Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: BeneFIX   
Auth. number : EU/1/97/047
INN : Nonacog alfa
ATC: Anatomical main group: B - Blood and blood forming organs
Therapeutic subgroup: B02 - Antihemorrhagics
Pharmacological subgroup: B02B - Vitamin K and other hemostatics
Chemical subgroup: B02BD - Blood coagulation factors
Chemical substance: B02BD04 - Coagulation factor IX
(See WHO ATC Index)
Indication: Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).
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
28/08/1997 Centralised - Authorisation EMEA/H/C/139 (97)2752 of 27/08/1997
23/11/1998 Centralised - Variation EMEA/H/C/139/II/3 (1998)3500 of 11/11/1998
18/01/1999 Centralised - Variation EMEA/H/C/139/I/4 (1999)40 of 11/01/1999
04/04/1999 Centralised - Annual reassessment EMEA/H/C/139/S/9 (1999)837 of 29/03/1999
12/04/1999 Centralised - Notification EMEA/H/C/139/N/10 (1999)898 of 08/04/1999
17/01/2001 Centralised - Annual reassessment EMEA/H/C/139/S/16
25/04/2001 Centralised - Variation EMEA/H/C/139/II/15 (2001)851 of 23/04/2001
25/04/2001 Centralised - Variation EMEA/H/C/139/II/17 (2001)851 of 23/04/2001
25/10/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/II/18
29/01/2002 Centralised - Annual reassessment EMEA/H/C/139/R/20 (2002)378 of 23/01/2002
07/02/2002 Centralised - Variation EMEA/H/C/139/II/21 (2002)479 of 05/02/2002
03/07/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/I/23
24/09/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/I/26
28/10/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/II/25
19/11/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/I/28
05/02/2003 Centralised - Renewal EMEA/H/C/139/R/24 (2003)493 of 03/02/2003
18/09/2003 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/139/T/30 (2003)3342 of 16/09/2003
02/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/II/31
04/11/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/II/29
10/11/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/I/34
05/03/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/II/33
27/07/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/IA/36
04/08/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/II/35
23/08/2004 Centralised - Annual reassessment EMEA/H/C/139/S/32 (2004)3263 of 18/08/2004
26/10/2004 Centralised - Annual reassessment EMEA/H/C/139/S/38
11/11/2004 Centralised - Variation EMEA/H/C/139/IA/40
Updated with Decision(2005)3265 of 23/08/2005
01/04/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/II/39
27/06/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/IA/44
05/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/IB/42
25/08/2005 Centralised - Variation (2005)3265 of 23/08/2005
26/08/2005 Centralised - Variation EMEA/H/C/139/II/43 (2005)3273 of 24/08/2005
10/10/2005 Centralised - Variation EMEA/H/C/139/IB/47
Updated with Decision(2005)6019 of 23/12/2005
21/11/2005 Centralised - Annual reassessment EMEA/H/C/139/S/46
28/12/2005 Centralised - Variation EMEA/H/C/139/II/45 (2005)6019 of 23/12/2005
02/03/2006 Centralised - Variation EMEA/H/C/139/II/49, 48 (2006)689 of 28/02/2006
26/04/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/IA/53
23/05/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/IA/56
28/09/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/II/50
28/09/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/II/51
24/10/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/II/52
07/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/IA/62
19/02/2007 Centralised - Annual reassessment EMEA/H/C/139/S/58 (2007)537 of 15/02/2007
02/04/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/II/59
04/05/2007 Centralised - Variation EMEA/H/C/139/II/60 (2007)2004 of 02/05/2007
31/07/2007 Centralised - Variation EMEA/H/C/139/X/55, 57 (2007)3755 of 30/07/2007
01/08/2007 Centralised - Variation EMEA/H/C/139/X/55, 57 (2007)3756 of 30/07/2007
09/08/2007 Centralised - Renewal EMEA/H/C/139/R/63 (2007)3866 of 07/08/2007
19/12/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/II/64
20/12/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/IA/67
05/02/2008 Corrigendum EMEA/H/C/139/X/55, 57 (2007)3756 corr of 01/02/2008
05/02/2008 Corrigendum EMEA/H/C/139/R/63 (2007)3866 corr of 01/02/2008
18/02/2008 Centralised - Annual reassessment EMEA/H/C/139/S/65 (2008)695 of 14/02/2008
26/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/II/66
28/04/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/II/68
07/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/IA/71
18/08/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/IB/72
01/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/II/69
01/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/II/70
25/02/2009 Centralised - Annual reassessment EMEA/H/C/139/S/74 (2009)1344 of 23/02/2009
24/04/2009 Centralised - Variation EMEA/H/C/139/II/73 (2009)3186 of 22/04/2009
05/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/IA/80
16/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/II/78
30/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/II/75
02/07/2009 Centralised - Variation EMEA/H/C/139/II/77 (2009)5389 of 30/06/2009
29/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/II/79
30/10/2009 Centralised - Variation EMEA/H/C/139/II/82 (2009)8509 of 28/10/2009
15/12/2009 Centralised - Variation EMEA/H/C/139/IA/86
Updated with Decision(2010)1765 of 15/03/2010
20/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/II/81
03/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/II/85
17/02/2010 Centralised - Notification EMEA/H/C/139/N/87
Updated with Decision(2010)3075 of 05/05/2010
17/03/2010 Centralised - Variation (2010)1765 of 15/03/2010
08/04/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/IA/90
09/04/2010 Centralised - Variation EMEA/H/C/139/IA/89/G
Updated with Decision(2010)4994 of 13/07/2010
03/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/II/83
07/05/2010 Centralised - Annual reassessment EMEA/H/C/139/S/84 (2010)3075 of 05/05/2010
08/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/IB/92
15/07/2010 Centralised - Variation (2010)4994 of 13/07/2010
19/08/2010 Centralised - Variation EMEA/H/C/139/IB/91/G
Updated with Decision(2011)1792 of 14/03/2011
05/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/IB/94
29/10/2010 Centralised - Notification EMEA/H/C/139/N/95
Updated with Decision(2011)1792 of 14/03/2011
22/11/2010 Centralised - Notification EMEA/H/C/139/N/96
Updated with Decision(2011)1792 of 14/03/2011
01/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/WS/117
01/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/II/88/G
18/03/2011 Centralised - Variation (2011)1792 of 14/03/2011
22/03/2011 Centralised - Variation EMEA/H/C/139/IB/98
Updated with Decision(2011)4634 of 23/06/2011
18/04/2011 Centralised - Variation EMEA/H/C/139/IB/99
Updated with Decision(2011)4634 of 23/06/2011
02/05/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/139/II/93
28/06/2011 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/139/T/100 (2011)4634 of 23/06/2011
25/07/2012 Centralised - Renewal EMEA/H/C/139/R/107 (2012)5292 of 20/07/2012
28/08/2012 Centralised - Variation EMEA/H/C/139/X/103 (2012)6032 of 23/08/2012
20/02/2013 Centralised - 2-Monthly update EMEA/H/C/139/II/108 (2013)1016 of 18/02/2013
19/07/2013 Centralised - Notification EMEA/H/C/139/N/116
Updated with Decision(2014)6189 of 26/08/2014
19/09/2013 Centralised - Variation EMEA/H/C/139/II/117
Updated with Decision(2014)6189 of 26/08/2014
03/02/2014 Centralised - Variation EMEA/H/C/139/IA/124
Updated with Decision(2014)6189 of 26/08/2014
28/08/2014 Centralised - Yearly update (2014)6189 of 26/08/2014