014
23/01/2014 Centralised - Variation EMEA/H/C/546/II/63
Updated with Decision(2015)375 of 22/01/2015
17/02/2014 Centralised - Yearly update (2014)1053 of 13/02/2014
16/05/2014 Centralised - Variation EMEA/H/C/546/IAin/68
Updated with Decision(2015)375 of 22/01/2015
09/07/2014 Centralised - Variation EMEA/H/C/546/IB/67
Updated with Decision(2015)375 of 22/01/2015
19/08/2014 Centralised - Notification EMEA/H/C/546/N/72
Updated with Decision(2015)375 of 22/01/2015
18/12/2014 Centralised - Variation EMEA/H/C/546/WS/628
26/01/2015 Centralised - Yearly update (2015)375 of 22/01/2015
26/03/2015 Centralised - Variation EMEA/H/C/546/WS/630